Manufacturing

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.

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

Use of a small-scale filler can result in increased filling efficiency.

The choice of expression system requires wise consideration of product complexities.

CPC presents a green alternative to chromatography that supports sustainable operations.

Experts outline the benefits of single-use consumables relative to traditional approaches.

The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.

The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.

PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.

India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.

The new facility also provides a plan for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally.

Mendus and NorthX Biologics will work to develop and commercialize Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.

Charles River’s off-the-shelf lentiviral vector packaging plasmids are intended for use with cell and gene therapies.

The new excipients manufacturing facility is expected to be completed in 2025.

There are various challenges associated with the development of CAR-T therapies for solid tumor cancers.

Chris Spivey, editorial director, speaks with Sean Hart, CEO and SCO of LumaCyte, on percent transduction for AAV measured.

The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.

Webinar Date/Time: Thu, Jul 27, 2023 11:00 AM EDT