Pharmaceutical Technology-08-01-2016

CMOs that offer an innovative service-oriented model will dominate the industry.

Stability testing programs should provide drug owners the information needed to establish the proper handling, shipping, and shelf-life recommendations for drug products.

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \

Quality, innovation, and new approval pathways open drug development options for the Chinese market, including injectable contract manufacturing.

Bio/pharmaceutical contract service provides continue to invest in development, facility upgrades, technological advancement, and mergers and acquisitions.

New approaches add flexibility and reduce risk for contract development and manufacturing organizations (CDMOs) and their clients.

While isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.

Planning ahead is key to enabling a continuous and secure supply chain that adapts to changes in market demand.

Now past the “wait-and-see” standoff, most pharmaceutical companies and their contract partners are considering long-term requirements, including distributors’ needs.

The author reviews some of the key considerations when selecting a vendor and crucial parameters that must be defined in the tech-transfer process to ensure the greatest chance of success.

Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home. Compliance consultant John Avellanet shares best practices and ways to minimize costs.