Contract Manufacturing, Biopharmaceutical Production

Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource.

Outsourcing partners are ready to fill the market need for greater cell therapies capacities.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

BioPharm International spoke with Colleen Floreck, vice president, Global Marketing and Strategy, Catalent Cell and Gene Therapy about the specific requirements and challenges for expanding production of viral vectors.

Capacity concerns and regulatory compliance considerations will drive the decision about outsourcing the manufacture of clinical trial materials.

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

Recipharm has strengthened its biologics manufacturing capabilities with the acquisition of both Vibalogics and Arranta Bio.

Thermo Fisher Scientific is expanding its Millersburg, Penn., site with a $40 million investment to support increased production of single-use technology for critical vaccines and biologics.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Arranta Bio will use Cytiva’s FlexFactory single-use manufacturing platform to produce mRNA vaccines.

Recipharm will build up its biologics service offering with the acquisition of GenIbet.

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.

The agreeement will add to Merck KGaA’s LNP and mRNA capabilities.

With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.

FUJIFILM Irvine Scientific’s new manufacturing facility in Tilburg, the Netherlands, is now fully operational.

FUJIFILM Diosynth Biotechnologies plans to invest £400 million (US$528 million) to expand its Billingham, Teeside facility in the United Kingdom.

Lonza has signed a five-year services agreement to provide for the development and manufacturing of biologics and small molecules for portfolio companies owned by Bioqube Ventures.

Leucid Bio will collaborate with Lonza to use Lonza’s Cocoon Platform for clinical and commercial manufacturing of CAR T cells for Leucid’s lead candidate.

Sartorius is investing €100 million (US$113 million) between 2021 and 2025 to expand capacities for production, innovation, and storage at its French facilities in Aubagne, Cergy, and Lourdes.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

Avid Bioservices is building a viral vector development and manufacturing facility near its existing biologics manufacturing facility in California.

AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.

AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.