Manufacturing, Biologics

CBER maps modernization plan to handle surge in research and applications.

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.

MilliporeSigma and Lotte Group will collaborate on facility design and workforce training for a new biologics business unit in the US.

Astellas Pharma has opened its new gene therapy manufacturing facility in Sanford, NC, which will support clinical- and commercial-scale manufacturing of AAV vectors for gene therapies.

The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.

Advances in genomics tools can lead to quicker biotherapeutic development.

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

AGC Biologics is investing in viral vector suspension technology at its new Longmont, Colo., facility.

Further development of nucleic acid-based therapeutics has been accelerated by the recent success of mRNA vaccines.

Complex hurdles complicate the development of emerging therapies.

Plant-based manufacturing technology gains mainstream edge in biopharmaceutical production.

Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.

The recent success of mRNA vaccines has opened the door for further and future development of nucleic acid-based therapies.

Spectrum Chemical has further expanded its bioCERTIFIED product portfolio to support the growing global demand for new vaccines and therapeutics.

The use of bioengineering offers practical tools for the evolution of host cells.

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.

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

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.

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.

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.

Modeling techniques can improve process control and monitoring in biopharmaceutical production.

Upstream processing is better optimized with the help of automated workflows.