Biopharmaceutical CMC Summit
What kind of policy dividend has been issued?
How can biopharmaceuticals win unexpectedly in the intensified industry competition?
How can pharmaceuticals enhance their innovation and industrialization in the face of challenges and opportunities?
On November 8, 2019, Biopharmaceutical CMC Summit was successfully held in Yantai, China, which is also the fourth high-level biomedical summits hosted by MabPlex.
More than 200 experts from biomedical CMC fields worldwide attended the summit and launched a brainstorming on the development of the biomedical industry and CMC strategy.
Innovation for new drugs is the only choice for biopharmaceuticals
In recent years, the Chinese government has been encouraging the innovation of new drugs with clinical value. There are a large number of breakthroughs and innovations in the policy design and regulatory system, which have released the system dividend and opened up a “reassuring pill” for innovative pharmaceutical companies. As a result, a number of innovative companies dedicated to the development of new drugs continue to emerge.
The golden age of innovative medicine has come, how to grasp the vents?
Dr. Hui Feng, COO of Shanghai Junshi Pharma, said that pharmaceutical companies should break the “non-druggability” with subversive innovation, and balance the short-term and medium-term strategy around improving research and development efficiency, finding differentiated strategies, and developing new target drugs. This is the cure for the challenge.
At the same time, the official landing of the MAH (pharmaceutical listed holder system) system also provides the possibility for biopharmaceuticals to rationally and fully utilize CDMO’s professional services in a market environment with the intensified competition.
CDMO assists supply chain collaboration
The pharmaceutical enterprises enter the “intensive cultivation” period.
“Leave the professional work to professional suppliers, the precise division of supply chain will inevitably bring about high efficiency and quality.” Dr. Wei Chen, CEO of MabPlex, made such expression to the “intensive cultivation” of enterprise development.
In the past, Chinese pharmaceutical companies usually preferred a large and comprehensive vertical model, which proved to be less efficient. On the long-term development strategy, pharmaceutical companies need to focus on what they are good at and leave the other parts to professional vendors.
CDMO can assist biopharmaceuticals to accelerate their IND and BLA with a professional technology platform, strong and flexible production capacity, familiar interpretation of pharmaceutical regulations and experienced professional team.
Dr. Li Xinfang, Senior Vice President of MabPlex, delivered a speech entitled “Time control strategy for antibody drugs development from gene sequences to IND” at the summit.
Antibody-drug development has a long timeline and high risk due to complexity. Dr. Li shared the experience of timeline and risk control of cell line construction, process development. Based on the project knowledge and experience, MabPlex can optimize the project execution plan through risk assessment, to balance the efficiency and quality, and finally reduce the timeline from 20 months to 15 months for cell line development to IND project.
Equipment innovation enables the process of innovation
If you want to do something good, you must first sharpen it.
This summit also invited several special guests in biotechnical fields to share the latest innovation and update.
Professor Ningning Ma from Shenyang Pharmaceutical University shared his experience in bioreactor and manufacturing scale-up, also the detailed “diagnosis” on how to maintain the quality stability during the process enlargement.
Professor Jun Han from Liaocheng University, also internationally well-known formulation expert put forward pertinent suggestions for the formulation development of macro-molecular drugs.
Professor Jing Jie of Binzhou Medical College also shared his active and effective exploration of fully automated cell drug preparation equipment with global patents, which is likely to grow into “Huawei” in the field of medical equipment.
Participating in international competition with innovation
In 2017, China joined the ICH (International Council for Harmonization), which means that Chinese pharmaceutical companies will participate in international competition with international pharmaceutical companies.
Innovation is the only choice for Chinese biopharmaceuticals.
“Among 100 new drugs, none of them may succeed. But if you don’t develop new drugs, you will never succeed.”
Dr. Hui Feng said that innovative biopharma should set clear goals for their future, which is differentiated competition, subversive thinking and a complete technical system for drug R&D.
Henlius (Shanghai) achieved a breakthrough and put the first biosimilar “Rituximab Injection” in China to market. Dr. Junli Zhang, senior vice president, shared the research and development process of “Rituximab Injection “. Many of the development work is conducted ahead of the regulation issuing. It is the rigorous innovation that finally won the recognition of regulatory authority and has already started registration work in more than 50 countries overseas.
After the summit, the participants visited the facility of Yantai site MabPlex. As a CDMO company, MabPlex has built two platforms for CHO high-efficiency expression and large-scale ADC production with diversified brands of bioreactors Sartorius, GE, Thermo-Fisher; As one of the few one-stop CDMO for ADC drugs, MabPlex has successfully submitted the first ADC IND in China and support 150L scale conjugation. The guests were amazed at the rapid development of MabPlex and impressed by the strong capacity and excellent team with rich project experience.
