Contract Manufacturing, General

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

The complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication.

Emerging therapies, patient-centric medicines, and the ever-changing world of bio/pharmaceuticals complicate technology transfer.

According to the survey results, 49% of industry respondents are “highly positive” on the contract services sector seeing growth over the next 18 months.

Qualifying material suppliers is a crucial step in ensuring safe and effective drug 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.

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.