A Primer On The Importance Of Ancillary Materials In The Manufacture Of Biologicals

By Rob Wright, Chief Editor, Life Science Leader magazine

The U.S. Pharmacopeia, USP, will be holding its "Science & Standards Symposium on Biologics and Biotechnology, October 3 – 6 in Seattle, WA. Bill Tente, VP of manufacturing and regulatory affairs for Humacyte, is serving as the session chair for Ancillary Material Standards. This session will discuss the value of standards for ancillary materials and the quality impact of ancillary and process materials in the biologics manufacturing process. I had the opportunity to ask Tente, a 30-year veteran of the biotech industry, a few questions to gain a better understanding of some of the issues which surround the manufacture of biologics.

Life Science Leader (LSL): What are ancillary materials and why are they important in the manufacture of biologicals?

Bill Tente of Humacyte: Ancillary materials are components used in the manufacture of biologicals. They frequently impart some important biological function in the synthesis of the biological; for instance, to induce the production of a cytokine from a cultured cell. Since they are not present in the final dosage form, they are not excipients.

LSL: What are some of the main facets of qualifying ancillary materials?

Tente: Assurance of quality is critical with ancillary materials because they have a direct influence on the safety and potency of biological products. In addition, many ancillary materials are biological in nature and are subject to variability. Understanding the extent of variation and the tolerance the manufacturing process has for this level of variation in the ancillary material is important.

LSL: Are innovators required to do the same level of qualification that a large bio-manufacturing company undertakes?

Tente: In practicality, innovators must rank order the level of qualification for each ancillary material used in the manufacturing process in order to move forward with pre-clinical and clinical studies. Innovators should start with developing good characterization assays for a biological product in order to determine the impact of lot-to-lot variation of an ancillary material. Then the robustness of manufacturing can be ascertained. Having assays that assess biological function of the final product facilitates this activity.

LSL: What role is USP playing in this field?

Tente: USP has published informational chapter <1043>. It addresses best practices for qualifying ancillary materials. In addition, there will be a full session devoted to ancillary materials at the upcoming USP Scientific Meeting in Seattle in October.

LSL: As the VP of manufacturing and regulatory affairs, what are your primary resources for staying up to date in your field?

Tente: In addition to staying abreast of the current literature, I am fortunate to have a great informal network that is wonderful for sharing the latest information. Being a USP volunteer is also a big help for staying current.

LSL: Given your responsibility for FDA submissions, what advice would you give to others on getting a successful outcome from a submission?

Tente: Understand your manufacturing process, pick the best vendors for ancillary materials, develop characterization tests that assess biological function of the product and solicit help from those experienced with the development of biological products.

I hope this has provided you with some insight into ancillary materials and the possible benefit of attending this conference. If you plan to go, be sure to seek out Life Science Leader magazine contributing editor, Wayne Koberstein. If you would like to get something scheduled with him in advance, drop him an email via LinkedIn or directly at wkoberstein@comcast.net.