BioSafety

RMC has the experts you need in the field of biosafety testing – to provide you exactly that piece of expertise you are currently missing.

We can help in a number of ways, helping you author documents, perform biosafety technical evaluation, perform risk mitigation and assessments, or simply being your expert advocate when you are working with a contract biosafety testing lab.

Viral and Phage Safety

Viral and Phage risk mitigation

 

Development and implementation of viral testing protocols

 

Development and implementation of viral clearance strategies, including strategies for virus removal and/or inactivation

Mycoplasma Safety

Mycoplasma are infectious agents that may go undetected, are difficult to filter, and do not require a specific host for propagation. Testing protocols from the EMEA and FDA are “lengthy and convoluted”. If you have concerns about mycoplasma detection technologies, protocols, or risk mitigation, we can help:

Cell Line Characterization

For a variety of very good reasons, not the least being regulatory, you should have good characterization of your cell line. Creating a production cell line for your product has been described as “the first commercial GMP task that you undertake, and you do it prior to Phase 1 testing!” Wait, it gets worse, it’s usually done by the R&D group! We can help anticipate problems that you might have with your cell line, and design a program to provide phase appropriate testing and characterization so you have the data when you need it, and you’re not at risk of a bad surprise late in your development program:

Animal Derived Materials

Have you heard? The US and Europe are concerned with anything that has come from an animal, for fear of spreading prion diseases and viruses. Do you have any idea how many things we use that either come from animals or are exposed to animal derived materials during manufacture?

  • We can help you to implement an animal derived materials program for evaluating and minimizing risk associated with these materials
  • We can help to identify alternatives to animal derived materials
  • We can help design and interpret release testing to mitigate risk associated with animal derived materials

Microbial Safety

With all the new biological threats to your processes and products, it’s comforting to know that the tried and true pathogenic bacterial threats still remain and are as vigorous as ever. If you’re seeing these, maybe we can help: