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

We start with a formal risk assessment and/or gap analysis, to help you understand your vulnerabilities to phage and viruses
We will identify and help implement mitigation techniques for viral and phage contamination risks
After we’re gone, you’ll want a lasting viral/phage risk reduction program, which we will create through procedures, training and technology (see also Animal-Derived Materials Program)
If it’s too late, and you’ve had virus or phage infection in your plant, we can help with investigations, including root cause investigation and clean-up plans
- Articles:
  - Cache Valley Virus
  - Adventitious Viral Contamination: Who is at Risk?
- Blog discussions:

Development and implementation of viral testing protocols

Blog discussions:
- Retrovirus safety testing
- Additional testing needed for viral vaccines

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

Article: Gamma irradiation of frozen animal sera
Blog discussions:

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:

We can help with routine lot release testing method review and interpretation
If you’ve had a positive mycoplasma result, we can assist with investigation and remediation
If you’re ready for faster and more specific testing, we have experience with the wide variety of nucleic acid based mycoplasma methods, and we can help you find one for your application, or steer you away from something that looks sexy, but will be difficult to gain regulatory acceptance
Using ICH Q8 tools, we can perform a risk mitigation exercise for mycoplasma
- Articles:
  - Gamma irradiation of frozen animal sera
  - USP <63> Mycoplasma Tests
- Blog discussions:

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:

We can help you identify the right host, and the right expression technology for your product
When you’ve screened for a high expressing clone and created a Research Cell Bank or Master Cell Bank, we can help you design a cell authentication protocol and help you find cost effective contractors to carry out the work
When the work is complete, we can help with the interpretation of the results and assist with testing and investigation of testing failures
- Articles:
- Presentation: Cell Authentication: Think of it as Career Insurance
- Blog discussion: Cell line authentication

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
- Case study: Root cause investigation of a master cell bank test
- Blog discussions:
  - Using Porcine Trypsin?
  - Animal Derived Materials: Part 1, Part 2, Part 3

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:

For development and validation of methods related to endotoxin and microbial contaminants, see our Analytical Services.
There are some rapid methods that are available to speed up the evaluation process for process fluids and process intermediates. We can help with assessment , selection, and implementation of these technologies
Don’t ignore the possibility of biofilm production with Mycobacteria. Yes, this has occurred in the past and your bioburden assay may not detect it. Ask us for help in understanding and mitigating the risk.
- Article: Mycobacterium contamination of a Mammalian cell process
- Blog discussion:
  - Mycobacterium risk
  - Selecting a rapid microbial detection method

BioSafety