Outsourcing

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

Key considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.

Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. 

Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.

An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.

CatSci has received two accolades from Welsh organizations, demonstrating its contributions to the Welsh economy in the field of process R&D.

The expansion of Lonza’s Tampa site includes development and manufacturing capabilities for oral solid-dose drugs.

Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

New CDMO facility supports early-stage API manufacturing and scale up.

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

Tergus Pharma announced a partnership with Great Point Partners and construction of a new commercial manufacturing facility in North Carolina.

CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.

With an increased focus on the supply chain security of non-cGMP intermediates, companies need to re-emphasize upstream manufacturing.

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

New offering from Catalent targets integrated development and manufacturing of biologic drugs.