Empowering Biologics with Definitive Biosafety & Contract Testing Solutions.
GMP-compliant analytical validation and adventitious agent screening to accelerate your recombinant proteins, vaccines, and advanced therapies from discovery through commercial lot release. Every patient has the right to a safe drug.
Fully classified testing zones with unidirectional airflow, dedicated sample intake airlocks, and validated electronic chain of custody (eCoC).
Comprehensive Biosafety Solutions Across 5 Critical Modalities
Each therapeutic classification poses distinct viral contamination risks and regulatory clearance prerequisites. Explore our custom qualification pathways aligned to global pharmacopeias.
Recombinant Monoclonal Antibodies, Biosimilars & Fusion Enzymes
Rodent cell lines (CHO, NS0, Sp2/0) inherently harbor endogenous retrovirus-like particles (RVLPs). SafeCell provides precise quantification, in vitro adventitious virus screening, and validated downstream log-reduction factor (LRF) determinations.
- • Endogenous RVLP Quantification (TEM & qPCR)
- • In Vitro Adventitious Virus Screen (3 Cell Lines)
- • Downstream Viral Clearance Validation (PPV, X-MuLV)
- • Unprocessed Bulk Harvest (UPB) Release Testing
- • ICH Q5A(R2) Clearance Expectations (>12-16 LRF overall)
- • Ph. Eur. 5.2.3 • US FDA Points to Consider
- • Master & Working Cell Bank Full Testing Lot Release
Downstream Viral Clearance Studies: Scaled-Down Spiking & Recovery
SafeCell partners with process development teams to validate the viral clearance capacity of chromatography, low pH holds, solvent/detergent treatment, and virus filtration. Our dedicated viral spiking cleanrooms ensure absolute quarantine between virus propagation and customer downstream matrices.
PPV, X-MuLV, PRV, Reo-3, and BVDV grown to high titer (>10^8 TCID50/mL).
Validated TCID50, plaque assay, and large volume plating (LVP) for statistical confidence.
Complete regulatory study reports formatted for IND, BLA, and MAA Module 3 filings.
16 Core Testing Programs & Analytical Assays
Conducted under strict cGMP protocols within BSL-II containment suites with independent QA oversight.
Mammalian Cell Banking
Full MCB & WCB qualification: isoenzyme identity, viability, karyology, and absence of adventitious agents.
Microbial Cell Banking
Bacterial (E. coli) & yeast host characterization: colony morphology, phage screening, and antibiotic marker verification.
Viral Bank Qualification
Master & Working Virus Seed Stock testing for titer, identity, sterility, mycoplasma, and adventitious viral contaminants.
Unprocessed Bulk Testing
Routine lot-release adventitious virus detection in harvest bioreactor broths via multi-indicator cell cultures.
Viral Clearance Validation
Downstream unit operation challenge studies: chromatography, nanofiltration, and low pH hold virus log reduction factor (LRF).
Raw Material Testing
Screening bovine sera, porcine trypsin, and growth supplements for BVDV, PPV, BAV, and specific porcine/bovine agents.
Genomic & Vector Sequencing
Next-generation biosafety sequencing (NGS) for unbiased virus detection and viral vector genome integrity verification.
Antiviral & Neutralization
Custom in vitro neutralization titers (PRNT), virucidal activity verification, and compound antiviral efficacy screening.
Sterility Testing (DS / DP)
14-day membrane filtration and direct inoculation pharmacopeial sterility testing in cleanroom isolators.
Vaccine Lot Release Testing
Potency, residual host protein/DNA, identity, endotoxin, and absence of extraneous viral contaminants.
TEM Ultrastructural Assay
Transmission Electron Microscopy visualization for direct enumeration of A-type, B-type, C-type, and D-type retrovirus particles.
Mycoplasma Testing
28-day agar/broth culture, Vero indicator cell DNA staining, and validated fast 48-hour NAT/qPCR testing.
Bioburden & Endotoxin
Quantitative bacterial endotoxin test (LAL Kinetic-Chromogenic) and microbial enumeration test on in-process intermediates.
Quantitative Real-Time PCR
Custom primer-probe design and validated TaqMan qPCR assays for specific viral loads and residual host cell genomic DNA.
Genetic Stability Studies
Plasmid retention, restriction endonuclease mapping, copy number analysis, and Sanger sequencing of master vs end-of-production cells.
Method Development & Validation
Protocol drafting, matrix interference evaluation, spiked recovery, and full validation under ICH Q2(R1) guidelines.
Dedicated Cell & Virus Banking Vault Infrastructure
SafeCell provides redundant, continuous 24/7 monitored cryogenic storage with segregated quarantine zones for uncharacterized, master, and working banks.
Cell Bank Production & Cryopreservation
cGMP-compliant single-use manufacturing of Master (MCB) and Working Cell Banks (WCB) up to 500 vials per batch in classified Grade B/A cleanrooms.
Virus Bank Manufacturing
Propagation and titering of Master Virus Seeds (MVS) and working stocks for vaccine manufacturers and challenge test models with verified identity.
Strategic Biosafety Consultancy
Direct engagement with veteran study directors to structure viral clearance filings, mitigate adventitious findings, and prepare regulatory responses.
4-Step Transparent Study Execution
Every contract testing project adheres to strict chain-of-custody protocols from initial quote to final audited study dossier.