Manufacturing, Biologics

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.

Following the divestiture of its Elusys subsidiary and other non-core assets, NightHawk Biosciences will transform into a pure-play large-molecule CDMO.

MilliporeSigma’s new platform combines generative AI, machine learning, and computer-aided drug-design aimed at increasing the success rate of new drugs and therapies.

Digital transformation allows for smarter and connected biomanufacturing operations.

Novo Nordisk will invest more than DKK 16 billion (US$2.3 billion) to expand its production facilities in Chartres, France.

Demand for efficient tech transfer, as well as compliant on-time delivery, is rising.

Taking a brief status check on the biologics supply chain and any impact on scale up operations.

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation discusses the analytical and downstream purification challenges of oligonucleotides.

As part of a $30 million investment, Aragen is setting up a new biologics manufacturing facility in Bangalore, India.

Re-evaluating the basics of mAb production may be beneficial for the biopharma industry as a whole.

SCHOTT now offers ViewCell, a new component meant to add flexibility to biopharmaceutical process control.

These results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.

Drug efficacy, reputation, and financial return are all on the line when it comes to fill/finish.

FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

Plasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Image analysis algorithms coupled with microscopy techniques can be used to characterize aggregates of therapeutic proteins.

The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance.

In this episode of Drug Digest, editors discuss what happens in the manufacturing space from a CDMO and a cell/gene therapy perspective.