Manufacturing

AstraZeneca’s acquisition of Amolyt Pharma includes eneboparatide, a Phase III therapeutic peptide for the treatment of hypoparathyroidism.

Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) marks the first gene therapy approved in the US for treating children with metachromatic leukodystrophy.

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.

The Italian company’s North American business has seen an increase of 47%.

The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.

Despite a growing number of biosimilar approvals, market uptake remains a challenge.

The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.

Proprietary cell lines offer opportunities for achieving high AAV titers.

A tidal wave of questions floats the need for more upstream automation.

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

The partnership will allow for both companies to provide end-to-end biopharmaceutical manufacturing solutions.

CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.

Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.

AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.

Webinar Date/Time: Wed, Mar 20, 2024 11:00 AM EDT

Challenges in fermentation can be addressed through equipment changes, facility design, and process development.

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

Webinar Date/Time: Tue, Feb 13, 2024 11:00 AM EST

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

Webinar Date/Time: Tue, Mar 5, 2024 2:00 PM EST

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.

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

Despite slow growth over recent years, the CAR-T cell therapy space is expected to see considerable advancements in the near future.

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

SUS aids biopharma manufacturers to overcome the rigidity of more traditional stainless-steel technologies.

Developing freeze-drying processes requires patience and deep product and process understanding.