Manufacturing, Biologics

Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.

Solving the challenge of better-stabilized temperature-sensitive biomolecules hinges on innovative formulation strategies.

The annual survey predicts that four of the five biggest biologics capacity holders in 2028 will comprise CMOs, which will control 45% of all CMO capacity in Asia.

Bringing promising ADC candidates to market faster hinges on the biopharma industry investing in linker design capabilities.

Lilly has increased its manufacturing investment for biologics in Limerick, Ireland, by $1 billion while launching its new $800 million facility in Kinsale.

Scorpius Holdings expects to launch its first CGMP campaign for mammalian-based biomanufacturing in the 2024 third quarter.

BeiGene has invested $800 million into a new biologics manufacturing facility in Hopewell, NJ, which also houses its clinical R&D capabilities.

Ecolab Life Sciences and Repligen introduce DurA Cycle, a new affinity resin for large-scale biologics manufacturing.

Syngene has launched a new protein production platform that offers faster production with lower risk.

AGC Biologics has completed an expansion at its Copenhagen, Denmark, site, which doubles its bioreactor capacity for mammalian-based cell culture.

Packaging and packaging line innovations are addressing the industry’s growing use of biologics.

FUJIFILM Diosynth Biotechnologies CEO Lars Petersen highlights the company’s strategic goals and meeting market demand for mammalian cell culture capacity.

Under this partnership, AGC Biologics and BioConnection will provide development and manufacturing capabilities for biopharmaceutical drug substance and drug product.

This new facility will allow AstraZeneca to offer full manufacturing processing for antibody drug conjugates.

Progression in biopharmaceutical drug development and manufacturing is being boosted by technological advances.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

ADC manufacturing facilities are requiring more stringent containment requirements as well as advanced analytical detection.

The Xcellerex magnetic mixer, single-use mixing system was designed to address challenges in large-scale mAb, vaccine, and genomic medicine manufacturing processes.

WMFTS’ new WMArchitect single-use solutions offers standard ready-to-use single-use assemblies as well as customized designs for biopharma fluid management.

Despite a growing trend toward single-use bioreactors, stainless-steel retains its relevance for certain products.

With the Vacaville, Calif., site acquisition, Lonza gains one of the largest biologics manufacturing sites for mammalian cell-based therapeutics.

The evolution of therapeutic modalities drives the adoption of single-use technologies.

ProBioGen and Mapp Biopharmaceutical will use the former’s GlymaxX technology to develop a cell line for an afucosylated antibody that targets Marburg virus infection

Under a new agreement, Chime Biologics will manufacture Domain Therapeutics’ antibody cancer immunotherapy candidate, DT-7012.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.

Novo Holdings has entered into a merger agreement with Catalent and will acquire Catalent in a deal valued at $16.5 billion.

The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.

Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.

Abzena has launched its AbZelect platforms, designed for improving cell line development.