Outsourcing

As the field of bioanalytical testing evolves, it is important for drug developers to stay at the forefront of the advancements to ensure they remain competitive.

Christian Cobaugh, CEO and founder of Vernal Biosciences, considers the outsourcing landscape for mRNA production.

Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceutical products.

The addition of BIOVECTRA’s biologics capabilities to accelerate drug development and manufacturing will allow Agilent to expand its end-to-end offerings for biopharma services.

Pluri’s newly launched CDMO business will manufacture two novel cell therapy product candidates for Kadimastem.

With the acquisition, Olink will join Thermo Fisher’s Life Sciences Solutions business.

This collaboration aims to support and accelerate clinical development of advanced and novel technologies.

The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.

Swiss CDMO CordenPharma and Spain-based Certest will collaborate on the development of ionizable lipids for LNP formulations.

Asking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.

Enzene's new division will provide end-to-end integrated discovery services.

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

This article looks at the relationship between a CDMO quality organization and the client.

The Mirus Bio acquisition will boost Merck KGaA’s viral vector manufacturing services.

The need for preclinical testing expertise is growing as molecular complexity increases.

The rising demand for biologics and technological innovations are driving blow-fill-seal capacity, harnessing manufacturing efficiency, and benefitting patients.

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

Key areas to invest include manufacturing process improvements, quality management, and AI.

Contract manufacturer SK pharmteco will manufacture as well as conduct testing and release of Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy for bladder cancer.

As the industry adjusts to new regulations, including Annex 1, bio/pharma manufacturers must rethink facility designs to remain in compliance.

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.

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.

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

There are considerations companies may want to consider before seeking out a service provider.

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

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.

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

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

The company is investing more than $2 million in its analytical testing services and adding suppository manufacturing capabilities.

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.