Manufacturing

The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance.

The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.

Webinar Date/Time: Thu, Sep 14, 2023 11:00 AM EDT

Webinar Date/Time: Tue, Sep 26, 2023 11:00 AM EDT

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.

In this episode of Drug Digest, editors discuss what happens in the manufacturing space from a CDMO and a cell/gene therapy perspective.

Stable producer cell lines show real promise despite continued development challenges.

Webinar Date/Time: Wed, Sep 27, 2023 11:00 AM EDT

Under a manufacturing agreement, Northway Biotech will develop a manufacturing process for iTolerance’s fusion protein in development for regenerative therapy.

Kiefel’s new machine is designed to form, fill, and seal up to 6,000 infusion, parenteral nutrition, or dialysis bags per hour.

Burgeoning CGT modalities bring promise and challenges.

Scale-up strategies for cell culture will require a deep understanding of overall bioprocess workflows.

Sourcing of donor cells, access to fit-for-purpose reagents and manufacturing systems, and scalability are top issues.

A proposed database includes key information about critical drugs, such as the country of origin and quantity, so supply chain weaknesses can be identified.

mRNA may be a modality whose chief advances are yet to come.

The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.

The expansion project is aimed to be completed in December 2024 and the new facility will be fully operational by 2025.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.

German manufacturer metabion is conducting a multi-million euro expansion of its oligonucleotide manufacturing capacity in Munich East.

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

Exploring new fields can bring novel antibody candidates to the pipeline.

Camena Bioscience has completed $10 million in Series A financing on the back of growing demand for DNA synthesis.

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.