Outsourcing

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.

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

Cormica’s first US Acquisition is intended to support to organic growth of TPM laboratories.

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

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.

At INTERPHEX 2024, Pharmaceutical Technology sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies to discuss implementation of Annex 1.

Under a collaboration agreement, Lonza will manufacture sabirnetug, Acumen Pharmaceuticals' mAb in clinical development for treating Alzheimer’s disease.

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

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.

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

Noramco Group will be an integrated North American-based API and supply chain services provider.

In a new manufacturing pact, Chime Biologics will produce DT-7012, Domain Therapeutics' antibody candidate for treating cancer that will soon be entering Phase I studies.

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

The Cell Shuttle platform will manufacture cell therapies for its first clinical trials by the end of the year.

The facility producer’s new innovation hub will offer manufacturing, life sciences, and infrastructure services.

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

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

The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.

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

Contract service providers must step up their game to stay competitive in increasingly complex bio/pharma market.

Managing the intricacies of sterile product development is imperative for successful and compliant outcomes.

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

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

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

What do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?

The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.

Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.

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

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.