Contract Manufacturing, Biopharmaceutical Production

Lonza signed a long-term supply agreement to manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

Rentschler Biopharma has expanded its service offerings at its Stevenage, UK, site with a new lentiviral vector manufacturing toolbox.

The addition of BIOVECTRA’s biologics capabilities to accelerate drug development and manufacturing will allow Agilent to expand its end-to-end offerings for biopharma services.

PluriCDMO, Pluri's newly launched CDMO division, has been selected by Kadimastem to manufacture two novel cell therapy product candidates.

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product.

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.

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

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

Under a collaboration agreement, Lonza will manufacture sabirnetug, Acumen Pharmaceuticals' mAb in clinical development for treating Alzheimer’s disease.

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

In a new manufacturing pact, Chime Biologics will produce DT-7012, Domain Therapeutics' antibody candidate for treating cancer that will soon be entering Phase I studies.

The Cell Shuttle platform will manufacture cell therapies for its first clinical trials by the end of the year.

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.

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

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.

Consistent growth in outsourced biomanufacturing points to an evolving industry increasingly reliant on external capacity and expertise.

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.

Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.

WuXi XDC will provide end-to-end services to support Boostimmune’s discovery of novel bioconjugates.

More than a third of CMOs are struggling to keep skilled technical and production staff.