This week’s headlines include: The Next Flu Pandemic Will Appear When You Least Expect It, Sanofi/Regeneron’s ‘breakthrough’ PD-1 hits positive notes in skin cancer, GSK’s new pharma head on lookout for cancer deals to boost pipeline, Gilead, Kite to Acquire Cell Design Labs for Up-to-$567M, Growing CAR-T Footprint, Unheard of’ responses to bluebird CAR-T therapy seen in myeloma study, and StemBioSys Announces New European Distributor For Stem Cell Research Products.

In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

Novel technology enables encapsulated cell therapeutics without triggering fibrosis

In this podcast and accompanying article, we interviewed Dr. Paul Wotton, CEO, about Sigilon Therapeutics’ discovery platform. The platform combines cell engineering and biocompatible Afibromer^™ technology to enable cell therapeutics that do not trigger fibrosis…

Cool Tool – Xeno-free media supplement for Cell Therapy Manufacturing

Cell-based therapy has demonstrated significant promise in the potential to treat some of the most challenging diseases. The recent FDA approvals of Novartis’ Kymriah and Kite Pharma’s Yescarta demonstrate the tremendous benefits this industry has to offer. As more and more cell therapies progress towards commercialization, safe and efficient manufacturing becomes critically important. Because the cell is the therapy, materials and methods used to culture the cells are a key focus of regulators. It is easy to become inundated by the plethora of reagents available on the market and risk mitigation strategies are becoming differentiators. Several companies have looked to serum-free culture in an attempt to remove the variability associated with using animal source sera. However, the ex vivo manipulation necessary for Cell Therapy manufacturing creates a more challenging system for the cells to survive in and thus they have a tendency to struggle in serum free conditions. If the cells aren’t growing well, then manufacturing can’t meet the efficiency or timelines required to create a viable product…

Dissolvable microcarriers – Efficient and streamlined stem cell harvest for Cell Therapy biomanufacturing

We recently finished our Ask the Expert discussion, “Enabling Stem Cell Therapy Biomanufacturing using Dissolvable Microcarriers.” During this Ask the Expert session, we covered topics related to the large scale culture of stem cells for Cell Therapy and the use of dissolvable microcarriers as an enabling technology. Topics included general questions about the use of microcarriers in Cell Therapy manufacturing, for example, microcarrier optimization, cell aggregation when using microcarriers, and recommended scale for switching to microcarriers. In addition, we had several questions related to the use of dissolvable microcarriers that included, compatible cell types, cell attachement, cell harvest, media, bioreactor compatibility, and durability…

Development of an Improved Poloxamer 188 – Optimized for Cell Culture Performance

Poloxamer 188 is a surface-active non-ionic polymer used in cell culture media as shear protectant. With time it became a standard ingredient in cell culture media for commercial production processes. It was demonstrated to increase the robustness of mammalian cells to shear from sparging, which probably is the strongest contributor to the hydrodynamic stress in bioreactors…

Downstream Bioprocessing Cost Modeling – Looking at Integrated Continuous, Single-use and Stainless Steel Platforms

Process economics are frequently discussed with respect to continuous biomanufacturing implementation. More specifically, are the potential cost benefits worth making a manufacturing change and in which situations are the benefits greatest? At Biotech Week Boston in September, there was a very interesting talk titled “Cost modeling of the downstream bioprocessing design space,” presented by Mark Schofield, Ph.D., Senior R&D Manager, Pall Life Sciences. In the talk, Dr. Schofield shows data related to cost modeling the downstream bioprocess design space. He also describes some of the challenges facing biomanufacturing including cost pressure, competition, and the rise of biosimilars, and how implementing integrated continuous operations can address several of these challenges…

Resolving large scale buffer management challenges

In this podcast and accompanying article, we interviewed Joakim Lundvist, Modality Manager, BioProcess™ Hardware, GE Healthcare about large-scale buffer management challenges. Buffer preparation is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required. So how can this be done in a more efficient way? How can more capacity be added to buffer preparation without adding major capital investment? Are there ways to reduce the manufacturing footprint and time spent on buffers?…

Enabling Antibody-drug conjugate manufacturing using single-use systems in downstream – Extractables study demonstrates a good fit

Antibody drug conjugates offer tremendous therapeutic potential and the market for ADCs is expected to expand rapidly. However, antibody-drug conjugate manufacturing presents both technological and logistical challenges…

Protein A Chromatography – A look at where we have been and where we are going

In this podcast and accompanying article, we interviewed Jonathan Royce,  Business Leader, Chromatography Resins, GE Healthcare Life Sciences, about the evolution of Protein A including the latest developments in Protein A chromatography resins. We also discussed what the future holds for this purification mainstay and how it can continue to address the changing needs of biopharma…

Podcasts:

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Headlines:

“The Next Flu Pandemic Will Appear When You Least Expect It, The New York Times

“If a new flu pandemic emerges, it may be easy to spot. The epidemic is most likely to appear in spring or summer, researchers have found — not in the midwinter depths of the flu season. Normally flu strikes in winter, when children are crowded into classrooms and the air is cold and dry — ideal for transmitting the influenza virus. But historically, that has not been true of the great flu epidemics…”

“Sanofi/Regeneron’s ‘breakthrough’ PD-1 hits positive notes in skin cancer, Fierce Biotech

“It may be way back in the race for market share, but Sanofi and Regeneron touted new topline data for their midstage checkpoint inhibitor in a certain form of skin cancer this morning. Data out today focused on 82 patients with advanced cutaneous squamous cell carcinoma (CSCC), a form of skin cancer less deadly than melanoma…”

“GSK’s new pharma head on lookout for cancer deals to boost pipeline,” Reuters

“GlaxoSmithKline will scout for deal opportunities in cancer medicine, as well as immunology, as the drugmaker seeks to rebuild its presence in oncology, its new head of pharmaceuticals told Reuters. In his first public comments since joining GSK in September, Luke Miels said the focus would be mainly on buying or licensing early-stage drugs. The hunt is set to gather pace in the new year with the arrival of new research chief Hal Barron…”

“Gilead, Kite to Acquire Cell Design Labs for Up-to-$567M, Growing CAR-T Footprint,” Genetic Engineering News

“Gilead Sciences and its Kite Cell Therapy subsidiary have agreed to acquire Cell Design Labs for up to approximately $567 million, in a deal designed to grow the buyers’ footprint in chimeric antigen receptor T-cell (CAR-T) and other cellular therapies. Gilead and Kite said the deal will enhance their R&D efforts with new technology platforms, allowing both to speed up the development of next-generation Cell Therapy candidates…”

“Unheard of’ responses to bluebird CAR-T therapy seen in myeloma study,” Reuters

“More than half of patients with advanced multiple myeloma who had run out of therapeutic options remained in complete remission after receiving bluebird bio Inc’s experimental gene-modifying immunotherapy in a small, early stage study, according to updated data released on Sunday…”

StemBioSys Announces New European Distributor For Stem Cell Research Products

“StemBioSys Inc. announced today that it has entered into an agreement with Caltag Medsystems Ltd. to distribute and market StemBioSys products. Caltag will distribute StemBioSys products in the European Union. Initially, the agreement will cover StemBioSys’ cell expansion products, but as additional products are added to StemBioSys’ portfolio in the future, these will likely also be included in the distribution agreement, according to StemBioSys President & CEO Bob Hutchens…”