Manufacturing

Jane True, vice-president of mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer, shares her perspective on how mRNA will shift commercial models in the pharmaceutical industry.

CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.

Avirmax’s new gene therapy facility in Hayward, Calif., will specialize in AAV gene therapy research and development.

Synthego has opened its new GMP-compliant RNA manufacturing facility in Redwood City, Calif., for CRISPR-enabled genomics therapeutics.

The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.

Can CDMOs apply lessons learned from the COVID-19 pandemic to improve sterile processing?

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.

The market potential of nucleic acid-based therapies have been pushed into the spotlight following the success of the COVID-19 vaccines.

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

Webinar Date/Time: Thu, Jun 1, 2023 11:00 AM EDT

The development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.

It is crucial to examine the context in which single-use waste is viewed.

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

Webinar Date/Time: Tue, May 16, 2023 11:00 AM EDT

Gregor Kawaletz, head of Oral Solid Dose Business Unit at Recipharm, discusses the immediate future of oral biologics

Avid Bioservices has launched new CGMP mammalian cell manufacturing suites at its Myford, Calif., facility.

The construction will expand Catalent’s clinical supply facility in Schorndorf, Germany.

Monil Malhotra, vice-president of Industrial Software at Emerson, discusses the growing demand for software solutions in the pharma industry.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

Michalle Adkins, director of Life Sciences Consulting at Emerson, discusses the structure of manufacturing organizations and how novel technologies may play a role in operations.

Forecyte Bio has opened a new GMP facility in Shanghai just two months after its sister site in the United States.