Moderator Doug Miller, with Tim Kelly, Daniella Kranjac, Andy Ramelmeier, and Ran Zheng This part of the BPI Theater program focused on emerging bioprocess technologies and their implications for cell and gene therapy (CGT) products. Doug Miller assembled a panel showcasing a wide range of technical expertise and representing several CGT industry stakeholders. That pluralism yielded far-reaching discussions about what CGT capabilities exist, what advances could facilitate therapy manufacture, and how companies might pursue technological development. Viral-Vector Therapies Miller kicked…
BPI Theater
Breaking Through the Noise – An Approach to Differentiating Your Business
In this presentation to the BPI Theater at BIO on Wednesday, 5 June 2019, Kiran Chin introduced MKA Insights, a new firm focused on helping bioprocess, life science, clinical diagnostics, and gene therapy companies accelerate their growth. Although there’s no shortage of information on data processes, Chin has found that many companies neglect fundamentals that drive commercialization strategies. Many executives dive in without asking basic questions — ones that Chin brings to the fore: Why do we exist? What are…
DNA Encoded Library Platform at WuXi AppTec
On Wednesday, 5 June 2019, Letian Kuai delivered a presentation to the BPI Theater at BIO about the role of machine learning in drug design. In many cases, Kuai said, drugs are developed by accident. Researchers are beginning to leverage artificial intelligence to make those accidents occur more quickly and predictably. To that end, WuXi has developed a DNA encoded library (DEL) platform based on combinatorial chemistry principles and bolstered by artificial intelligence. This technology, Kuai suggests, could enable unprecedented…
China Biopharmaceuticals: Increasing In-Bound and Out-Bound Investments
Eric Langer, President of BioPlan Associates, joined the BPI Theater at BIO on Wednesday, 5 July 2019, to report recent movements in China’s biopharmaceutical markets. In collaboration with the Society for Industrial Microbiology (SIM) and 102 different authors from around the world, BioPlan conducted a peer-reviewed analysis of the factors driving product development in China. Results showed that market data are not the biggest factor; it is the high incidence of cancer diagnosis and death. Considering this great need and…
A Start-Up Sourcebook: How to Jump Five Unforeseen Hurdles to Biotech Success
The purpose of this panel discussion, which concluded the Tuesday BPI Theater sessions at BIO, was to introduce a new eBook, How to Jump Five Unforeseen Hurdles in Biotech Success, edited by Lisa LaMotta. Other contributors to the eBook — Ramani Varanasi (X-Biotix Therapeutics), Chris Haskell (Bayer Healthcare), Dan Geffken (Danforth Advisors), Luba Greenwood (Google’s Verily), Ailis Tweed-Kent (Cocoon Biotech), and Teresa Lavoie (Fish & Richardson) — joined LaMotta on this panel to explore ways of building an intellectual property…
Gene Therapy Product Analytics: Where Historical and Modern Techniques Meet
On Tuesday, 4 June 2019, Andy Topping, chief scientific officer of FUJIFILM Diosynth Technologies, spoke to the BPI Theater at BIO about analytical methods for viruses and gene therapy products. Effective analysis, he argued, requires methods from both classic and contemporary virology, as well as means that have long been used for more traditional biologic products. Even basic questions about a gene therapy product — about how much product you have made, how many vials have been filled, and what…
Standardized Plasmids for Viral Vector Production
In this Tuesday, 4 June 2019, presentation at the BPI Theater at BIO, James Brown, vice president of corporate development at Aldevron, chronicled the development of his firm’s off-the-shelf plasmid products. Offering examples of the key partnerships that Aldevron has forged in the industry, including its collaboration with Asklepios BioPharmaceutical in producing the PLDX80 proprietary helper plasmid, Brown explained how Aldevron’s standardized plasmids can help companies to produce the viral vectors needed for novel gene therapies.
Sartorius’s Bioanalytics Seeing High Return from Cambridge Biotech
To conclude day one of the BPI Theater at BIO (Tuesday, 4 June 2019), Maurice Phelan, head of cell line and testing solutions at Sartorius Stedim Biotech’s Cambridge (US) site, spoke with Bioprocess Insider’s Dan Stanton to discuss the necessity of third-party analytics, quality control (QC), and characterization. He explained how Sartorius grew into the space through the acquisitions of European service firms Cellca and BioOutsource, and the firm’s decision to consolidate the services in Cambridge, Massachusetts, to be on…
GE Healthcare Working to Overcome Advanced Therapy Manufacturing Difficulties
Catarina Flyborg, general manager of cell and gene therapy business at GE Healthcare, told the BPI Theater at BIO (Tuesday, 4 June 2019) how confidence in advanced therapies sparked by a string of approvals is driving interest in the space. Now the challenge lies in tuning the manufacture of the hundreds of products moving through the clinic. By leveraging its experience in the bioprocess space and through mergers and acquisitions (M&A) and partnerships, GE Healthcare is actively addressing issues including…
Celonic Takes the Plunge into Cell and Gene Therapies
Celonic CEO Konstantin Matentzoglu spoke to Dan Stanton at the BPI Theater at BIO (Tuesday, 4 June 2019) about the state of the biologics contract development manufacturing organization (CDMO) industry and his company’s ambition in the space. He divulged details of the firm’s recent €50 million ($56 million) expansion at its Heidelberg, Germany site, adding 4,500 square meters of cleanroom space to feed the increased demand for biologics manufacturing services, and spoke of a similar investment at a site in…