Home to the largest population in the world and operating in a reimbursed environment, the humongous potential in the Chinese biopharmaceutical industry is impossible to ignore. But it’s also very competitive.
At BioPharma Asia Convention 2017, we’ll be joined by leaders from innovation-driven biotech and pharma companies, as they share their strategies for surviving in the competitive Chinese market. Among the panel of highly experienced speakers is Dr Claudia Lin, General Manager of Jiangsu Alphamab, China. Dr. Lin has taken some of her precious time already, to share some of her insights prior to the event in Singapore next 21-23 March 2017.
Q: How does Alphamab promotes “me-better” products in the Chinese “me-too” market?
Lin: We have supported many leading Chinese biopharmas in their biosimilar endeavors. However, for our internal product development efforts, we are now focusing on the pipeline that we have IP for, and those are mostly “Me-better”, or novel biologics. The biosimilar markets in China is getting fairly crowded, but developing “ me-better” or novel biologics requires significantly more expertise both in the design of the molecules as well as process development before we can evaluate the pre-clinical and clinical safety and efficacy.
Alphamab understands these challenges and is investing in acquiring the scientific, technical and manufacturing expertise needed to bring these exciting molecules through development, and into the market. This is why Jiangsu Alphamab was created. It will operate as a separate product development entity to the original Suzhou Alphamab, which remains to be a leading R$D company in China.
The needs and financial incentives for these (Me-better and novel biologics are very clear:
1. Safer and more effective biological products for serious medical conditions are needed, both in China and also globally;
2. We understand these unique molecules the best, so it’s best for Alphamab subsidiaries to continue the product development and commercialization work ourselves;
3. Since we aim to provide these products to the global market, our goalis committed to having GMP manufacturing and Quality management systems and operations which meet the global cGMP standards.
Q: What do you see as the most important hurdle to overcome in Chinese biomanufacturing industry?
Lin: Realizing consistent high Quality. Quality in all aspects of the biomanufacturing decisions and operations. It’s not hard to build beautiful buildings and buy top of the line equipments, but it’s much harder to ensure that all the infrastructure is built to meet high quality standards. This includes the design of production lines with global GMP requirements and your specific product needs in mind. If you get it wrong at the design stage, then your manufacturing line will be always compromised, and in some cases, never be fully qualified. The C&Q process requires tremendous understanding of the manufacturing process, including the critical product parameters that require consistent delivery by the equipment. Many companies use vendor provided IOQ packages without ensuring that they work for their specific product and process. A lot of knowhow is needed to do the qualification work right.
Another challenging aspect is the environmental monitoring program, again, it needs to be tailored to your product and process and based on quality risks. In recent years, many companies have strengthened their Quality systems. This is very encouraging. However, the system is there to help ensure product Quality and compliance. There is a misconception that as long as a quality system is in place, then the firm will be able to meet high quality standards for their products. This is overly simplistic. Ensuring high Quality needs to start with meeting compliance standards, but doesn’t stop there. Many firms don’t recognize that Quality by Design needs to be considered during process development, not wait until GMP manufacturing, because by then, you may discover that you will not be able to deliver the product with your desired Quality and the impact on the clinical pipeline will be very unwelcome.
Lastly, there is in general a lack of highly experienced Quality professionals in China, especially those with sufficient biologics product development knowledge. The shortage of these people would undoubtedly cause a lack of credibility and Quality oversight in all the manufacturing related decisions, starting from material management, ending with product distribution related quality issues, and product Quality can be compromised in so many ways in between. In summary, realizing consistent high Quality is a big challenge in China biopharma even though the country and the industry are certainly moving towards the right direction.
Q: What is the deciding factor you to choose an outsourcing partner, if any?
Lin: There are two kinds of partners we are interested in – those that will provide us with what we lack, at certain phase of the company growth, and those that will provide us with long term mutually beneficial growth. The same purposes are applied to selecting our investment partners.
Q: In your opinion, how can Chinese biomanufacturers overcome credibility issues to regain global confidence?
A: This is a big question. I am really only an expert in the biologics space so I would stay with my personal opinion, within this sector of the biopharma industry. I think the next few years will see the fruit of tremendous money and hard work invested in biologics R&D, and clinical development, and one of the common trends is to improve Quality and compliance. This will mandate that the new wave of Chinese biopharmaceutical growth is based on creating products with reliable product quality. If you don’t want to invest in building and continuously improving Quality and compliance, you will not become a winner at the end, which is having a product on the market, and being able to consistently supply the products to patients . This is particularly true for biosimilars as so many Chinese companies are competing for speed to market.
However, speed should not be the only driver in this business. The confidence of the global pharmaceutical industry towards China has suffered certain setback in recent years due to lack of consistent Quality of our pharma products, and in some cases, a clear de-prioritization of Quality under the pressure of profits and competition. The same unfortunate trend was also seen in the first wave of China Biologics endeavors on growth factors and other smaller protein products. China’s recent wave of biologics development, which are focused on more complex larger molecules, represented by monoclonal antibodies, have the opportunity to shift the future of making new medicine by having a much stronger emphasis on Quality. This is supported by government policies on drug regulations, and on encouraging global collaborations so China biomanufacturies can learn from the best in the world, while utilizing and cultivating talents within China.
Dr Claudia Lin will be speaking on “QbD and beyond- where are we now in Asia?” at BioPharma Asia Convention 2017, Singapore, 21-23 March 2017. Established as a true one-stop shop for all things biopharma, our 2017 program will be bigger than ever before, allowing you to explore innovation in clinical trials, manufacturing, supply chain, market access, partnering, pricing, vaccines & infectious diseases, antibodies, orphan drugs, biosimilars, stem cells and more.
About Alphamab Biotechnology
Alphamab Biotechnology is a privately owned Chinese company that has successfully built a unique biologics pipeline, which is composed of mostly “Me-better ” and novel molecules, as well as some biosimilars, from their proprietary discovery technology, protein engineering & process development expertise. Alphamab Biopharmaceuticalis the new spin-off company from Alphamab Biotechnology, that is devoted to product development, including manufacturing, quality, clinical development activities from IND on through clinical trials to product launch, and commercial operations for the “Me-better” and novel biologics from Alphamab & its affiliates. Products are for China and global markets, utilizing state-of-the-art biologics product development technology & Quality systems. The company is located in the beautiful city of Suzhou, in the Suzhou Industrial Park.
BioPharma Asia, taking place in Singapore from 22-23 March 2017 in Singapore, attracts over 1500 attendees annually. Topics from early R&D, clinical research, biomanufacturing, supply chain, market access, medical affairs and more are discussed extensively in the 3-day conference. Book now to join us.