The Quality Challenge of Biological Raw Materials

Many modern and newly developed medicinal products are based on drug substances and raw materials with biological origin. The breeding of the needed microorganisms and cells, their harvest and the recovery of the necessary components and APIs often implicate a higher risk of contamination. Additionally, the complex structure of these components, of raw materials and APIs necessitate the evaluation of suitable methods for bioanalytical characterisation and quantitative specification. 

Due to the gaps in useful regulatory guidance documents for an effective management and control of raw materials used for manufacturing biological medicinal products, several organisations aim at supporting their members with information and guidance. The EBE (European Biopharmaceutical Enterprises), for example, represents the biopharma industry in Europe and is fully dedicated to being the source of expertise on emerging science and biopharma innovation in Europe. The organisation published the draft "Concept Paper: Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products" last November - with the following purpose:

"This paper discusses background information related to RM regulatory requirements and industry challenges, and then highlights key principles to consider in setting up a risk-based RM management approach and control strategy. This paper then provides an example of how to translate those key principles into a detailed RM risk assessment methodology, and how to apply this methodology to specific raw materials."

Another organisation, the Active Pharmaceutical Ingredients Committee (APIC), focuses on the worldwide quality, Good Manufacturing Practice (GMP) and regulatory matters relating to APIs and Intermediates and represents 64 members across Europe. Finally, the ECA Foundation's educational organisation, ECA Academy, picks up emerging GMP challenges and topical subjects to develop and organise education courses, conferences and webinars about GMP and regulatory compliance. The Foundation's Analytical Quality Control Interest Group will present their new "ECA Laboratory Management Guidance on Analytical Procedure Lifecycle Management" in November.  It is consistent with ICH and USP principles and provides detailed assistance in their practical implementation. 

To build a bridge between the different activities and to discuss them with the concerned experts from the pharmaceutical industry, their suppliers and related authorities, EBE, ECA and APIC joined forces to initiate the conference "Raw Materials Used for Biological Medicinal Products", which will take place on 20-21 November, 2018 in Düsseldorf, Germany. Therefore, you may want to join this conference to benefit from several field reports and case studies on analytical and microbiological control strategies of raw materials as well as on the implementation of regulatory requirements. What's more, both the EBE's Concept Paper and the ECA's APLM Guidance will be presented and discussed in detail.

By the way - as a participant, you may also visit the PharmaLab exhibition area with more than 30 exhibitors from the field of analytics, bioanalytics and microbiology.