Got Animal Derived Materials?

By Ray Nims

Most biopharma manufacturing processes utilize a few raw materials (including cell substrates, excipients, materials which come into contact with the product, etc.) derived from animals or which have been in contact with animal-derived materials at some point. As part of a formal animal-derived materials program, the biopharma must assess the viral and TSE risk associated with such materials. Let’s consider the viral risk first. From a viral safety standpoint, it is important for each biopharma to consider such ingredients and to be aware of the inherent risk of transmitting virus into the product via the materials. Why? As Genzyme discovered in the spring of 2009 (http://www.genzyme.com/corp/media/GENZ%20PR-061609.asp), viruses can infect the upstream manufacturing processes with results devastating to both the biopharma and to the patients its products are intended to treat. Viral risk mitigation, and regulatory guidance (e.g., EP Chapter 5.1.7: Viral Safety), require that viral risk assessments be performed for animal-derived materials used to manufacture biologics. In this context, raw materials include also excipients, growth media, column packing resins, and cell substrates.


For each product, manufacturers should list the animal-derived materials utilized, and should perform a viral risk assessment for those materials. This assessment considers the animal species and tissue, the processes used to manufacture the raw material, the quality control testing performed on the raw material, and in some cases, the manufacturing process in which the raw material is to be used at the biopharma. Inspectors from the EMEA will not only expect the risk assessments to have been performed and documented, but will expect that the assessment process be formalized into a business practice or standard operating procedure. The staff performing the assessments should be qualified for this task and the assessment team should include staff knowledgeable in virology, viral inactivation and removal, and the manufacturing and purification processes employed for the specific product at the biopharma.

Viral risk assessments completed for individual raw materials may eventually be rolled up into a viral safety assessment for the product per EP Chapter 5.1.7. This product evaluation will also consider other factors, such as the patient profile and route of administration, the cell substrate, the types and pathogenicities of viral contaminants found in the cell substrate and the manufacturing process, the amount of bulk material required for a human dose, and the viral inactivation and removal capabilities of the manufacturing downstream processes.

RMC Pharma is 5!

RMC Pharmaceutical Solutions celebrated its 5 year anniversary today. We have grown from a couple people looking for their first consulting opportunity each in our spare bedrooms or kitchen tables to an integrated team capable of taking almost any health care product from conception to commercialization. Today, we are 10 regular employees, with 6000 square feet of office and lab space in Longmont, CO. We've helped 40 clients on three continents with projects ranging from producing pre-clinical proof of concept materials to overseeing pre-approval inspections and quality audits from the biggest pharmaceutical companies in the world. Our capabilities have expanded beyond those of a typical consulting group, to include specialized software such as Slimstat, Minitab, Omnisign, SuperPro and DPL decision modeling software, to laboratory capabilities, including zetasizing, HPLC and Akta based process development. Still, our most valuable resource is our people and the relationships that we've built in our five years. The experience has been very rewarding for me personally, and I hope that my partners, associates and clients have benefited from it as I have.