Quotient Sciences Featured in Contract Pharma's feature on HPAPI Outsourcing
Senior Director of Product Development, Robert Cornog, and Senior Director of Integrated Development, Brad Rowe, recently contributed to Contract Pharma's feature on HPAPI outsourcing, "Why HPAPI Outsourcing Is Surging", explaining the evolving demand, regulatory shifts, and analytical challenges shaping the HPAPI contract manufacturing market.
When speaking on regulatory pressures, Robert Cornog states, "Recent regulatory focus on workers' safety and risk-based applications to cross-contamination has been driving the increasing need for isolation controls and validated operations, particularly for multi-product facilities. These considerations are being pushed earlier and earlier into the conceptual and design phases for equipment and facilities."
When addressing analytical challenges, Brad Rowe explains, "The manufacturing of HPAPI drug products requires the demonstration of very low acceptable levels of residual compound on the manufacturing equipment, which can pose challenges in cleaning verification analysis and their quantification limits. Likewise, HPAPI drug products tend to be on the very low end of product strengths, again making assay, and in particular related substances analysis, challenging to achieve the appropriate levels of quantitation limits."
When asked how CDMOs are addressing these challenges, Rowe says, "Methodology that targets the analysis of specific compounds, such as HPLC-Mass Spectrometry, can help overcome these challenges with improved quantitative abilities."
To continue reading the full article, visit Contract Pharma's site here.