Uncategorized

Polyplus reagent aims to ease CGT manufacturing issues

Polyplus has added a reagent to its existing product line developed specifically to enable large-scale viral vector manufacturing. The French-biotech said the reagent has been developed to complement its existing FectoVir-AAV reagent line. “FectoVIR-AAV is a transfection reagent, hence a key component of upstream manufacturing of viral vectors used for gene therapy,” a spokesperson for Polyplus told BioProcess Insider. “FectoVIR-AAV transports plasmid DNA across the cell membrane. In gene therapy viral vector manufacturing, three plasmids are transfected at the same time…

Autologous CAR T Cell Manufacturing Using a Semiautomatic, Closed, Modular Workflow

Cell-based chimeric antigen receptor (CAR) T cell therapies have rapidly advanced in recent years, with a variety of targets in clinical research and several FDA approved products already on the market. There has been tremendous effort to make CAR T cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T cells. Cell isolation, gene editing, expansion, and cryopreservation are…

Mixed-Mode Chromatography: Optimizing Target Purity and Recovery with Buffer Additives

This webcast features: Xuemei He, PhD, R&D Manager of Chromatography Media Chemistry, Bio-Rad Laboratories New biotherapeutic constructs continue to increase in biopharmaceutical development, extending treatment options to a broad range of diseases we face today. These biopharmaceuticals include recombinant proteins, monoclonal antibodies, antibody drug conjugates, bispecifics, viruses, and virus-like particles to mention a few. A simple, straightforward approach to the production of these biomolecules is required to meet the current demand for process efficiency and economics. Innovative chromatographic methods facilitate…

Athenex adds allogeneic assets in $70m Kuur Therapeutics deal

Athenex will leverage its manufacturing capabilities and staff to support the development of Kuur’s NKT cell therapies. Biopharma firm dedicated to developing cancer treatments Athenex has acquired Kuur Therapeutics, a developer of engineered Natural Killer T (NKT) cell therapies used to treat haematological and solid malignancies. Through the acquisition Kurr could receive up to $185 million, through a $70 million upfront payment from Athenex and $115 million in development milestones. According to Athenex, it is not just financial benefit that…

Stem Cell Derived Exosome Production in Stirred-Tank Bioreactors

This webcast features: Aurélie Tacheny, Project Manager and Application Specialist, and Jorge Escobar Senior Research Scientist, Applications Lab, Eppendorf Exosomes are a population of naturally occurring, mobile, membrane-limited, 30–100 nm in diameter, extracellular vesicles containing a large number of proteins, lipids, messenger, and micro-RNAs. It was shown that they play a role in the mediation of intercellular communication, the modulation of immune-regulatory processes, tumor metabolism, and regenerative as well as degenerative processes. In recent years, there has been increasing interest…

Perfusion confusion? Cytiva launches Xcellerex system to simplify process

The Xcellerex Automated Perfusion System (APS) simplifies processes and reduces risk when intensifying upstream operations, Cytiva says. We speak with Andreas Castan, strategic technology partnerships leader, to find out why. Bioprocess Insider (BPI): How common is cell cultivation using perfusion? Andreas Castan (AC): There are a number of perfusion-based products on the market, especially unstable proteins like coagulation factors (e.g. Factor VIII), but also mAbs (e.g. Infliximab). Some of these have been around for 20 years or more. The use…

Thermo and Lyell team to boost T-cell fitness for CAR-T

Thermo Fisher Scientific will develop manufacturing processes for cancer cell therapies in collaboration with Lyell Immunopharma. The deal – financial terms of which were not provided – will focus on improving the “fitness” of T cells from which cell therapies are produced according to the firms. A T-cells metabolic “fitness” describes the likelihood it can be turned into a cell therapy. Cell therapies need to be fit because of the high metabolic demands of tumor cells can negatively impact their…

MolMed latest add-on for expansion hungry AGC Biologics

AGC Biologics has acquired Molecular Medicine (MolMed), increasing its presence in the CDMO space and adding a pipeline of cell and gene therapy candidates. In March, contract development and manufacturing organization (CDMO) AGC Biologics launched a voluntary tender offer to acquire Italian cell and gene therapy developer and manufacturer MolMed for €240 million ($284 million). Today the deal has been completed, bulking out AGC’s biopharma offering. On the services side, AGC adds two GMP sites in Milan and Bresso, both…

Cyclic Cell Harvest with CONTIBAC® SU Filters

As the Biotech industry is moving towards single-use components, larger batch volumes and higher cell concentrations, conventional cell harvest technologies reach their limit. Depth filters, for instance, can only cope with the increasing demands by stacking more filter elements and therefore increasing the footprint and their economic burden. Hence, innovative solutions are needed to keep pushing the boundaries of the biologics production. The CONTIBAC® SU filter of DrM excels where existing technologies crumble. Unlike in any competing technology, the filtration…

Rapid Micro Biosystems to fund EU facility construction with $120m fundraising

US sterility testing tech firm Rapid Micro Biosystems will build a European plant and expand its business with $120 million raised this week. The Lowell, Massachusetts firm – which makes automated microbial detection systems – completed a $120 million financing round this week, attracting equity investment from The Ally Bridge Group, Endeavour Vision, and existing investors including Asahi Kasei. CEO Robert Spignesi told Bioprocess Insider the firm’s “growth plan includes establishing new manufacturing capacity, beyond our current US manufacturing facility…