Outsourcing

Innovative technologies and services meet needs for existing and emerging biologic-based therapies.

The new facility is solely dedicated to offer extractables and leachables (E&L) testing services to the pharmaceutical and related industries.

The CordenPharma Chenôve, France manufacturing facility completed an FDA Inspection with no 483s reported.

API and drug product manufacturer changes name to align with parent company.

FDA found no observations during recent inspection of Regis Technologies manufacturing site.

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

The agreement comprises technology transfer and commercial manufacturing of Tillotts’ gastroenterology products.

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.

AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

Piramal Enterprises has entered into an agreement to acquire 100% stake in Ash Stevens all by cash for a consideration of $42.95 million plus an earn-out consideration capped at $10 million.

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

Quebec, Canada-based contract development and manufacturing organization has joined the Pharma & Biopharma Outsourcing Association.

The Claristep filtration system from Sartorius improves preparation of samples for analytical testing.

The manufacturing subsidiary of Astellas Pharma in Oklahoma has been transferred to CMO Avara and renamed Avara Pharmaceutical Technologies.

CMOs are working hard to improve performance by investigating new technologies for filtration and purification.

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.

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.