Development

Articles

Cambrex’s expanded quality control laboratory supports generic API development.

QC Lab Extends Capabilities at Cambrex’s Milan Facility

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Select Suppliers with Demonstrated Expertise to Avoid Sourcing “Bad” APIs

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Locking Fraudulent Materials Out of the Supply Chain

Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.

FDA Approves New Treatment for Depression

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

SK Biopharmaceuticals, Arvelle Partner on Anti-Epileptic Drug for Europe

Kieran O’Connor is Analytical Science and Technology senior chemist at SK biotek, Ireland, kieran.oconnor@sk.com. (formerly Bristol Myers Squibb)

John Wasylyk is senior principal scientist at Bristol-Myers Squibb, USA; john.wasylyk@bms.com

Bob Wethman is senior research scientist II at Bristol-Myers Squibb, USA

Ming Huang is senior research investigator I at Bristol-Myers Squibb, USA

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing. 

Spectroscopy Facilitates Lean Analysis

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

Almac Group Implements Continuous Flow Expertise at Global HQ

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018. 

API Synthesis and Manufacturing, Small Molecule