|Articles|June 19, 2023

Straight From the Source: Streamlining Scale-up With Quality Raw Materials

As processes increase in scale, the greater raw material volumes and stricter quality requirements can make it challenging to deliver an effective and economically feasible product. In this how-to guide, we discuss the common challenges that developers face when moving through process development and outline the essential steps for streamlining scale-up through effective raw material sourcing.


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.