Understanding Product and Process Development in China and Achieving Commercial Viability for ATMPs
For this Event Report, the Phacilitate Team reflects on some of the key issues discussed surrounding ATMP product development in China from a roundtable hosted by Porton Biologics at Advanced Therapies Connect in September 2021.
Bringing together members of the global Porton Advanced team, the Advanced Therapies Connect roundtable featured a presentation and discussion focussed on common issues and opportunities in supply chain, import and export, commercial viability, and product and process development in China as well as other hubs of the global pharmaceutical industry.
Supply Chains for Advanced Therapy Products
It is important to focus on mapping as smooth a transition as possible from early development through to humans and commercial. To this end, the Porton Advanced team focuses on being able to freeze a process the moment it is identified as commercially viable; doing any less risks expensive and dangerous alterations to poorer processes at later stages, such as clinical development.
Scalability matters, and it should be high on your list to have clarity on what that means for your product, process, and niche. To help with regulatory authorities, it is beneficial to also bring in a healthy appreciation for analytical development.
Safety and IP in China
China demonstrates commendable IP protection and technology in its pharmaceutical sector. Coming from the West, the team has witnessed an abundance of skillset across the professional pharmaceutical population, with engineers and manufacturers’ technical teams demonstrating competency comparable to other major regions in the global industry.
Understanding Import and Export
In most cases, import and export in China for pharmaceutical purposes is permitted without issue. Bringing in viral vectors, DNA, and other material, for example, can be smooth.
One restriction that can be navigated is the export of Chinese-origin genetic material. While this can be performed, this is required to be handled via a company on an approved government list, one of which Porton Advanced works with.
Globally, delays of as much as 12–18 months are common in the industry. This is understandably due in the main to complications caused by the availability of consumables/materials, shipping logistics and equipment, much of which is shared with vaccine development and manufacture for COVID-19.
Improving Product Quality
It is always challenging to maintain accuracy, particularly where large-volume processing is concerned. Real-time analytics prove valuable here, helping to improve accuracy via continuous monitoring. This goes hand-in-hand with improvements to fill and finish, and the storing of products at higher temperatures to better enable commercial viability.
Changes in the Global Industry
When discussing the merits of global and local models, it is important to pay mind to the fact that development and manufacturing capability has shifted in recent years. In 2021, we are seeing a strong rise in the quality and scale of pharmaceutical work in Europe, the USA and China. All three are critical and influential.
In terms of serving markets overseas from a Chinese production base, it is entirely possible with the modern capability found across the country. The largest monoclonal antibody production facilities, for example, are in China, and cell and gene therapy work is well suited to regulations in the country.
About Porton Advanced
Porton Advanced is a leading research, development and manufacturing organisation offering flexible solutions to accelerate the delivery of advanced therapies.
Leveraging extensive expertise and experience across plasmid, lentivirus and AAV components for all cell and gene therapy applications, Porton Advanced optimises development and manufacturing according to the needs of each individual customer.
To find out more, contact the team at BD.SZ@portonbio.com
This feature was produced in partnership with Porton Advanced Solutions.