Outsourcing

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

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?

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

Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

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.

The acquisition will give Novartis full rights to CALY-002, Calypso’s lead product candidate.

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

According to the Pharmapack Europe 2024 survey results, contract packaging will see growth over the coming 12 months.

Designers adopt value-added features, different materials, and enhanced coding technologies.

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.

The rising complexity of clinical research protocols has necessarily expanded the CRO landscape.

MilliporeSigma has expanded its biosafety testing laboratories in Shanghai, China, with the completion of new lab space at its new €29 million (US$43 million) Biologics Testing Center.

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.

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

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

A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.

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

Cambrex has completed the expansion of its North Carolina facility, doubling its manufacturing capacity.

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

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.