Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

Lonza has signed a five-year services agreement to provide for the development and manufacturing of biologics and small molecules for portfolio companies owned by Bioqube Ventures.

Leucid Bio will collaborate with Lonza to use Lonza’s Cocoon Platform for clinical and commercial manufacturing of CAR T cells for Leucid’s lead candidate.

Sanofi’s acquisition of Origimm Biotechnology will add to its pipeline of vaccine candidates for treating acne.

A new Cytiva FlexFactory platform will be installed at Taiyo Pharma Tech’s site in Osaka, Japan.

Pfizer found that two-dose recipients exhibited a more than 25-fold reduction in neutralization titers against Omicron relative to wild-type.

Doer Biologics will use Lonza’s XS technology in the production of its proprietary platform technology.

Fujifilm’s new cell culture media manufacturing facility in the Netherlands has officially opened.

The additions to Crown Bioscience’s UK facility will increase and expand the company’s current in-vivo offering.

AstraZeneca struck a deal worth up to more than $3.5 billion with Ionis Pharmaceuticals for the rights to develop and commercialize their transthyretin (TTR) amyloidosis treatment.

Longeveron’s Lomacel-B received an Orphan Drug Designation for the treatment of Hypoplastic Left Heart Syndrome.

Annad Padmanabhan and Maggie Thomasson will fill key roles at Salubrent’s new cGMP analytical laboratory in Kannapolis, NC.

President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

Recordati’s blockbuster acquisition of EUSA Pharma gives them access to a portfolio of four drugs that treat rare cancers.

Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.

Subtitle FDA approved rituximab in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.

The companies will focus on the rapid development of polymerase chain reaction assays for emerging pathogens and potential health threats, including biological threats.

Fujifilm’s center adds local support in Suzhou, China for cell culture media optimization.

This collaboration aims to better understand Alzheimer’s and Parkinson’s disease and increase drug discovery and development success rates.

Moderna’s agreement with the UK government includes 29 million COVID-19 vaccine doses for delivery in 2022 and 31 million doses for delivery in 2023.

High price tags threaten to block patient access to potentially life-saving cures and treatments.

The new General Chapter <1469> “Nitrosamines Impurities” by USP became official on Dec. 2, 2021, in the United States Pharmacopeia—National Formulary.

EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.

Lean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.

Chinook Therapeutics has formed a 50/50 joint venture with investors to develop kidney disease therapies in China.

Sartorius is investing €100 million (US$113 million) between 2021 and 2025 to expand capacities for production, innovation, and storage at its French facilities in Aubagne, Cergy, and Lourdes.

Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.