Active Pharmaceutical Ingredient Production
FROM THE EDITOR
-
![GettyImages-1173740593]( "Halozyme's Outsourcing Tip: The External Manufacturing Site Lead")
Halozyme's Outsourcing Tip: The External Manufacturing Site LeadHalozyme's API production has occurred at two U.S.-based CDMOs since its first commercial approval in 2013. The biotech works closely with both on new API generations and biologic processes, leading to additional regulatory filings. Here's a key ingredient to that success.
William King was a career J&J executive who decided he had to leave the company. Ironically, it was so he could devote himself to solving a growing challenge there. “We had these important ‘lifecycle insights’ that we couldn’t take action on, despite having all these data points coming in,” says the CEO of Zephyr Healthcare.
Here’s your news bulletin: Another experienced source goes on record sharing three basics to selecting the best CMO: credibility, work ethic, and relationships. “I gained experience and understanding of outsourcing from running our own CRO,” says Chris K. Achar, CEO of Genzum Life Sciences.
Fear is discernable in the voices of executives at BioPharma companies when considering a capacity crunch at CMOs. There’s also a rising resignation. Getting on CMO production schedules and securing commitments is a here-and-now challenge.
ARTICLES
-
![Complex Molecule]( "Flow Chemistry: Scale-Up Solution For Modern API Manufacturing")
Flow Chemistry: Scale-Up Solution For Modern API ManufacturingOnce deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.
-
A High Volume Process For Highly Potent (HP) Active Pharmaceutical Ingredients (APIs)
This case study demonstrates how a commercial manufacturing partnership between Alkermes Contract Pharma Services (Alkermes) and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent (HP) Active Pharmaceutical Ingredients (APIs).
SUPPLIER PROFILES
-
Kemwell Biopharma
With manufacturing locations in Bangalore India, and Uppsala Sweden, Kemwell offers the entire value chain from early & late stage drug development services, clinical trial supply support, to commercial contract drug manufacturing.
-
Novasep
Novasep brings innovative solutions to complex challenges within the life science industries for the production of synthetic molecules and biomolecules.
-
Pharmatek Laboratories, Inc.
Pharmatek Laboratories, Inc. is a premier pharmaceutical chemistry development organization supporting the pharmaceutical and biotechnology industries.
-
PYRAMID Laboratories, Inc.
PYRAMID Laboratories, Inc. (PYRAMID), established in 1988, is located in Southern California, USA. Our facilities are housed in three (3) buildings covering approximately 70,000 sq. ft.
-
Recipharm AB
Recipharm is one of Europe’s leading pharmaceutical Contract Development and Manufacturing Organisations (CDMO).
NEWS
-
Aesica Wins European Outsourcing Award For UCB Acquisition Strategy And Implementation10/29/2012
Aesica, the global contract manufacturing organisation (CMO), announces that it has won the European Outsourcing award for ‘best acquisition’ following the successful acquisition and integration of three different UCB sites – at Monheim and Zwickau in Germany, and Pianezza in Italy in 2011.