Deal-Making

The companies' collaborative biomanufacturing service looks to take flight after an unlikely airport meeting.

Deal-Making

The partnership between contract development and manufacturing organizations (CDMOs) Recipharm and Exela enables production of over 100 million units (vials and pre-filled syringes) annually.

Facilities & Capacity

A panel of experts discussed the difficulties and necessity of wide-spread adoption of cell therapy manufacturing at BioProcess International 2024 in Boston, Massachusetts.

Facilities & Capacity

The 250,000 square-foot site will house biosafety testing, analytical development, and cell-banking manufacturing services.

Global Markets

The partnership between contract development and manufacturing organizations (CDMOs) Recipharm and Exela enables production of over 100 million units (vials and pre-filled syringes) annually.

Facilities & Capacity

Swiss firm Ferring has opened a manufacturing facility in Kuopio, Finland to manufacture drug substance (DS) for its a bladder cancer gene therapy treatment.

Regulations

A President Biden Executive Order supporting homegrown biomanufacturing will remain in place whoever wins in November, White House OSTP assistant director Sarah Glaven told Biotech Week Boston delegates.

Regulations

Wei Wang, a microbiologist and inspector with the US Food and Drug Administration (FDA), said poor documentation is among the most common of CBER observations.

Therapeutic Class

A panel of experts discussed the difficulties and necessity of wide-spread adoption of cell therapy manufacturing at BioProcess International 2024 in Boston, Massachusetts.

Sponsored Content

Cryopreservation in cell therapy and gene therapy manufacturing is critical to maintaining product integrity. The components used in the production of cell and gene therapies must be able to withstand temperatures of -130°C and lower – as well as the freeze-thaw cycles associated with processing, transportation, and administration to patients. The CGT industry is moving toward applying biopharmaceutical best practices in a way that meets CGT requirements. This white paper covers key issues in CGT processing including: READ WHITE PAPER CPC set the industry standard for sterile connection technologies with its AseptiQuik® G Series. It now offers the first aseptic connector solutions designed specifically for cryopreservation in CGT applications, featuring the MicroCNX® ULT Series. CPC is the industry leader in aseptic sterile connection technology

Upstream & Downstream Processing

The 250,000 square-foot site will house biosafety testing, analytical development, and cell-banking manufacturing services.

Upstream & Downstream Processing

The Florida-based contract development and manufacturing organization (CDMO) will produce an antibody for acute lymphoblastic leukemia (ALL).