Cristy Botens, product manager in bioprocessing, Distek

Innovation is important, Botens began, and the focus should be on patients. Every innovation means that medicine gets to patients faster or has fewer side-effects. Recent pharmaceutical innovations include the first new Lupus treatment approved in 50 years, a gene therapy cure for inherited blindness, gene therapies for rare diseases, new chimeric antigen receptors on T cells (CAR-T) clinical trials (over 180 trials now), personalized cell therapy, and a vaccine that prevents cervical cancer.

The book, The Other Side of Innovation, by Vijay Govindarajan and Chris Trimble (1), lists three traps that can prevent innovation from happening: physical, when companies have invested in certain technologies or equipment and cannot afford fresh technology; psychological (“we can’t fail”), when they choose to stay with what originally made them successful and fail to notice or consider new ideas; and strategic, when they fail to anticipate the future.

What are the enemies of innovation? The first is budget: If you just spent a lot of money on equipment, you hold on to it instead of asking whether that equipment fits your purpose or is outdated. The second is complacency: You get into the rut of thinking that you have always done it like this and do not consider where you could be better. And the third is yourself and own self-doubt: You think, “what if it doesn’t work?” not “what if it does work and we can positively affect patients’ lives!” Failure is essential to innovation — so embrace it. Botens quoted Bill Gates: “Success is a lousy teacher. It seduces smart people into thinking they can’t lose.”

Complacency is easy but expensive in terms of decreased production, employee dissatisfaction, falling behind in safety and quality standards, and playing catch-up with leaders in your field. So surround yourself with innovators. New technology is making innovation easy. Single-use technologies are tailored toward innovators because of its low capital investment, customizable options, and “thinking outside the bag” opportunities.

Distek has been known for innovations in dissolution for over 40 years. The company owns more than 30 patents, has a new line for bioprocessing, and leads by example for quality, innovation, and customer service. Now Distek is introducing BIOne: a patent-pending liner technology that can use existing capital equipment. It is available for 2-L and 5-L glass vessels and can use existing sensors. No vessel autoclaving is necessary with the BIOne system. It is a good model for production-scale bioreactors with all the advantages of production scale single-use bioreactors (SUBs) at the development scale. You will be using the same physical vessels, and the liners produce similar results to traditional glass.

By closing the seed train and limiting open processing steps, you will gain long-term cost savings because in a fully closed system, and you can eliminate or reduce changeover in seed-laboratory space. Or make a high-density cell bank and skip the seed lab altogether. Thaw in the bag and inoculate directly into a 50-L SUB, or start smaller and inoculate into a 5-L SUB before bringing it up to full working volume.

You can mitigate risk for production by testing your process with a bag liner before switching from glass to SUBs at the pilot or commercial scale, prevent testing for deviations when you make that switch, and eliminate the need for investigations into what went wrong if a deviation’s cause was the vessel material. Practice safety first by limiting potential exposure to hazardous products, including viruses used for gene therapy. The bag liners can be disposed of safely in an incinerator.

The main challenge to making cell therapy affordable is scalability. By being able to use a bioreactor, you can postpone or eliminate big capital expenditures (such as autoclaves, multiple incubators, and so on). Distek products assist with complete scalability and make technology transfer easy.

Reference
1 Govindarajan V, Trimble C. The Other Side of Innovation. Harvard Business School Publishing, Boston, MA, 2010. ISBN: 978-1-4221-6696-3.