Manufacturing

The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

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

Reducing US dependency on overseas pharma manufacturing may prove critical in navigating supply chain disruptions.

Eli Lilly and Company are investing $700 million into a Boston-based facility for the newly announced Institute for Genetic Medicine.

Scottish Enterprise has awarded £20 million (US$27 million) to Valneva Scotland to advance vaccine development.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

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.

Hoffman Neopac has signed a partnership with Saperatec to begin recycling aluminum laminate composites upon its opening in mid-2023.

Quotient Sciences announces that it has integrated drug substance into its flagship Translational Pharmaceutics platform.

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

The commercialization and licensing deal will see Biogen commercialize Xbrane’s Xcimzane, a proposed biosimilar for CIMZIA (certolizumab pegol).

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.

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution

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.

In an agreement with MaaT Pharma, Skyepharma will build MaaT a dedicated 1500-m² microbiome ecosystem therapies manufacturing site.

The need for specialized skills in biopharmaceutical manufacturing requires workforce training.

Eli Lilly and Company is investing $1 billion to establish a new manufacturing stie in Concord, N.C., to manufacture parenteral products and devices.

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.

A rich clinical pipeline of regenerative medicine product candidates bodes well for a robust future.

The growing use of automation and digitalization technologies push cell culture bioprocessing forward.

The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.

Lighthouse manufacturing techniques utilize technology and automation to streamline production.

Build into the chemistry, manufacturing, and control strategy the ability to pivot and be flexible should the course change.

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.

Innovations aid efficient processing.

Texcell North America’s new lab facility in Frederick, Md., will expand the CRO’s capabilities in R&D cell culture, viral clearance studies, and viral safety testing.

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.

PhoreMost has entered into separate collaboration agreements with Polaris Quantum Biotech and NeoCura Bio-Medical Technology to discover and develop novel cancer therapeutics.