At RSSL, we combine deep scientific expertise with advanced laboratory capabilities to deliver comprehensive biosafety testing and analytical solutions that safeguard your products, protect your reputation and support global regulatory compliance. From routine microbial testing to complex investigational analysis, our biosafety services are designed to keep your pharmaceutical, biotech and specialty pharma products on track.
Our state of the art biosafety laboratories feature segregated bioassay suites and one-directional PCR suites, purpose designed to eliminate cross-contamination risk and deliver world-leading biosafety analytical services. From microbial testing to contamination investigation and impurity analysis, RSSL provides fast, reliable biosafety results tailored to your project timeline.
We go beyond routine biosafety testing offering client specific method development and validation in accordance with ICH Q2(R2) standards and global GMP biosafety standards, ensuring both compliance and analytical accuracy at every stage.
RSSL is a trusted biosafety testing partner for global pharmaceutical, biotech and specialty pharma organisations. Whether you require routine biosafety testing, bespoke method development or advanced investigational analysis, our industry leading expertise helps you meet critical milestones without delays keeping your products on track for success.
Ready to discuss your biosafety testing requirements? Contact our team to find our biosafety solutions can support you.
Biosafety testing is a series of analytical tests that confirm pharmaceutical and biopharmaceutical products are free from harmful biological contaminants including bacteria, mycoplasma, viruses and endotoxins. These tests are essential to protecting patient safety and ensuring product quality throughout development and manufacturing.
Most biologics require sterility testing, mycoplasma testing, adventitious virus testing, endotoxin testing and bioburden testing prior to release. The specific requirements will depend on your product type, route of administration and the expectations of your target regulatory authority — whether that's the MHRA, EMA, FDA or others.
Sterility testing confirms the complete absence of viable microorganisms in a finished product. Bioburden testing quantifies the microbial load present on raw materials or in-process samples.
Mycoplasma are small, slow-growing bacteria that can contaminate cell cultures without any visible signs. Left undetected, mycoplasma contamination can compromise product safety, alter cell behaviour and invalidate entire production batches. Routine mycoplasma testing is a regulatory requirement for all cell-derived biologics and early detection saves time, cost and risk.
Biosafety testing must comply with Good Manufacturing Practice (GMP) requirements, ICH Q2(R2) for analytical method validation and relevant pharmacopoeial standards including Ph. Eur., USP and JP.
Turnaround times vary depending on the test. We work closely with our clients to align testing timelines with project milestones and offer expedited services when you need results fast.
We offer client-specific method development and validation in accordance with ICH Q2(R2) standards. Our multi-disciplinary team will develop a tailored approach that ensures both compliance and analytical accuracy.
