Friday, February 12, 2021 Daily Archives

Recipharm expands biologics offerings at German plant

CDMO Recipharm has extended its drug product manufacturing license to include immunology products, expanding its biologics offering. The license applies to the firm’s facility in Wasserburg, Germany. It covers microbiological testing which allows Recipharm to carry out bacterial endotoxin testing on its customers’ products. “Certain bacteria (gram negative bacteria) can release constituents of their cell membrane,†general manager of Recipharm’s facility, Michael Isele told BioProcess Insider. “Bacterial endotoxins can only be destroyed by dry heat exceeding 300°C. Constituents of drug…

Vigene upping viral vector capacity by 50% through Maryland facility

CDMO Vigene Biosciences has leased a 52,000 square foot facility in Maryland to support ongoing demand for viral vectors. The contract development and manufacturing organization (CDMO) has entered a lease agreement, adding a facility in Rockville, Maryland with supporting infrastructure, including HVAC and flooring and Water for injection (WFI) system in place The additional manufacturing space will complement Vigene’s nearby GMP manufacturing plant, acquired in 2016 through the purchase of assets from Omnia Biologics. The lease brings Vigene’s total lab…

Orchard Therapeutics talks the benefits of HSC therapy

Having raised $150 million, Orchard hopes to expand its therapy pipeline into larger indications and says its HSC approach is not limited to the vector it uses. The firm has said the funding will also aid the launch of gene therapy Libmeldy in Europe. Last year, the firm received approval for the one-time treatment which is used to treat children with metachromatic leukodystrophy (MLD). Though often viewed as a single technology, the delivery mechanism, the vector, and the type of…