Monday, October 3, 2022 Daily Archives

Revolutionizing Cell Culture with Cryopreserved Pre-Plated Cell Monolayers

Cell monolayers are an ideal method and widely used in the discovery of new drug compounds and the study of cell biology. Until now, there was no cryopreservation technology available to store cell banks pre-plated commercially. The conventional approach of cell-based assay workflow was time- and resource-consuming. Now, the cryoprotectant technology CryoShield™ from CryoLogyx together with the controlled and scalable plate freeze-thaw platform RoSS.pFTU from Single Use Support, mark a revolution in commercial cell banking: Cryopreserved Thaw and Use Cell…

Star-spangled Gamma looks to disrupt the bioprocess space

Gamma Biosciences presented its portfolio of tech companies at Biotech Week Boston and spoke about its role as a disruptor in the consolidated bioprocess sector. “Gamma was built on this notion that advanced therapy manufacturing to date has largely been served by the biologics industry; the technologies that have been brute forced into our industry to make things work and get products to market,” Gamma Biosciences’ CTO Phil Vanek told BioProcess Insider at BPI East – part of Biotech Week…

Sartorius showcases freezing, filling, and mAb capturing tech

Bioprocess giant Sartorius launched four products at Biotech Week Boston in September 2022. Miriam Monge, head of Marketing Fluid Management Technologies, walks us through them. First on display on the floor of the Boston Convention and Exhibition Center was Sartorius’ Celsius FFT, a large-volume bulk drug substance storage and transport system. According to Monge, such an offering is unique in its scale, and as a full platform, consisting of a blast freezer, a fill and drain station, a lift, a…

Miltenyi looks to offer ‘top-to-bottom’ services as tech meets CDMO

Miltenyi Biotec says it is uniquely placed in the advanced therapy space to support developers with the full gamut of technologies and chemical/biological substances. Founded in 1989, Miltenyi has moved from a cell separation firm into a full cell and gene services firm, offering a host of services including as a contract development and manufacturing organization (CDMO). “What makes Miltenyi unique is we not only supply the expertise from both the technological, biological and even regulatory expertise, but we have…

Astrea unveils nanofiber-based lentivirus purification tech at BWB

Astrea Bioseparations developed and launched Nereus LentiHERO in just 180 days and says the nanofiber-based technology radically transforms lentivirus purification. Bioseparation products and services firm Astrea celebrated the launch of Nereus LentiHERO at Biotech Week Boston in September at a crowded booth on the show floor. The lentiviral vector (LVV) purification tech incorporates AstreAdept, the firm’s proprietary nanofiber material, which addresses the challenges associated with purifying the large and fragile products used in cell and gene therapy. Marc Hummersone, senior…

FDA creates advanced therapies ‘super office’ to meet higher demand

The US FDA office tasked with overseeing cell and gene therapies has been renamed and reorganized in response to increased submissions. The changes – details of which were published in the Federal Register last week – saw the ‘Office of Tissues and Advanced Therapies’ become the ‘Office of Therapeutic Products (OTP)’ and will be designated as a ‘super office’ that will manage its program at a macro level. The changes – which came into effect on September 16 – will…

Modular systems make facility delivery fast, says Tenaya

Scott Bertch from heart disease gene therapy developer Tenaya Therapeutics told BWB delegates modular systems have the ability to accelerate facility delivery. When thinking of gene therapies “manufacturing is one of the biggest problems,” Bertch, executive director, clinical manufacturing site head at Tenaya Therapeutics told delegates at the BPI conference, part of Biotech Week Boston 2022. While there are pros and cons associated with both inhouse and outsource manufacturing models (Tanaya has previously spoken positively about the former for cell…

With MA plant operational, CRISPR lauds allogeneic cell therapy approach

CRISPR Therapeutics says pharma must realize that an allogeneic approach is the only sustainable way of “doing cell therapies across broad populations.” While the market has seen a flurry of chimeric antigen receptor (CAR) T-cell therapy approvals –  Novartis’ Kymriah (tisagenlecleucel), Gilead’s Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel), Bristol Myer Squibb’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), J&J’s Carvykti (ciltacabtagene autoleucel) – these have all been autologous products, made by taking, reengineering, and reintroducing a patient’s own cells.…