Outsourcing

CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.

This article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products.

Research suggests that working with a single contract partner can reduce development time and improve economics.

Joe DiMasi, director of economic analysis and research associate professor, Tufts Center for the Study of Drug Development (CSDD), discussed research into the impacts of working with single source contractors with Pharmaceutical Technology.

The companies will be integrated to form the newly-branded AGC Biologics, which will specialize in customized contract development and manufacturing organization services for the scale-up and cGMP manufacture of protein-based therapeutics.

The contract development and manufacturing organization has invested £30-million (US$42 million) at its Dundalk, Ireland site to offer expanded clinical trial services.

Hovione has installed a new MG2 Tekna Precision Capsule filler at its Portugal site.

Flexibility, innovation, and creativity are critical for success in navigating the challenges facing the bio/pharmaceutical industry.

KBI Biopharma's acquisition of Elion Labs expands KBI's biophysical and analytical characterization capabilities.

Paragon Bioservices will build a new cGMP facility in Maryland and expand its existing cGMP facility at the University of Maryland's BioPark.

The acquisition strengthens Charles River Laboratories’ capabilities in the oncology and immunology therapeutic areas.

A ceremony was held at Cambrex’s Karlskoga facility to mark the commencement of a long-term manufacturing agreement with AstraZeneca for a key intermediate.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

Bio/pharma professionals manage expectations amid industry uncertainty.

The industry will see an impact from financing, M&As, advanced therapies, generic drugs, and the retail market in 2018.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.