Author Archives: BPI Staff

Is your cell and gene therapy manufacturing at risk for SARS-CoV-2?

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New US FDA guidance recommends evaluating process and product for transmission potential.  Though respiratory viruses such as SARS-CoV-2 are not known to be transmitted by implantation, transplantation, infusion, or transfer – i.e., the common route of administration for cellular and gene therapies – there is much about the novel coronavirus that is unclear. We do know, however, that SARS-CoV-2 has been shown to infect and replicate in cells commonly used in vector production. For developers of cellular and gene therapies that use vector delivery, this…

May 4, 2021

Cytovia driving CAR NK manufacturing to Puerto Rico

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Cytovia Therapeutics will set up a facility in Aguadilla, Puerto Rico to support production of its off-the-shelf iPSC-derived CAR NK therapeutics. Cell therapy developer Cytovia has signed a long-term joint collaboration manufacturing and operations agreement with BioSciencesCorp to integrate Cytovia’s manufacturing processes within an existing 95,000 square-foot facility. The plant, which will include more than 40,000 square feet of cleanroom and biomanufacturing space, will be located in Aguadilla, Puerto Rico, and the firm says it will recruit manufacturing personnel beginning…

March 22, 2021

Process intensification and PAT essential for achieving real-time release

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Development of complex methods enabling real-time release of therapeutics requires creativity and collaboration, say experts from NIIMBL and SCIEX. Interest in real-time release (RTR) is driving the industry to think about process intensification in a coordinated manner. Process intensification offers the potential for increased efficiencies and thereby reduced cost and time for drug production. Workflows, capital and operating expenses, product quality, and waste production can all be positively impacted. There is consequently a push in the industry to develop and…

February 24, 2021

Filling in its drug product offering: Cytiva buys Vanrx Pharmasystems

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Cytiva’s first acquisition since being acquired by Danaher sees it add robotic aseptic filling machines to its bioprocess offering. Vanrx Pharmasystems, and all 120 staff, will be incorporated into Cytiva, after the bioprocess vendor acquired the Canadian company for an undisclosed fee. Vanrx makes standardized aseptic filling technologies for filling vials, syringes, and cartridges, including its SA25 range of aseptic and lyophilized technologies, and the Microcell Vial Filler – a closed robotic isolator for pharmaceutical vial filling. “For now, this…

February 1, 2021

Astrea licenses Avacta’s Affimer reagent technology

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Gamma Biosciences’ bioseparation business Astrea will use the Affimer technology to expand its range of ligand discovery and development capabilities. Avacta Group’s Affimer reagents are small proteins that have a binding surface that can be tailored to capture a target molecule of interest out of complex mixtures encountered in biomanufacturing. “The Affimer reagent technology was originally developed at the MRC Cancer Unit in Cambridge UK for proteomics applications and was acquired by Avacta in 2012,†Alastair Smith, CEO of Avacta…

January 25, 2021

Sanofi shells out $1.1bn for immunology MAb maker Kymab

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Sanofi will gain global rights to KY1005 and a monoclonal antibody discovery and development platform through the addition of Kymab. French pharma giant Sanofi is paying $1.1 billion upfront for Cambridge, UK-based biotech Kymab with a further $350 million depending on potential milestones. The deal brings the fully humanized monoclonal antibody KY1005 to Sanofi’s pipeline, along with four other early clinical and preclinical candidates. According to the firm, the candidate targets immune system regulator OX40-Ligand, “blocking inappropriate activation and proliferation…

January 11, 2021

The next frontier of CAR-T cell therapies: Allogeneic workflows

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The development of CAR-T cell therapies provides treatment options for some of the most vulnerable cancer patients, giving them a fighting chance to battle their diagnoses if they’re eligible. Researchers and organizations continue to work diligently to optimize the manufacturing process to develop safe and effective CAR-T cell therapies as efficiently as possible, with the hope that one day they can be manufactured at a lower cost and made available to any patient who could benefit from them. Personalized therapies…

January 5, 2021

Natural killer deal: Sanofi buying Kiadis for $358m

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Once the deal goes through, the French pharma giant will add an allogeneic natural killer (NK) cell therapy platform to its immune-oncology capabilities. In cell therapy development, industry has seen some success with T-cells, most notably in the approvals of the chimeric antigen receptor T-cell therapies Kymriah and Yescarta. T cells work by spurring patients’ adaptive immune system, which learns to remember threats and eliminates them when they return. However, NK cells, which are part of our innate immune system,…

November 2, 2020

Podcast: The impact of COVID-19 on the pharma and bio supply chain

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Bioprocess Insider editor Dan Stanton joins an industry panel to discuss supply chain concerns stemming from the ongoing coronavirus crisis. Listen to the podcast now. Brought to you by international pharmaceutical content, digital and design agency ramarketing, the Molecule to Market podcast takes a listen to the contract outsourcing space with industry insights direct from the brains of the people that make the headlines. In this special episode, one of the headline writers – Bioprocess Insider founder and editor Dan…

October 26, 2020