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Fronter Insight -No.03

其他分类其他2023-09-18
249

FRONTERA
 INSIGHT

Innovation      Efficiency      Integrity      Rigor

No.03   General Issue No.3

CONTENTS

RD Team Profile
The Trip of China Team Colleagues to the US
How Delightful to Have a Friend Coming from the US
Technology Sharing and Life Fun from Helen

It's Grateful to Have You
Strictly Check the Product Delivery 
Removal of Data Integrity Bugs
Story Behind the Mid-Year Budget Revisit,Adjustment and Forecast
Story Behind Pest Control

Small and Beautiful "Orphan Drug"
Immunogenicity of Gene Therapy 

Training Events in Summer

Anniversary
Employee Recognition - US
Wedding News
New Face in Frontera

Frontera News Brief

US-China Team Interaction

Department Information

People in Frontera

Training Zone

Science Class

Life Sharing

A Tour of Western Sichuan

Three years have passed in a flash, and we're in the midst of a brand-new harvest in the fall.
August is Frontera's birth month. Since the very beginning of 2020, we have been committed to producing high-quality, affordable AAV gene therapy drugs to patients in China and around the world. We never stop and never slack off.
Over the past three years, we've achieved 4 new investigation product IND application with 5 indications, covering different indications, such as ophthalmic rare/chronic diseases, and hemophilia B.
We have established a technical platform for the large-scale GMP production of AAV gene drugs, the production scale can meet therapeutic needs of patients with different indications, the product quality meets requirements of clinical trials, and we successfully achieved the goal of controlling the empty rate to less than 1%, which is an absolutely remarkable achievement.
We are so grateful for the tremendous contribution of each Frontera people with great passion in the past three years. Without your continuous efforts and great teamwork, we couldn't make so plenty success which is unbelievable and lead Frontera to a leading position in China.
For company perspective, we have a common mission, that is, to contribute to human being’s healthcare, and we expect that we will continue to proceed with ongoing projects, and expecting major breakthrough in FT2.0 project, to promote China's gene therapy drugs to the world and benefit more patients.
Hopefully we will keep our original intention, embarking on a new journey with great vision and ambitious.

Notes from CEO

FT-004 Phase I/II Clinical Study National  Investigator Meeting 

Company Events

Frontera News Brief

Frontera Insight Frontera News Brief

On July 10th,2023, at the opening ceremony of the 15th Suzhou Entrepreneurship Week for International Elites, Frontera Therapeutics was awarded the title of "2023 Gusu Major Innovative Team", with its innovative practice in the field of gene therapy and internationalized R&D and production platform.

 Frontera’s Third Gene Therapy Treatment IND has been Approved by CDE

An application for an investigational study in human Hemophilia B patients with FT-004, an innovative gene therapy drug independently developed by Frontera Therapeutics was approved by the Center for Drug Evaluation (CDE) of China National Medical Products Administration for the indication of hemophilia B (endogenous FIX activity ≤ 2%). This is the third innovative AAV gene therapy product IND approval ed for investigational clinical studies of by Frontera Therapeutics.

Frontera Therapeutics Successfully Convenes National Investigator Meeting for FT-004

Frontera Therapeutics was Awarded the Title of "2023 Gusu Major Innovative Team"

On August 20,2023, the national investigators' meeting of Frontera Therapeutics FT-004 Phase I/II clinical study was successfully held in Suzhou, which marked the beginning of a new journey for Frontera Therapeutics in the field of hemophilia B treatment as well. Professor Wu Depei, President Miao Liyan, Professor Yu Ziqiang from the First Affiliated Hospital of Soochow University and other investigators from 7 participating sites hospital attended the meeting. Dr. Li Xinyan, CEO of Frontera Therapeutics, and the research team witnessed this milestone moment together!

Frontera’s AAV Gene Therapy Approved for New Indication Targeting DME

On August 21,Frontera's FT-003 injection for DME was approved for clinical trial by CDE. This is the 1st clinical trial approved for DME in China.

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FT-004 Phase I/II Clinical Study National Investigator Meeting Successfully Held

Wan Fang form CO Dept.

On August 20,2023, the National Investigators Conference of FT-004 Phase I/II Clinical Study was successfully held beside the beautiful Jinji Lake, which marked the official launch of FT-004 clinical trial, and we are further on the road of providing patients with high-quality and affordable gene therapy products.
The conference kicked off with a speech by Professor Wu Depei, the national leading PI from the First Affiliated Hospital of Soochow University. He shared the progress and current status of the AAV gene therapy in hemophilia B and encouraged all investigators to high quality and efficiently complete the clinical trials with bold innovation, scientific verification, and standardize operation.

Frontera Insight Company Events

Professor Miao Liyan, Deputy Secretary of the Party Committee, Executive Vice President, and Executive Director of the Clinical Trial Institution Office of the First Affiliated Hospital of Soochow University was also invited to made a presentaion. She emphasized that this clinical study is the second gene therapy product collaborated between the hospital and Frontera, she also looked forward to the joint efforts of all investigators to complete the FT-004 clinical trial as soon as possible.
Due to all participants enthusiastically spoke and deeply discussed the use of hormones, sample collection, patient management and other key points during the study, the conference was extended to be closed until 12:10 am.

We would like to sincerely thank EHS, HR, BD, IT, E&E, Medical and other departments for their support and cooperation.
Let's continue to work hard to produce high-quality and affordable gene therapy products to patients and work together to create a more brilliant future.

RD Team Profile

Currently, there are seven members in Research (RD) Team.
ZDDepartment Head of RD.
Amy Flow cytometry tester, and a new dog mom.
BrendanBaculovirus and AAV producer/tester, pipeline program supporter.
HongExperienced in chemistry development and gene editing, inspired to be a drug developer to make AAV gene therapy available and affordable to many patients.
JiayunAAV genome innovator, a chess dad and coach.
KyleExpert in virology, molecular biology, and immunofluorescence microscopy enthusiast. Cat dad to three spoilt cats.
MattResponsible for producing bacmid and rBV for multiple FT2.0 programs, outgoing, party person, baseball enthusiast.

What does RD team mainly do?
As the engine for developing innovative drugs, the goal of RD team is to invent and develop novel, efficacious and safe AAV gene therapy drugs to treat human diseases. There are THREE major functions in RD – pipeline establishment, vector construction / screening, and early proof of concept.
  • Pipeline establishment – Evaluate new targets, propose new ideas and build up Frontera’s gene therapy portfolio with help from the clinical team, investors, KOLs, and other teams.
  • Vector construction / screening – Design AAV vectors, improve capsid transduction efficiency, tropism, and safety to target challenging diseases. Establish procedures for baculovirus genome engineering and rBV generation, and produce high quality research-grade bacmids, baculoviruses and AAVs with help from CROs and TechOps (PD and AD) to support programs and capsid discovery.
  • Early proof of concept - Conduct in vitro and in vivo screenings to identify lead candidates.

Frontera Insight  US-China Team Interaction

Frontera Insight Company Events

ZD Shi from RD Dept.

Frontera Insight  US-China Team Interaction

Frontera Insight  US-China Team Interaction

Frontera's communication between China and the US team kicked off in 2023 after COVID-19. I was fortunate enough to go to this "Net Friends Meeting" in August. When the familiar voices and names became vivid images in front of me, I felt exciting.
The one-week visit was very fruitful. I participated in many face-to-face meetings and one-on-one talkings, which brought us closer to each other and made our communication more smooth. The visit to laboratories and animal rooms gave me a preliminary understanding of US colleagues' working environment. The sharing of regulatory differences between the Chinese and US drug regulatory agencies enhanced the understanding of US colleagues on China's drug regulatory requirements.
I would like to thank all colleagues in US team for their support and assistance during my visit, which enabled me to achieve my working goals, enjoy the scenery of Boston, and taste the food and wine.
This trip made us understand each other better and be more united. China and US teams in  Frontera family will support each other and help each other all the time, which is the driving force of our continuous development.

After a few turns, I came from HOT Suzhou to COOL Boston. With the warm welcome of the US colleagues, my nervousness gradually disappeared and I felt much more relaxd.
Various styles of trophies, figures and cute whiteboard drawings in the US office show everyone’s hard work and reflect the team’s activity. The snacks and convenient kitchen equipment placed in pantry reveal colorfulness of office life. The work tools arranged in different categories, eye-catching signs and humanized design reflect all the professionals wisdom.
After this trip, I have a better understanding of RD&PD, and will have a smoother coordination in technical transfer work. Thanks to the care from my warm-hearted US team colleagues, I had a very fulfilling weeks!
In addition, it is not only my English that has improved, but also my weight...
Thanks to Frontera family, I had an unforgettable trip.

The Trip of China Team Colleagues to the US

Haiwei Zhang from Manufacturing Dept.

Sophie Song form RA & PM Dept.

In the past three years, RD has completed DC nominations for 7 programs, 4 of which have moved into the clinical stage. We expect to complete DC nominations for another 4 programs in the next 9 months and initiate 2 additional programs by the end of 2023, with more to come in 2024. RD team are grateful for the full support from all teams within the company to achieve our goals and milestones. 

How delightful to Have a Friend Coming from the US

Carter Wang from Manufacturing Dept.

With 4 days of hard work, the purification process of 042301DS was completed as scheduled. 22 bottles of DS were delivered to the warehouse in time at 9:30 pm on Aug. 18,2023in time. Downstream production went smoothly without any deviation during purification. With the guidance of technical expert, we did really good job.

89%B,90%B,91%B…… CIMQ linear reading values flash in real time. It was dead silent in the production workshop at this moment. Everyone's eyes were glued to the screen. With the full rAAV UV peak perfectly displayed on the chromatogram, the AEX process achieved successful scaling up. We burst into applause for our hard work in these two months.

It’s late August, Suzhou is still baking under the scorching sun. An online pen pal-Jeffrey Kan, also a technical consultant from downstream, came all the way here. 
Jeff is a Senior Associate Scientist in  Downstream team at the Boston R&D center, where he was responsible for downstream process development and technology transfer for FT-003 and FT-004 projects. Both projects have successfully scaled up to GMP production scale with a 100% success rate. 
Recently, with the cooperation of two sites, the downstream team optimized the AEX chromatography process and successfully reduced empty rate of rAAV vector to less than 1% in the lab scale. 
This time, Jeff traveled across the ocean, working together with Suzhou colleagues and witnessed the successful 500L GMP production of FT-004 042301DS batch.

We have a friend came from the US and then went far away. We said goodbye with a smile and went to the next destination of life. Life is full of surprises and encounters, remain nostalgic and grateful for the people and things that you meet. 

Frontera Insight  US-China Team Interaction

Frontera Insight  US-China Team Interaction

 Part 1: Working together, nervous and excited

Days of hard working made the whole team very tired. However, nothing is a barbecue can not solve. Beer and spicy crawfish! What a wonderful night.

 Part 2:  Eating Together, Beer & Spicy Crawfish

Technology Sharing and Life Fun From Helen

Jiayan He from QC Dept.

But Helen's session wasn't just about technical jargon. She regaled us with delightful anecdotes from her life in Boston. Among her tales was her fondness for fishing, a pastime many of us resonate with. However, fishing in Boston, unlike in China, isn't as simple as casting a line. It requires a formal "fishing license". Venture into the waters without one, and you risk running afoul of the law. But securing this license isn't too tedious. Most fishing stores offer them, and alongside, they provide a handbook detailing a plethora of guidelines – from species-specific fishing seasons to daily catch limits and even size restrictions. These rules, tailored to different regions, are annually updated, all in a bid to preserve the marine ecosystem.

In the sweltering heat of August, we had the pleasure of hosting Helen Feng, affectionately known as the "big sister" from AD. During her visit, she enlightened us with her expert insights on using the HPLC method to determine the empty/full ratio.
During Helen's training session, she delved deep into her professional expertise, captivating the attendees so much so that not a single seat was left vacant.
About the significance of shell rate detection:
In the realm of AAV vector production, alongside generating the desired AAV vectors equipped with the full-length target gene, various impurities arise. These include virus particles void of any content, those partially filled with genes, others brimming with excess genomic DNA, fragments from both host and plasmid DNA, and even nucleases. The intricacies of AAV vector production emphasize the importance of consistent product quality, the purity of the vectors, and batch-to-batch uniformity. While metrics like vector titer, yield, and bioactivity are pivotal, the ultimate goal lies in refining the purity of these AAV vectors. This translates to the daunting challenge of filtering out defective vectors – particularly those empty shells or those bearing any DNA fragments apart from the full-length gene.

Sharing about  life in Boston:

We are looking forward to see more communication opportunities to increase technology sharing and life interactions between the U.S. and China team.

Frontera Insight  US-China Team Interaction

Frontera Insight  US-China Team Interaction

Small and Beautiful "Orphan Drug"

Frontera Insight  Science Class

Meng Li from RA and Project Management Dept.

In the most recent All Hands Meeting, guys with sharp eyes may have noticed a new word: applying for "orphan drug". Like a curious baby, let’s follow the footsteps and come to know "Orphan Drug"!
Why is it called "orphan drug"?
Didn't you find the name very interesting! Although the name "orphan" sounds pathetic, actually it is not a drug for orphans. The naming of Orphan Drug is based on characteristics of the drug market. There is a category of diseases called "rare diseases", which are very rare and only affect a small number of patients; those patients are like “abandoned orphans” because their condition rarely catches public attention or research. Although the name may sound pathetic, "orphan drugs" help people with rare diseases, gave them the attention and opportunity to be treated so that they will no longer be ignored and isolated like orphans. This also reflects social care and an effort of making medical progress.
What are the benefits of being an "orphan drug"?
To encourage the development of "orphan drug", a series of relevant policies have been introduced in various countries.  (Table Below)

USA: There is an Orphan Drug Designation (ODD) procedure (Figure 1). ODD is a qualification granted by the FDA Office of Orphan Products Development (OOPD) to eligible drugs for the prevention, treatment, and diagnosis of rare diseases. FDA has well-defined criteria for rare diseases: affect less than 200,000 people in the United States. Because the prevalence and incidence of rare diseases are dynamic, FDA does not have a standard catalogue of rare disease. 

*Incentive policies in the US and EU are from FDA and EMA websites, respectively.
China's incentive policies are from the response of the National Medical Products Administration on June 29,2022 to Recommendation 5196 of the Fifth Session of the Thirteenth National People's Congress.

EU: There are orphan drug designation procedures (Figure 2). The Committee for Orphan Medicinal Products (COMP) is responsible for reviewing orphan drug designation applications of drugs to diagnose, prevent, or treat rare diseases; orphan drug designation is granted by the European Commission (EC) according to the COMP's positive opinion. Rare disease is defined as a disease with prevalence less than five per million, by the European Union. 

* U.S. orphan drug applications can be submitted at any time; timing will be counted since the obtain of ODD number. 

*Orphan drug applications in the EU can be submitted on a monthly basis and must be submitted before deadline of that month; the dates of Review Day 1, Review Day 60, and Review Day 90 will be posted on the EMA website in advance. 

Closing Words
Now you should have known why the "orphan drug" is small and beautiful: "small" is because it is designated to patients with rare disease, with small population and small market; "Beautiful" is because once defined as an "orphan drug", it will be able to acquire policy benefits in various countries, thus greatly shortening development cycle with reduced cost, and bringing positive  expectations for patients with rare disease. 
Let's look forward to Frontera's orphan drug application!

Frontera Insight  Science Class

China: There is only a catalogue of rare diseases without a designation procedure.

How to prove that our product is an "orphan drug"?

The body has a series of defense lines against foreign substances; the first line is the physical barrier, such as skin, mucosa, etc., while the second line is what we know as “human security” -- the leukocytes, composed of innate and acquired immunity. Innate immunity, as the name suggests, is something a person is born with, which protects against foreign infections in a non-specific way. Acquired (adaptive or specific) immunity requires lymphocytes (T and B cells) to encounter the foreign invader, learn how to attack, and develop memory for that invader, so that they can attack more effectively next time when they are exposed to that invader again; it includes cellular and humoral immunity. 

Immunogenicity of Gene Therapy 

Zhiyan LI form Pharmacovigilance, Clinical Development Dept.

As mentioned above, the body has a series of defense lines against foreign substances. Non-humanized components of the gene therapy products, expressed products and vectors of the imported genes, are all potential antigens (foreigners), which may cause innate and acquired immune responses. Although recombinant adeno-associated virus (rAAV) vectors possess a lot of advantages, the immunogenicity still exists, which may interfere with the efficacy and safety of gene therapy. 

1.How does the immune system respond to foreign substances?

2. Will gene therapy cause any  immune response?

Firstly, many people already have the wild-type AAV and antibodies against AAV in their bodies; these pre-existing antibodies may interfere with the virus-cell interactions and affect the efficacy of gene therapy. Therefore, in the clinical trial eligibility criteria, it is generally specified that titers of the AAV neutralizing antibody should not be too high.
Secondly, based on the potential impact of gene therapy products on the immune system, endpoint evaluations about the humoral and cellular immunity are often required, including the evaluations of drug resistant antibody (ADA), changes of the positive rate and titers of neutralizing antibody (NAb), and levels of the gamma interferons (IFNγ) against the AAV capsid protein and the target protein.

Frontera Insight  Science Class

Frontera Insight  Science Class

Thirdly, to reduce the risk of immunogenicity of gene therapy products, it is commonly to pre-treat subjects with glucocorticoids prior to the gene therapy administration.
Lastly, in general, an appropriate immune response is beneficial, but an excessive immune response may harm the body. What we often called "inflammation" is an inflammatory response due to excessive immune response. Therefore, in course of the clinical trials, we will closely monitor relevant inflammatory responses to protect subjects' safety.

3. How to effectively guide the clinical practice of gene therapy based on the above immune knowledge?

Frontera Insight Department Information

It's Grateful to Have You
-To Frontera's lovely Collegues

Suping Zhao from Manufacturing Dept.

August 2023 is the most peak time of the year for Formulation Team, because of the busy production schedule, the increased number of products and the very tight timeline. This year, our filling volume has expanded, which means much greater challenges for people, equipment and facility.
From June to July, after reactivating the workshop, our colleagues from EE Department efficiently handled the maintenance, calibration, and validation of all necessary equipment.
On July 31st, the intense process of culture medium simulation filling began. Houjuan Mao from upstream and Hongda Zheng from downstream also joined formulation team. This was their first time they dive into such a demanding formulation production, especially the aseptic operations. The day was intense, stretching from 9 am, prepping solutions, to 11 pm as filling concluded. But the team, brimming with youthful resilience, managed three batches, meeting all requirements — a testament to their dedication.
The close-knit scheduling of these three batches came with its challenges. Observing the trio in Formulation grappling with the workload, the QA and Supply Chain teams stepped in to assist. Beibei Zhao, in particular, streamlined the material collection process by meticulously prepping batch materials, a gesture of invaluable efficiency. Meanwhile, Xiaowei Cui and Jing Yu from QA juggled supervising and documenting roles with precision. Post-filling, given the tight turnaround, QA professionals including Xiaowei Cui,Jing Yu, Yingying Qian, and Weiguo Li took on the responsibility of inspecting each bottle — diligently checking and documenting any defects. Their dedication ensured samples were promptly ready for cultivation. Their efforts, nothing short of commendable, left me, as the head of formulation, deeply appreciative.
August was a busy and dynamic month for  Formulation Team, thanks a lot to  great support from so many departments. With everyone aligned in purpose and passion, our future shines bright.

XiaoweI Cui, Yingying Qian ,  Jing Yu and Weiguo Li  of QA department who helped with the light inspection;
Zhaodong Jiang , Zhengquan Liu , Carter Wang, Yanli Wu from upstream and downstream of  Manufacturing department

Beibei Zhao form SC Dep.

A thousand words, turned into a sentence of thanks. Recorded your busy figure, thanks to the big family of these small partners of friendship and mutual help!

Hongda Zheng &Houjuan Mao who help with filling

Jing Yu, Serina Cheng,Qian Wang, and Selina Zhu who helped stack the boxes and put on the outer labels

Frontera Insight Department Information

Strictly Safeguard for Product Delivery – Clinical Products & Consumables

The increasing number of products are going to the clinic stage, and more and more products will be shipped from factory to hospitals, bringing hope to patients. As the final checkpoint of products in the factory, WarehouseTeam always uphold the core values of Frontera, adhere to the patient-centered, and complete the entire delivery process with efficiency and rigor to ensure the safe and timely medication for patients.

The following steps are showed how warehouse team strictly carried out the entire delivery process according to SOPs.

Xueping Qian form SC Dept.

② Wrapped the product tightly in an aluminum foil bag, labelled and evenly covered with dry ice. After the completion of packing, the temperature in the foam box was confirmed to meet the requirement (≤-60℃) and guaranteed the stability of the temperature in transit.

① Per clinical requirements, the batch number, drug number and quantity of the product were carefully checked by two persons to ensure the actual delivery was consistent with the demand.

③ When the requested clinical consumables were to be shipped, the corresponding item number, batch number, and the quantity of every consumable were checked one by one, and separately packed with plastic sealing bags to ensure that the consumables match the use of products.

④ The transportation box of consumables was also important due to some of them being easy to be damaged. All consumables should be put neatly and covered the buffer materials when packing to avoid damage during transportation.

⑤ When the products and consumables were ready to be shipped, the logistics information should be confirmed again. The shipping list and courier receipt were filled, and COA, supply catalogs, and other supportive documents were ensured to be packed with goods.

⑥ After the delivery, records including storage card, equipment use log, warehouse account and ERP system were filled to make sure the data tracking as well as integrity.

Details determine success or failure. 
As an indispensable part of Frontera industrial chain, warehouse plays an important role in the safeguard of the safety, reliability, and timeliness of product. With the growing of Frontera, the task of product delivery become heavier. Warehouse Team will continue to support clinical team to complete every delivery task carefully and efficiently, and contribute our own strength to the completion of Frontera’s mission and vision! 

Frontera Insight Department Information

Frontera Insight Department Information

What is data integrity bug?
The word "Bug" is commonly used in computer world to refer to an error or defect. In the field of data integrity, it can be understood as a defect or potential defect that is against the Data integrity principle (ALCOA+) caused by intentional or unintentional actions of people during various GxP activities. The common bug types include recording errors, record with fading pens, fuzzy records caused by insufficient record blank, not using controlled paper to fill in records, computers that have unclear account rights and responsibilities, using other people's accounts to log in, using shared accounts, non-synchronized time, deleting data, cherry picking data, lack of data backup and so on.

How to avoid data integrity bugs? 
The management of data integrity needs to focus on the establishment of quality system and quality culture at the top level, including determining responsibilities, training and improving process documents; behavior, procedure and technical control at the middle level; and the support process at the bottom level such as audit, evaluation criteria, classification management and validation.
The figure below is a data management model proposed by ISPE.

Form design defects: the form is too simple or too small, which may cause key data missing or unclear records.
Lack of awareness of data owners: personnel are the owner of data generated and is accountable for data integrity. Lack of awareness often leads to intentional or unintentional data integrity issues.
Computer system deficiencies: Systems that lack access control, permission assignment, audit trails, or automatic data transfer capabilities may present potential data integrity issues.
Validation deficiencies: Systems that are put into usage without adequate and scientific validation, thus cannot be demonstrated to be fit for their intended use, present significant compliance and data integrity risks, often resulting in persistent issues.
Other data integrity bugs include the use of chromatism paper for continuous records, faded or unclear handwritten or machine-typed records, uncontrolled storage environments for paper records or backup/archiving, date and time modifications, and system login attempts.

Last but not least:
Data integrity bugs are common, harmful but hard to uncover. On the road of eliminating bugs in data system and on the road of pushing data integrity management to a more mature level, we should always adhere to:
Do not do bad things even though they appear to be insignificant, do not give up doing right things even though they appear to be minor. All the staff participate in, there will be no place for the bug to hide.
We believe that by consistently doing this, we can prevent the collapse of our quality system due to snow-balling of "small" issues.

Remove of Data Integrity Bugs>>

Weiguo Li from QA Dept.

Remove of data integrity bugs, we're on the way. 
At the beginning of 2023, we initiated internal inspection of data integrity, addressing "ineffective system control", one of the data integrity topics in FDA warning letters and EMA non-compliance reports. This work was strongly supported by the management and various departments of Suzhou plant and lasted for nearly five months. During this period, we inspected more than 80 pieces of equipment, and the total inspected items reached more than 1,800 pieces. The problems found were recorded and tracked for correction. Through the inspection, the correct configuration and compliance management of key GMP systems are ensured, the awareness of data integrity is further enhanced, and the improvement of the quality system is achieved.
The photos below are some footages from the inspection.

Quality system deficiency: paper based system, computerized system or data are not managed in the whole life cycle. Absence of any part can cause management errors.
Process deficiency: Operations cannot be completed as required due to unclear or impracticable process requirements.

What causes data integrity bugs? 

Frontera Insight Department Information

Frontera Insight Department Information

Story Behind the Mid-Year Budget Revisit, Adjustment and Forecast

Luna Zhang from Fin Dept.

I joined Frontera as Associate Manager of FP&A in June 2023. I was impressed by colleagues’ passion during the summary of R&D progress in mid-year, and decided to work with them and complete my top prioritized task of the mid-year budget review, adjustment and forecast which was presented in the coming board meeting.
As a newcomer, it was a best starting point to get familiar with the company’s operation, annual goal, and the R&D progress from the review of budget. I discussed with my leader to confirm the details of the task, including sorting out the historical data and optimizing the current template. Because no IT system to process the finance data, I spend much longer than expected to manually classify thousands of payment records and massive OA data. My persistence was finally rewarded when I got valuable data to support the future work. During sorting out data, I knew more colleagues. When all preparation was done, I sent the data to the budget owner in each department. It was wonderful that all departments submitted the mid-year reviewed budget timely. Here, I would like to sincerely thank all who made efforts during the task.

During past one month, I deeply realized that budgeting is an important starting and with budget enforcement, analysis, supervision, and assessment to compose of the budget work system. The system is a critical bridge throughout the company’s strategy implementation and operation. With the understanding of the significance of budgeting, I believe there is still a lot of work to do. The methods of budget management need to be constantly upgraded in a fast-growing company. For example, IT system can build a more scientific, transparent, and efficient budget system to provide a timely and accurate data when senior management team make decisions in the future.
As the organizer of budgeting, I should keep learning of the professional knowledge and keep improving to achieve better. Also, much appreciation that you can continue to support my work and please let me know if your have any suggestions or comments.

Frontera Insight Department Information

Frontera Insight Department Information

There are many kinds of pest control facilities all over our Suzhou plant, such as: rodent bait stations, sticky rat boards, fly lights, cockroach houses and so on. Regularly we will check, maintain and count these facilities, Today we're going to talk about why plant's pest control facilities catch so many different kinds of pests... ....
1. Is it because our plant buildings are easy for pests to enter?
The answer is not necessarily. Some pests such as rats, mosquitoes, flies, moths, marabou, crickets, etc. are mostly bred by external greenery, stagnant water, garbage, etc. These pests will not have a particularly large deviation from the hygienic cleanliness of the factory itself, but rather, they invade indoors through a number of channels. Therefore, when our pest facilities have monitored these pests, it means that there are loopholes in the building structure or the management of doors and windows need to be improved, we will pay attention to the loopholes in the factory building, gap sealing and strengthening the management of the portals and windows, so as to cut off the invasion path of pests.
2. Is it because there are a large number of other insects in the factory buildings?
The answer is also not necessarily. The reason why spiders make webs or move around indoors is mainly to feed on insects. Therefore, when there are spiders monitored by our pest control facilities, it means that there may be an abnormality in the control of indoor flying insects/other insects, and we will have to revisit the flying insect control program.
Each pest monitored by the pest control facility has a very important guiding significance, and different pests, due to different habits, indicate different directions of prevention and control, and even the same pest, from different perspectives, will have a lot of different guiding significance, such as webbing spiders, which both suggests that we may not have good control of flying pests, and also reflects that the cleaning and sweeping of the site need to be strengthened. Through regular inspection, replacement and analysis of pest control facilities, we explore the secrets behind those pests through the ones we catch!

Story Behind Pest Control

Selina Zhu from EHS&Adimin Dept.

Frontera Insight Training Zone

Training for Interviewer
With the development of the company, more colleagues engage in interview process. On August 2nd, HR Department organized an interviewer training in Shanghai to help our interviewers improve their ability to select candidates. In 2-hour training course, through on-site explanation, case discussion, group exercises and examinations after class, the interview ability of all participants has been improved. At the same time, all of them are more aware that the interviewer's etiquette not only reflects personal image, but also represents company's professional.
In the future, we will be more professional to attract talents for Frontera.

Corporate Culture Training
"Dig, dig, dig in the garden of Frontera, plant the seeds of mission and bloom the flowers of vision", remember this song?
This is the song that HR sang in May, when HR department held corporate culture training in Suzhou and Shanghai, in order to let everyone understand the relationship between "Company Mission" and "Company Vision" more clearly.
As a gene therapy company, our mission is "To develop and produce high-quality gene therapy products that are affordable to patients", and our vision is "To be a gene therapy company integrating R&D and manufacturing, which is trusted by patients, respected by industry and recognized by society". Our mission is like a seed planted firmly in everyone's heart, guiding the direction of the company; our vision is the flower that will blossom from this seed in the future; our values are like the three elements of plant growth, which require every Frontera people to practice company's values and behaviors in daily work, and to adhere to the values of "Innovation, Efficiency,  Integrity, and Rigor".
More exciting coming soon, please look forward to!

Training Events in Summer>>

Jackie Peng from HR Dept.

Frontera Insight Department Information

1st Anniversary - CN

2nd Anniversary - CN

Houjuan Mao-Manufacturing Dept.

Xueping Qian-SCM Dept.

Juan Zhang-QC Dept.

Mark Wang-Finance Dept.

Xiaolong Tang-
QC Dept.

Edison Xia-QA Dept.

Chunhong Jiang-QC Dept.

Yolanda Zhao-EE Dept.

Emily Zhang-SCM Dept.

入职2周年-US

Justin Isaacson

Sajan Shrestha

Josh Stewart

Steven Hsu

Dianne Brennick

Chinmay Patkar

Shama Pilankar

2nd Anniversary - US

1st Anniversary - US

3rd Anniversary - US

Jiawei Tang-Manufacturing Dept.

Meng Li- 
RA and Project Management Dept.

Frontera Insight People in Frontera

Frontera Insight People in Frontera

Employee Recognition - US

Wedding News

Helen Feng, Linrui Li and Justin Isaacson (nominated by Chinmay Patkar and Yiling Fang)

Analytical Development group would like to recognize “Team JHL” for their contribution to multiple fronts in the past few months. The team has Justin, Helen and Linrui, and is led by Helen. The team focuses on LC based method development. They have worked tirelessly on several new method development projects including IEX to characterize empty/full capsid, and CE-SDS to quantify the VP1/2/3 ratio. Apart from these, they have been taking on many other tasks such as analytical testing support, NGS data analysis, critical reagents inventory and tracking, freezer/fridge inventory, pipette calibration, document management, etc. We would like to thank them for their dedication and achievements. Thank you, Team JHL!

Jeff Kan and Eric Tang (nominated by Ting Yang)

Patients safety is always number one consideration at Frontera. Generating drugs with the best quality is the priority of Process Development. In the past several months, DSP team has worked tirelessly to optimize our current downstream process. Within such short period, the team was able to identify possible path forwards, test the feasibility of the proposed methods, modify/improve the methods, transfer the methods to MFG, enhance the robustness of the methods, and help with scale up troubleshooting. With all these efforts, we can greatly reduce empty capsids in final drug product for patients’ overall wellbeing. We would like to recognize Jeff and Eric for their dedication to developing this new downstream process. With this mission to tackle as well as long request of material generation for pre-clinical studies, since they were the only two downstream members, they endured high tensity of workload during the new method development time. We thank them for their effort contributing to cleaner drug and we thank them for their hard-working spirit.

Congratulations to Michelle Martin from the AD team who was married to her longtime partner Justin on 7/29/23.

The office threw a pre-wedding celebration for the happy couple on 7/19/23 (photo attached) including the newlywed game and a personalized Bingo game.

In the presence of many colleagues from Frontera, we wish the couple a hundred years of happiness and everlasting love.

Frontera Insight People in Frontera

Frontera Insight People in Frontera

New Face in Frontera - CN

Frontera Insight People in Frontera

Welcome Luna Zhang form Finance Department、Phyllis Wu from Clinical Quality Assurance Department、Simon Zhang from Clinical Operation Department、Lin Wang form Medical Department、Hongbin Wang from BD Department、Leo Xu from EE Department to join the Frontera family!
We are looking forward to a new journey together!

New Face in Frontera - US

I'm Kyle Chamberlain, a virologist with a passion for understanding the early events of viral infection and exploring the potential of viral gene therapy. I hold two degrees: a Bachelor's in Biochemistry and a Ph.D. in Virology, both from the prestigious University of Surrey. Originally from Portsmouth, England, I moved to the US in 2015 where I lived in New York City, working at the Mount Sinai School of medicine. In 2021, I moved to Boston to begin working in industry. When I'm not in the lab, you can find me pursuing a variety of interests. I have a deep love for nature and enjoy hiking, going for walks, and kayaking. Staying active is essential to me, so I also engage in running, going to the gym, and swimming. In my leisure time, I like to relax by watching movies, dining out, reading, and exploring my creative side through painting

I am Amanda Su and I recently joined the Process Development team as an Associate Scientist. I graduated this past May from Rensselaer Polytechnic Institute with a bachelor’s degree in biomedical engineering and a minor in public health. During college, I completed internships at Ocular Therapeutix and Hologic. While I went to school in New York, I am originally from Boston and am happy to be back! After work, I go rock climbing almost every day and on weekends, I enjoy sailing or hiking with friends. I’m excited to keep meeting everyone at Frontera so feel free to reach out!

 I'm Alexis Villanueva,I graduated from Salem State University in 2021 with a Business Administration degree with a concentration in Accounting. I like to golf, travel, and spend time with my family on my free time. 

Frontera Insight People in Frontera

Onboard on 7/10

Onboard on 7/10

Onboard on 7/17

A Tour of Western Sichuan

In the list of travel destinations there must be a place called West Sichuan. Western Sichuan mainly refers to Aba Prefecture, Ganzi Prefecture, Liangshan Yi Autonomous Prefecture and other places in the western Sichuan Basin, most of belong to plateau Tibetan. Snow-capped mountains, streams, forests, meadows, and Tibetan and Qiang culture form a beautiful and mysterious corridor. Western Sichuan, a feast for the eyes, clearance to the soul. Western Sichuan, plateau, cliff, debris flow, mountain road 18 bends, high altitude, terrain ups and downs, can also be a drill before entering Tibet. 
From the city of Chengdu, along the Minjiang River, through Dujiangyan, Yingxiu and then to Balang Mountain, along the way is a beautiful scenery of canyons, bridges, flowing water, withered vines and old trees. Balang Mountain  is known for vertical changes from evergreen broad-leaved to alpine desert, so called "one mountain hides four seasons, ten miles of different climate" meteorological changes. Shuangqiao Gully is wide and flat, and there are many peaks more than 5000 meters above the sea level distributed in the gully, alpine forests, meadow flowers, mountain streams, distant snow-capped mountains, mountain clouds line, like a landscape gallery, rolling showing in front of you. 

Frontera Insight Life Sharing

My next stop is black Stone Park, the world-class geological wonder also known as "China's Bermuda". It's China's only plateau stone forest landscape, with spectacular grasslands, fantasy black stone, plateau flower sea, White Pagoda Temple and other internet hot spots, "Enjoying Gesang in spring and summer,autumn view color, winter all white", the scenery changes throughout the year, every shot you take is like postcard. Along the Mani River Valley, came to the 318 State Road,  the only load to enter Tibet.The land is endless, the scenery is beautiful, has been loved by photographers, known as the photographer's paradise. With a blink of  eyes, the "Caviar West" platform is under my foot, and the Gongga Mountain, which is 7556 meters above sea level, and the Four Girls Mountain are not far away.
With the prayer flags flying in the wind, came to the high city Litang, where the seventh and tenth Dalai Lama reincarnated, Litang Temple located here, is the first major Gelugpa (yellow religion) temple in Kang District, known as the Buddhist holy land in Kangnan. There is faith everywhere in the Tibetan and Qiang culture, The pram reed is tough as iron, the rock is never moved, and the pilgrimage of three kneels and nine kowtow is the ultimate reverence for the faith.
With the guidance of faith, I arrived at the enchanting city of “Daocheng Yading”. Daocheng Yading has the reputation of being "the last piece of pure land on the blue planet". Clear streams, green meadows, looming snow mountains, and deep blue sky, you can experience" body in hell, eyes in heaven". Close your eyes, feel the breeze from the mountain stream, a little cool from the tip of the nose, a circle of ripples, and gradually bloom to the whole cheek, arms in front of the chest, like the whole world is cool down. The ears ring the distant bell of the rotary, the body is purifying, the soul is sublimating.
In your life, please give yourself a chance to go to western Sichuan.

Yolanda from EE Dept.

Frontera Insight Life Sharing

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