Contract Manufacturing Services

Ensuring Quality in Contracted Support

February 15, 2024

This article looks at the relationship between a CDMO quality organization and the client.

How to Evaluate a CDMO’s Commitment to Quality

February 15, 2024

What do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?

Nelson Labs Creates Center of Excellence for Parenteral and Ophthalmic Drug Manufacturing

February 15, 2024

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

Biovian and 3P Biopharmaceuticals Combine to Form 3PBIOVIAN

February 05, 2024

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

KBI Biopharma and Argonaut Manufacturing Services Team Up on Drug Substance and Drug Product Manufacturing Solutions

January 24, 2024

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 Launches Off-the-Shelf Rep/Cap Plasmids for AAV Vector Manufacturing

January 17, 2024

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

WuXi AppTec Expands Peptide and API Manufacturing

January 09, 2024

The expansion will boost solid-phase peptide synthesis total reactor volume to 32,000 L.

Ultragenyx Picks Andelyn Biosciences to Manufacture Novel Gene Therapy for Sanfilippo Syndrome

December 27, 2023

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

NightHawk Biosciences Shifts into a Pure-Play Large-Molecule CDMO

December 20, 2023

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

RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

December 14, 2023

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