Manufacturing

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.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

Given its positioning at each new year’s commencement, the J.P. Morgan Healthcare conference helps establish the tone with which the pharmaceutical industry is viewed.

Webinar Date/Time: Thu, Feb 22, 2024 11:00 AM EST

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.

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.

Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.

Boehringer Ingelheim is investing €120 million (US$131 million) into its Koropi, Greece site to expand production for new therapeutics.

Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

Cherwell Laboratories’ cleanroom microbiology solutions will join AnalytiChem’s group of seven companies across Europe, North America, and Australia.

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.

Revolutionary therapies restructure pharmaceutical manufacturing.

There are positive indications for future growth.

The authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.

The success of mRNA-based vaccines paves the way for mRNA in oncology and beyond.

Both adherent and suspension cell culture approaches have their pros and cons, which must be considered for process development.

Through Syena, its oncology-focused product company, Replay will develop and manufacture T-cell receptor and natural killer cell therapies with the NIH and Miltenyi Biotec.

Is increasing molecular diversity pushing manufacturing ecosystem consolidation toward turnkey solutions?

Tome Bioscience is facilitating the transition in biology from the editing phase to the cut-and-paste phase.

Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.

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

Bristol Myers Squibb and SystImmune plan to co-develop and co-commercialize lead ADC candidate for cancer treatment in US.

Webinar Date/Time: Thu, Jan 25, 2024 11:00 AM EST

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.