Maximize patient safety with rigorous biosafety testing
Solvias offers an extensive portfolio of CMC biosafety testing services. As your trusted partner in biosafety, we offer state-of-the-art facilities, a highly skilled team, and rigorous testing protocols to uphold the highest safety standards.
Unique combination of benefits
- QC release testing in a sterile environment to ensure safety and efficacy
- Expert guidance to tackle biosafety-related challenges
- Rapid microbiological methods that fast-track your product development, delivering results in 5 days
- Strict adherence to international standards (GMP, cGMP, GLP, ISO 17025, OHSAS 18001, ISO 9001, ISO 14001 and international pharmacopeia)
Comprehensive service solutions
Our microbiology labs offer a broad range of testing techniques, including compendial and alternative rapid methods. We provide QC release testing in an aseptic environment and method suitability testing, transfer, and validation of client-specific methods.
We conduct sterility tests in a secure isolator system, handling complex products like antibiotics, gels, ointments, ATMPs, and medical devices. Our services include:
- Sterility testing
- Rapid sterility test (RST)
- Bioburden analysis of TAMC, TYMC, and TAnaerobicMC
- Media fill test (MFT)
- D-value determination of biological indicators
- Verification of biological indicators
- Mycoplasma detection by qPCR
- Container closure integrity test (CCIT)
- Minute virus of mice (MVM) and residual DNA detection by qPCR
We ensure cGMP and Pharmacopoeia compliance and have experience with complex products like ointments and mixed antibiotics. Our services include:
- Microbial enumeration test (MET)–analysis of total counts and specific microorganisms
- Identification of microorganisms by DNA sequencing and Maldi-ToF
- Preservative efficacy testing or challenge test
- Microbial assay of antibiotics
- Growth promotion test of growth media
- Water activity determination (Aw)
We provide a unique in vitro Monocyte Activation Test (MAT) to detect all fever-inducing pyrogens. Our services include:
- MAT in vitro pyrogen test
- Cell-line MonoMac 6: robust test system for QC release
- PBMCs
- Whole blood assay
- Bacterial Endotoxin Test (BET) or LAL Test– Kinetic turbidimetric assay (KTA)
- Kinetic chromogenic assay (KCA)
- Gel clot assay (GCA)
- Alternative method: Factor C
- Beta D glucan test
- Sample holding time and Low Endotoxin Recovery (LER) studies
