Cell Therapies

Outsourcing and Biomanufacturing Challenges for Emerging Therapies: A Roundtable Discussion at BIO 2016’s BPI Theater

The biopharmaceutical industry is increasingly interested in a range of emerging therapies. “We’re really starting to get beyond the monoclonal antibody,” said Patricia Seymour (senior consultant with BioProcess Technology Consultants) in her introduction to a lunchtime BPI Theater roundtable at the 2016 Biotechnology Industry Organization annual convention in San Francisco, CA, this past June. The discussion brought together three industry insiders for strategic outsourcing to talk about emerging biotherapies and their manufacturing challenges: Mark Angelino (senior vice president of pharmaceutical…

Contract Manufacturing of Cell Therapies: A Conversation with MaSTherCell’s Eric Mathieu and Thibault Jonckheere

The work of developing advanced medical products is spreading around the globe, and with it comes specialized contract services. Far from a “one size fits all” approach to development, and with few platform technologies yet available, contract service providers in the advanced therapeutics space must focus on helping to move promising science into good manufacturing practice (GMP) environments, but with regulatory pathways and eventual harmonization still under development. One company that formed to address the specific needs of cell therapy…

Bioreactor Manufacturing Platforms for Cell Therapies

As an increasing number of cell therapies move into late-phase trials, developers are considering innovative solutions to address scale-up and commercialization challenges. Many of their questions focus on the technologies and engineering strategies that will be needed to optimize their processes, especially bioreactors. At the January 2016 Phacilitate Cell and Gene Therapy World conference, Siddharth Gupta, a scientist at Lonza (Walkersville, MD), talked about the effects of upstream process decisions on product quality in his presentation “Bioreactor Manufacturing Platforms: So…

Factories of the Future: Can Patient-Specific Cell Therapies Get There from Here?

In many ways, patient-specific cell therapies (PSCTs) are still the “new kid on the block” in medicine. Researchers, therapeutic developers, manufacturers, regulators, and payers are still exploring and developing an understanding of the powerful benefits and unique challenges associated with this growing industry. As we all become more familiar with PSCTs, an evolution will need to occur — as it has for automobiles, computers, and every technological advance in human history — for these therapies to become widely adopted, cost-efficient,…

Emerging Platform Bioprocesses for Viral Vectors and Gene Therapies

Recent advances in molecular biology are expediting genomic sequencing to underpin precision medicine. Such progress is positioning gene and gene-modified cell therapy on the cusp of an extraordinary revolution in patient care for presently unmet medical needs — and a new therapeutic class that could rival monoclonal antibodies (MAbs) in importance. However, despite substantial strides made in clinical trials, the bioprocessing community is struggling to fulfill growing demands for biomanufacturing capacity to make gene and gene-modified cell therapies — including…

Cancer Immunotherapies: Fulfilling the Promise of Protein and Cell Therapies

With few exceptions, both small-molecule and biological cancer treatments have contributed only incrementally towards achieving long-term responses or outright cures. In this regard, emerging cell- and protein-based cancer immunotherapies represent game-changing strategies for treating even refractory cancer. With long-term responses now possible, medical science may be on the verge of delivering on the long-unfulfilled promise of making cancer a manageable disease. But impediments to commercializing cancer immunotherapies are substantial. Producing cell-based treatments entails substantial hands-on manipulation and perfecting the logistics…

Automation in Cell Therapy Manufacturing

The concept of automation conjures up images of robots on assembly lines or perhaps automobiles replacing horse-drawn carriages. In both examples, automation provides an ability to work tirelessly, with reproducible high-quality outputs at increased speed. For cell therapy, automation can be used to increase the scale of cell culture operations (e.g., bioreactors replacing flasks) and allow the use of closed systems that can protect cell products from contamination with adventitious agents from the environment or operators themselves. Closed systems also…

Automation of CAR-T Cell Adoptive Immunotherapy Bioprocessing: Technology Opportunities to Debottleneck Manufacturing

Continued clinical efficacy demonstrations of cell-based immunotherapies (iTx) such as chimeric antigen receptor T cell (CAR-T) therapies has made the prospect increasingly likely of an immunotherapy product achieving conditional market authorization in the short term. For example, Novartis and the University of Pennsylvania’s lead candidate (CTL019) for treating a range of hematological malignancies received breakthrough status from the US Food and Drug Administration (FDA) in 2014, permitting access to an expedited drug development pathway for high unmet medical needs (1).…

Development of a Novel Cell-Separation Platform: Discussion with Quad Technologies CEO Sean Kevlahan

Releasing and separating cells from surfaces and capture molecules are critical steps in cell therapy development. Research into such therapies as chimeric antigen receptor T cells (CAR-T) cancer therapies and stem-cell regenerative medicines demand the isolation and purification of viable and functional target cells. A number of cell-separation strategies can be used to produce such cells, but they are not able to deliver the required efficiency or scalability and can also cause damage to cells or affect their phenotype. Since…

Therapeutic Gene Editing: Tools to Facilitate Basic Science or Stimuli for a Paradigm Shift in Biomanufacturing?

Historically, fundamental science and process engineering were separated by distinct vernaculars and a decade or more in the translation pathway of candidate therapeutics from laboratory to bedside (1). This crude metric holds true for the origins of the modern pharmaceutical industry, namely fine chemicals that supported the high-margin small molecules that constitute the majority of the pharmacopoeia even today. But as illustrated by deeply interwoven careers, companies, and technologies — including those related to monoclonal antibodies (MAbs) — that classic…