Monday, April 19, 2021 Daily Archives

April 2021: From the Editor

I write this the day after US President Joe Biden’s address reporting his administration’s progress on COVID-19. Vaccines and their distribution and delivery are priorities, of course, and the companies working on them over the past year deservedly have received a great deal of attention. But our pandemic response rests on three other important pillars as well: prevention of exposure through masking and social distancing (as the President reminded us), testing and tracing with diagnostics and data, and treatment of…

Catalent adds cryogenic capabilities at Philadelphia facility

CDMO Catalent has invested to expand cryogenic capabilities at its clinical supply services facility in Philadelphia to meet cell and gene therapy demand. The contract development manufacturing organization (CDMO) did not disclose any financial details of the investment. However, a spokesperson for Catalent told BioProcess Insider “In addition to the equipment necessary to handle, package and label cryogenic materials, Catalent will add five cryogenic freezers with enough capacity for tens of thousands of vials at very low temperatures of around…

CDMO round-up: News from Lonza, MedPacto and Revolo Biotherapeutics

Lonza collaborates with Immunitas to develop candidate; MedPacto signs agreement with Samsung Biologics; Revolo Biotherapeutics chooses CordenPharma to manufacture its peptide and immune system resetting drug candidate. Great to have you here for Bioprocess Insider’s CDMO round-up. First up in our contract development manufacturing organization (CDMO) round-up is Lonza, which recently entered an agreement with Immunitas Therapeutics to support manufacturing of Immunitas’ lead program, IMT-009. IMT-099 is a monoclonal antibody that suppresses NK cells and T cells in the tumor microenvironment and…

Preparation key to gene therapy commercialization, MilliporeSigma

Gene therapy firms are under pressure to get to market quickly according to an expert from MilliporeSigma, who says process development and tech transfer are significant hurdles. The ability to treat – or cure – disease at the genetic level in a targeted manner is an attractive proposition for drug companies. The challenge now is to make these therapies in a cost and time efficient manner according to Ratish Krishnan, associate director for cell and gene therapy bioprocessing at Milliporesigma.…

Tenaya talks advantages of inhouse capabilities for CGT firms

Having internal AAV capabilities gives Tenaya Therapeutics control over its processes, timelines, and costs, but CEO Faraz Ali says it will also likely use third-party manufacturers as pipelines progress. Fresh from a $106 million Series C funding, South San Francisco-based cell and gene therapy firm Tenaya Therapeutics is establishing a dedicated facility for AAV (adeno-associated virus) manufacturing to support its emerging portfolio of gene therapy products. “We have leased a 94,000 square-foot space for our new cGMP facility, and we…

Thermo Fisher to buy PPD to build in ‘high growth’ clinical services sector

Thermo says buying PPD will position it as leader in the “high growth†CRO sector and help it win more business from new and existing customers. Thermo Fisher Scientific announced its intention to buy contract research organization (CRO) PPD for $17.4 billion in a statement on Thursday, citing demand from pharma and biotechnology sector customers. Thermo Fisher’s CEO Marc Casper said “The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers…