Pharmaceutical Technology-08-01-2019

CMOs and CDMOs expanded their services and facilities in the summer of 2019.

Industry experts discuss the role of gene-editing techniques in regenerative medicine and cell-line development.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

Pharmaceutical Technology spoke with Anil Kane, executive director, global science and technology, pharmaceutical development services, at Thermo Fisher Scientific about the industry’s need for more capacity in the manufacture of highly potent APIs.

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

Key considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.

Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.

Tools help lab scientists capture and use more data and work to ensure data integrity.

Bio/pharmaceutical companies are adopting artificial intelligence for discovery, development, risk assessment, safety monitoring, and manufacturing.

Performing a compliance gap assessment and focusing on six key factors in your facility’s process definition and controls can help your facility pass its next FDA inspection with flying colors.

Click the title above to open the Pharmaceutical Technology Outsourcing Resources 2019 in an interactive PDF format.