Outsourcing

PluriCDMO, Pluri's newly launched CDMO division, has been selected by Kadimastem to manufacture two novel cell therapy product candidates.

Thermo Fisher will add Olink to its Life Sciences Solutions business.

HCPs are major process-related impurities that must be monitored throughout biologics production for clearance.

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

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

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

CordenPharma has partnered with Spain-based Certest to develop ionizable lipids for LNP formulations.

The PharmTech Group spoke with BIOVECTRA's director of Business Development, Nucleic Acid Modalities, Jessica Madigan, about the concept of flexibility in outsourcing and the 2024 BIO Convention.

In this episode of Drug Digest, industry experts discuss the current outsourcing landscape in the post-COVID world and the changes the pandemic has enforced in the demand for outsourced bioprocessing services.

Sterling is strengthening its development and manufacturing services for ADCs with a dedicated GMP suite at its Wisconsin facility.

The company’s new division will provide end-to-end integrated discovery services.

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product.

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.