News

New Cell Factory Box Launched by ProPharma and PBL for Automated CGT Manufacturing

May 07, 2024

ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.

Poseida Therapeutics and Astellas to Develop Novel Allogeneic Cell Therapies

May 07, 2024

The two companies will combine their cell therapy platforms to develop convertibleCAR programs targeting solid tumors.

US Federal Trade Commission Seeks Additional Information on Novo Nordisk Parent-Catalent Deal

May 06, 2024

The request for more information was received weeks after an application to the FTC was refiled to approve the deal.

New FDA Draft Guidance Made Available for Materials Used in Manufacturing CGTs and Tissue-Engineered Therapeutics

May 04, 2024

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Cormica Announces Seven-Figure Acquisition of TPM Laboratories

May 03, 2024

Cormica’s first US Acquisition is intended to support to organic growth of TPM laboratories.

Santander UK Grants £30 Million Loan Package to Ennogen Healthcare

May 03, 2024

The loan is intended to support Ennogen’s growth as it looks to international acquisitions.

Meeting Upstream Bioprocessing Challenges with Innovative Engineering Design (INTERPHEX 2024)

May 02, 2024

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

CDER Releases Office of New Drugs 2023 Annual Report

May 02, 2024

The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.

New FDA Draft Guidance Issued for Sponsors of Allogeneic Cell-Based Medical Products.

May 02, 2024

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

Adare Expands High Potency Handling Capabilities in US and Europe

May 01, 2024

The CDMO plans to expand and upgrade its Philadelphia, Ohio, and Milan facilities to meet the continued growth in demand for high potency handling capabilities.