Contract Manufacturing, General

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

Biopharma employees reveal employment objectives, opportunities, and frustrations.

Almac Group will acquire BioClin Laboratories to expand Almac’s analytical service offerings.

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

The Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Technology advances enable contract service providers to keep pace with the demands of existing and emerging biologic-based therapies.

Contract service providers debate the pros and cons of consolidation, accelerated drug approvals, regulatory issues, and the impact of new therapies.

Biopharmaceutical contractors continue to invest in development, facility upgrades, technological advancement, and mergers and acquisitions.

Advances in single-use systems, consumables, and continuous manufacturing show steady progress.

Pfizer announced the launch of Pfizer CentreOne, a CMO formed by the combination of Pfizer CentreSource and Hospira One 2 One.

Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.

Under the terms of the agreement, Xellia will acquire substantial parts of the Ben Venue site, including four sterile injectable manufacturing plants, which are not currently operational.

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

CMC Biologics and River Vision Development announce manufacturing agreement for RV001, a monoclonal antibody to treat Grave’s orbitopathy.

The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.

The new project will increase fill/finish manufacturing capacity for select products on FDA’s Drug Shortage Index.

Jim Miller, President of PharmSource, speaks with BioPharm International.

Jim Miller, President of PharmSource, spoke with BioPharm International about working with CMOs and CDMOs.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.