Contract Manufacturing, General

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.

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

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

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

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

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

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 company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

The expansion will boost solid-phase peptide synthesis total reactor volume to 32,000 L.

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

Consistent growth in outsourced biomanufacturing points to an evolving industry increasingly reliant on external capacity and expertise.

WuXi XDC will provide end-to-end services to support Boostimmune’s discovery of novel bioconjugates.

More than a third of CMOs are struggling to keep skilled technical and production staff.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

WuXi STA’s new high-potency injectable line has an annual capacity of 12 million units.

What factors do CDMOs consider vital to their success?

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

As new manufacturing processes and technologies are introduced to meet demand and overcome challenges, understanding also needs to improve to ensure the right balance is achieved.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.

The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

Sponsors should explore key considerations ahead of choosing a new outsourcing partner.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.

The latest CPHI report has been published, predicting that a significant shift in outsourcing strategies is being experienced globally.