Biologics APIs

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

Process analytical technology paved the way for continuous manufacturing.

As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.

W.R. Grace & Co. will sell its chromatography product lines, which includes chromatography instruments, columns, and other related products.

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

Analytical laboratory equipment adapts for new realities of downsizing, outsourcing, and speed demands.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

Mass Spec Lab, a privately owned analytical company, announced its official launch on Dec. 28, 2015 in Southern California.

Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.

AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.

A strong API market is expected in 2016 despite fewer new drug approvals.

A study backed by the Centre of Regenerative Medicine found that laminins are crucial cell components that could help aid the commercial production of stem cell therapies.

The new sugars are touted to increase the efficacy of active pharmaceutical ingredients and improve cell culture yield.

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.