Contract Manufacturing, Biopharmaceutical Production

The Mirus Bio acquisition will boost Merck KGaA’s viral vector manufacturing services.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

Contract manufacturer SK pharmteco will manufacture as well as conduct testing and release of Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy for bladder cancer.

Lonza has made a deal with Acumen Pharmaceuticals to manufacture sabirnetug, a mAb that will soon be entering Phase II development for treating Alzheimer’s disease.

Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) marks the first gene therapy approved in the US for treating children with metachromatic leukodystrophy.

Under a new agreement, Chime Biologics will manufacture Domain Therapeutics’ antibody cancer immunotherapy candidate, DT-7012.

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.

The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.

Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.

Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.

Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.

Following the divestiture of its Elusys subsidiary and other non-core assets, NightHawk Biosciences will transform into a pure-play large-molecule CDMO.

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

PharmTech Europe discusses technology that enables the “democratization” of mRNA manufacturing with Scott Ripley, general manager, Nucleic Acid Therapeutics and Precision Nanosystems, Cytiva, at the 11th International mRNA Health Conference in Berlin, Germany.

Demand for efficient tech transfer, as well as compliant on-time delivery, is rising.

CDMOs are actively exploring and leveraging both new and existing technologies to streamline the cell-line development process at every step.

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.

As part of a $30 million investment, Aragen is setting up a new biologics manufacturing facility in Bangalore, India.

A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.

Under an expanded agreement, Cellares will provide proof-of-concept manufacturing for a second CAR-T cell therapy from Bristol Myers Squibb.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.

Plasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.