News|Articles|October 17, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

  • PTSM: Pharmaceutical Technology Sourcing and Management-11-02-2016
  • Volume 11
  • Issue 11

CordenPharma Completes API Process Bay

CordenPharma announced the completion of a new highly potent process bay for APIs at the company’s Colorado facility.

On Oct. 17, 2016, CordenPharma announced that the company has completed a recent investment to strengthen development and manufacturing capabilities for API offerings across its highly potent and oncology platform. The new API process bay, now installed in the company’s Colorado facility, is designed to handle a wide range of chemistries and unit operations with flexible and scalable components up to multi-kg batches.

This investment comes after the completion in early 2016 of a new cancer target discover and development (CTD2) facility for the development and manufacture of oral solid-dosage drug product and manufacture of highly potent and oncology compounds in its CordenPharma Plankstadt, Germany facility. The company also expanded capabilities in handling sterile oncology drug products at CordenPharma Latina, Italy.

“With the operational qualification now complete, the first cGMP campaign is scheduled to be completed in early Q4 2016,” Brian McCudden, president and managing director of CordenPharma Colorado, said in a statement. This new addition complements the existing infrastructure at CordenPharma Colorado, which is equipped to handle highly potent compounds up to OEB Level 5 spanning development to commercial-scale.

Source: CordenPharma

 


Related to this article

Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation. | Image Credit: ©HockleyMedia24/peopleimages.com -stock.adobe.com
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Complying with International Pharmacopoeias
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
CPHI Milan 2026: Nitrosamine Risk Mitigation, Part 2
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.