News

Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis’ gene-therapy manufacturing capacity.

The partnership will enable the Applied Process Company (APC) and the National Institute for Bioprocessing Research & Training (NIBRT) to provide increased access to R&D and analytical services.

ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.

XenTech and the Gustave Roussy Cancer Center have signed a strategic collaboration agreement aimed at the development of a collection of tumor explant models from patients with acquired resistance to targeted therapies.

NJII and Pall collaborate to address biomanufacturing technology and workforce development challenges.

The GE Healthcare and Rockwell Automation collaboration will help meet the needs of the biopharma 4.0 era.

The company has launched a comprehensive portfolio of custom cell biology solutions and a new cell-line engineering technology.

The collaboration will apply artificial intelligence and machine learning to the development of drugs for treating a range of cancers.

MilliporeSigma added a new cloud-based, remote lab water service and monitoring capability to its Milli-Q CLX 7000 clinical water purification system.

Worth up to $605 million, the collaboration will focus on studying a preclinical novel target that could lead to potential new treatments for autoimmune diseases.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

Distek, a provider of laboratory testing instruments, added a dual impeller single-use bioreactor (SUB) system to its BIOne portfolio.

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.

A continuous peptide manufacturing process invented by Swedish Biomimetics 3000 Ltd is a platform technology also applicable to other solid-phase chemical processes, such as chromatography.

Waters debuted a range of new TA Instruments innovations and the BioAccord System at Pittcon 2019 in Philadelphia, PA, on March 17–21, 2019.

Katalyst D2D from ACD/Labs enables the design, planning, execution, and analysis of high throughput (HT) experiments. The web-based application was introduced at Pittcon 2019 in Philadelphia, PA.

The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.

A $1.7-billion acquisition CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.

PDC*line Pharma has entered into a licensing agreement with LG Chem to develop a lung cancer vaccine in Asia.

Cell Mogrify (Mogrify), has been granted funding by the UK’s innovation agency, Innovate UK, to accelerate regenerative cell therapies.

Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.

The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.

Bruker highlighted new analytical systems for several industry applications, including pharma, materials science, and clinical/preclinical research.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

Alcami Biologics formed to meet market demands for biological drug development services.

The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.

A $100-million investment will expand a range of the CDMO’s service capabilities and offerings.