Contract Manufacturing, Biopharmaceutical Production

WuXi Biologics is expanding its manufacturing capacity for drug substance and drug product at its sites in Leverkusen and Wuppertal, Germany.

uBriGene Biosciences will acquire Mustang Bio’s Worcester, Mass., CGT manufacturing facility in a deal worth up to $11 million, expanding its operations into the US market.

Synthego has opened its new GMP-compliant RNA manufacturing facility in Redwood City, Calif., for CRISPR-enabled genomics therapeutics.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

The BalanCD CHO media portfolio is designed to ensure maximized growth, viability, and productivity of CHO cell lines.

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

The trends shaping the growth of the biologics outsourcing industry demand attention.

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

Growth in outsourcing has been the result of COVID-19 projects taking precedence, which has pushed some contract manufacturing to second-tier CDMOs.

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

Lonza and Israel Biotech Fund form a two-year agreement to support accelerated development and manufacture of biologics and small molecules.

Pharmaceutical Technology 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.

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

Optimizing the use of partners for clinical trials depends on selecting the right contractor.

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.

CDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.

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.