Manufacturing Services

Mergers and acquisitions have changed the shape of the contract services market as big players seek to build full-service capabilities.

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.

GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.

Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.

Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.

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

Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.

Xcelodose provides automated processing of API directly into capsules at low doses. The expansion of Xcelodose reinforces Juniper’s early stage capsule filling capability.CDMO Juniper Pharma Services, a subsidiary of Juniper Pharmaceuticals, announced that it has expanded its Xcelodose powder micro-dosing system. This move reinforces the company’s early stage capsule filling capability.

Ash Stevens has received FDA’s approval to manufacture Takeda’s multiple myeloma drug, ixazomib, at its facility in Riverview, Michigan.

The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.

Expansions at Catalent’s Kansas City, MO, and Madison, WI facilities made in response to industry demand.

Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.

Industry veteran Mark Kontny joins board of directors at Grand River Aseptic Manufacturing.

Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry of the 21st century, according to Christian Treitel from Bosch Packaging Technology.

In the past, contract manufacturing organizations (CMOs) and contract development manufacturing organizations (CDMOs) have been focused most on achieving scale, reaching new clients in new geographic regions, and adding services that were previously unavailable, according to Gil Y. Roth, president of the Pharma and Biopharma Outsourcing Association. In a new report from CPhI, Roth explicates how consolidation has changed how CMOs position their services to clients and how CMOs add value to their businesses.

Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.

Contract manufacturer PiazaBio announces services for Western Pharma companies seeking to enter the China market.

Despite emergence of biologics, small-molecule APIs benefit from industry growth.

Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

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

Kason’s Vibro-Bed fluid-bed agglomerator is equipped with imbalanced-weight gyratory motors and mounted on a spring suspension.

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

Catalent selects advisory board members to complement Redwood Bioscience Scientific Advisory Board.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.