Contract Manufacturing, Drug Substance, API

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.

A new report gives an overview of the work of the International API Inspection Program.

On Tuesday, April 24, 2018, Evan Boswell, senior principal scientist at Pfizer CentreOne Contract Manufacturing, Pfizer CentreOne will give a presentation on scaling up the manufacturing process of active pharmaceutical ingredients at CPhI North America in Philadelphia, PA.

The active pharmaceutical ingredient and excipient provider has expanded its parenteral ingredient manufacturing capacity and lab services.

A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.

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

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

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

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

Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.

The API manufacturer has announced that it has completed the expansion of large-scale manufacturing capabilities at its Charles City, Iowa site.

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

CordenPharma will integrate the Hospira Boulder API manufacturing facility into the CordenPharma Colorado network for highly potent and oncology APIs.

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

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.

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

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.

A $5.5 billion acquisition brings Capsugel’s oral dosage delivery capabilities to Lonza’s portfolio.

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

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

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

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.