Based on the many forms that modern vaccines can take, their manufacturing is complicated. Unlike monoclonal antibodies (MAbs), vaccine manufacturers have no “template” platform to follow. Most vaccine producers develop their manufacturing processes from scratch, a prospect that can be challenging for small to mid-sized companies.
Bioprocessing is the key challenge in vaccine manufacturing. Without a well-developed and understood process, a manufacturer will face serious challenges in commercial production: e.g., low yields, high costs, and difficulties in meeting quality standards.
Most vaccine-related training organized by universities focuses more on general product commercialization. Until recently, no available training addressed detailed technical challenges in vaccine bioprocessing —and the demand for such training is very high.
Take China for example: Most of its ~40 vaccine producers are small to mid-sized companies with limited resources for training. Many vaccines made in China use processes from 10–20 years ago, which are challenging for productivity and quality consistency.
The vaccine market in China is transforming from an internal focus to an external one. Exporting vaccines will require Chinese companies to meet World Health Organization (WHO) requirements. As a result, the country recently joined the International Council on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). Employee training is a key element in ICH quality management systems.
A Commercial Solution
In February 2019, MilliporeSigma kicked off a project to develop a training program dedicated to vaccine bioprocessing. The company formed a global core team and extended working teams. Some 40 experts in Asia, the Americas, and Europe collaborated for nearly 18 months to finalize the course material. They borrowed from decades of historical data and knowledge across the entire organization. That resulted in a training solution with a unique combination of hands-on guidance and an eagle-eye view of technical trends. The team organized several workshops to collect feedback from vaccine manufacturers to ensure that its training would provide the actual information that they need.
The Course: A two-day classroom session is held in M Lab Collaboration Center facilities. Training also can be held elsewhere for integration into client quality systems. First launched in China, this program will roll out over time to Europe, southeast Asia, India, and South Korea.
The modular approach can be broken down into shorter training sessions or combined with other programs. It covers different vaccine types, such as viral vaccines, polysaccharides, virus-like particles, and so on. A combination of detailed technical guidance and strategic thinking makes it especially suitable for management audiences. MilliporeSigma’s global standardized training follows strict internal standard operating procedures (SOPs).
This summer I spoke with Ranjeet Patil (segment head for vaccines and gene therapies) and Miles Shi (associate director of Asia vaccine and gene therapies segment development) of MilliporeSigma about the M Lab Collaboration Center customer education program.
Why did you want to develop such a training course for vaccine bioprocessing?
Shi: The idea came to me when I was leading a vaccine process development group in my previous career. I had difficulties finding appropriate training for me and my team to build on our bioprocessing knowledge. Quite a few training programs covered either vaccines or bioprocessing, but nobody had combined them. After I joined MilliporeSigma and took the lead in the Asia–Pacific vaccine and gene therapy segment, I had the luxury to lead a team of brilliant scientists and engineers around the world, combining decades of experience inside MilliporeSigma, and finally make this happen.
Patil: Vaccines represent one of the most important industries to national health. Many countries are still in the process of developing essential vaccines to protect lives. Unlike vaccine giants, small to middle-size vaccine manufacturers are struggling to find proper training on bioprocessing knowledge. With this easy-to-implement training, we help our customers around the world to solve their toughest problems and enable them to make better, faster, safer, and cheaper vaccines.
Some other vaccine training programs are available in the industry. What is unique about this program?
Shi: Our training is highly focused on vaccine bioprocessing, and we manage to reach a good balance between broader coverage of information and enough depth into the topic.
Our training agenda starts with a good overview of vaccine history and trends, then breaks down into key technologies used in vaccine bioprocessing, such as cell culture, clarification, chromatography, tangential-flow filtration (TFF), and so on. Then on the second day, we have a key presentation about strategy for vaccine development followed by some deep discussion on important topics regarding quality and cost, such as quality by design (QbD), cost modeling, raw material risks, and so on.
Patil: Another unique feature of this training is “standardization.” The course was developed according to MilliporeSigma course development and implementation SOPs, which enables it to be plug-and-play everywhere around the world while maintaining the same training quality. This is critical for countries that need to receive this kind of training.
What are your future plans for this training program?
Shi: In 2019, we have launched the training in China, India, and Europe through our collaboration with the European Vaccine Initiative (EVI) TRANSVAC2 program. We have imminent plans to launch in South Korea, Southeast Asia, and South America. And we also have future plans to add a hands-on session to the current lecture-based training. This will make more of a connection between theory and practice and make the training more interactive.
Patil: The training is designed to be flexible with its modular concept. So it could be adapted easily into different settings. We are open for collaboration with universities and institutes to keep improving the course content.
Cheryl Scott is cofounder and senior technical editor of BioProcess International, PO Box 70, Dexter, OR 97431; 1-646-957-8879; firstname.lastname@example.org. Ranjeet Patil is MilliporeSigma’s segment head for vaccines and viral therapies, and Miles Shi is MilliporeSigma’s associate director of Asia vaccine and viral therapies segment development. The life science business of Merck KGaA, Darmstadt, Germany, operates as MilliporeSigma in the United States and Canada. M Lab is a registered trademark of Merck KAaA in Darmstadt, Germany.