Manufacturing, Biologic Drugs

Flexible and efficient methods are needed for biopharmaceutical manufacturing.

The struggle to implement continuous biomanufacturing at GMP level is slowly advancing.

Resolving operational bottlenecks makes mAb manufacturing more efficient.

Standardization is needed in CAR-T cell therapy development due to its inherent complexity.

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

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.

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.

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.

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

Workforce training is crucial for biopharmaceutical manufacturing.

Sanofi’s acquisition of Amunix will grant access to their promising immuno-oncology pipeline.

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

Simple, inexpensive real-time analytics are urgently needed for high value products.

Novozymes and Novo Nordisk Pharmatech are teaming up to develop best-in-class technical enzymes to support biopharmaceutical production processes.

BeiGene has acquired property in Hopewell, NJ to build a new manufacturing site and clinical R&D center for advanced new medicines.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

Thermo Fisher’s new Swiss facility will initially produce CSL Limited’s recombinant factor IX product Idelvion.

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.

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.