Outsourcing

Development and adoption of new technologies create challenges that may take years to resolve.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

The company aims to add the additional analytical services in the European Union throughout 2018.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

Biopharm industry veteran Ralf Otto named to lead development and manufacturing at Rentschler Biopharma.

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.

Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.

Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.

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.

The company relocated its headquarters to Riverview, Florida.

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.

Recent investments show expansion activity in cell culture facilities.

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

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 European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

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

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.

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

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

Biopharma employees reveal employment objectives, opportunities, and frustrations.

Developing and retaining qualified employees will test biopharma companies and CMOs alike.