News

BioPharm International sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies at INTERPHEX 2024 to examine the implementation of Annex 1.

At INTERPHEX 2024, a panel of experts gave insight on new regulatory requirements for contamination control and provided advice for how to implement a contamination control strategy in existing facilities.

The outcomes of a workshop organized by WHO and ICMRA regarding COVID-19 vaccine strain updates are presented in a report published by regulators.

At INTERPHEX 2024, Wenyu Zhang, PhD, covered new trends in the aseptic industry and the key factors companies should consider while weighing their options.

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

At INTERPHEX 2024, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, explores the impact of QMS on quality maturity.

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.

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

Bill Whitford, Strategic Solutions leader at Arcadis, reviews the progress made in 3D bioprinting toward commercial biologics production at INTERPHEX 2024.

This investment will bolster the company’s large-scale cell culture CDMO business at its planned Fujifilm Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina.

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

The collaboration aims to reduce manufacturing time and costs, allowing more access to specialized cancer treatments.

In back-to-back deals, Charles River will offer plasmid DNA manufacturing services for a gene therapy under development by Axovia Therapeutics and for a lead candidate being developed by Ship of Theseus.

Memel Biotech aims to offer a range of services from discovery through to formulation for preclinical through to late-stage clinical and commercial production of advanced therapies.

Lonza has made a deal with Acumen Pharmaceuticals to manufacture sabirnetug, a mAb that will soon be entering Phase II development for treating Alzheimer’s disease.

In a $1.8 billion transaction, Genmab will gain three clinical-stage next-generation ADC candidates with its acquisition of ProfoundBio.

Univercells and Altamira Therapeutics are collaborating on nanoparticle-delivered mRNA vaccines, while Andelyn Biosciences and Grace Science are partnering on novel therapies for NGLY1 deficiency.

J&J’s nipocalimab is in development for reducing the risk of FNAIT in alloimmunized pregnant adults, a rare disease that may risk the life of the fetus or newborn.

AstraZeneca notes that Ultomiris is the first and only long-acting C5 complement inhibitor that offers NMOSD patients the potential to live without relapsing.

The new Verafit products from STERIS are designed to help manufacturers conform to regulatory requirements laid out in Annex 1.

AbbVie’s acquisition of Landos includes a lead asset that boosts its portfolio in autoimmune and inflammatory diseases, while the ADC, ELAHERE, gets full FDA approval.

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

CDMO White Raven aims to reduce contamination risk and gain the capability to handle multiple product formats with the installation of Cytiva’s SA25 Aseptic Filling Workcell.

The health data science division of Optima Partners, bioXcelerate, has released a tool aimed at accelerating the drug discovery process.

Cellares CEO Fabian Gerlinghaus explores advancements in counterflow centrifugal elutriation and electroporation, teasing exciting developments in product testing.

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.

In a non-exclusive licensing agreement, Ricoh will have access to ERS Genomics’ CRISPR/Cas9 genome editing technology to create novel disease models.