
FDA's Quality Management Maturity Program: Why Should CDMOs Adhere to the New CDER's Rating System?
Webinar Date/Time: Wed, Sep 27, 2023 11:00 AM EDT

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.

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.