Tailin Biotech Enzyme Series for Antibiotic Neutralization in Microbiological Testing
| Brand | Tailin Biotech |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | OEM/ODM Manufacturer |
| Product Origin | Domestic (China) |
| Model Range | Penicillinase, Cephalosporinase, Metallo-β-lactamase, Glycopeptidase, *Staphylococcus aureus*-Specific Enzyme, Macrolidase |
| Pricing | Available upon Request |
Overview
The Tailin Biotech Enzyme Series comprises a rigorously characterized portfolio of microbial enzyme reagents designed specifically for the neutralization of residual antibiotics in pharmaceutical microbiological testing. These enzymes are employed during sterility testing (per USP , Ph. Eur. 2.6.1, and ISO 11737-2) and microbial limits testing (USP , ) to eliminate antimicrobial activity that would otherwise inhibit growth of challenge microorganisms—ensuring accurate detection of viable contaminants. Each enzyme is purified from validated microbial strains and functionally titrated against defined antibiotic classes using standardized turbidimetric or agar diffusion assays. The series operates on well-established biochemical principles: β-lactamases hydrolyze the β-lactam ring; glycopeptidases cleave peptidoglycan-binding domains; and macrolidases disrupt ribosomal binding through esterase-mediated deactivation. This enables reliable, reproducible recovery of test organisms—including *Bacillus subtilis*, *Clostridium sporogenes*, *Candida albicans*, and *Aspergillus niger*—in accordance with pharmacopoeial validation requirements.
Key Features
- Pharmacopoeia-aligned enzyme specificity: Each preparation is qualified for defined antibiotic classes (e.g., penicillinase for ampicillin and piperacillin; metallo-β-lactamase for carbapenems such as meropenem and imipenem)
- Batch-to-batch consistency verified by enzymatic activity units (U/mg protein), determined via spectrophotometric kinetics at 25 °C and pH 7.0–7.4
- Lyophilized formulation with validated shelf life of ≥24 months at –20 °C; reconstituted solutions stable for 7 days at 2–8 °C
- Endotoxin content ≤0.5 EU/mL (LAL assay, USP ) and absence of viable microbial contamination (membrane filtration, USP ) confirmed per batch
- Supplied with Certificate of Analysis (CoA) including specific activity, purity (SDS-PAGE), residual host cell proteins, and sterility test results
Sample Compatibility & Compliance
These enzymes are compatible with common pharmaceutical dosage forms—including aqueous solutions, lyophilized powders, ointments, and suspensions—when incorporated into membrane filtration or direct inoculation methods. They meet the technical prerequisites for use in GLP- and GMP-regulated environments, supporting compliance with FDA 21 CFR Part 11 (when used within validated electronic lab notebook or LIMS workflows), EU Annex 1 (sterile manufacturing), and ICH Q5C (stability of biological reagents). All enzymes undergo verification per USP “Validation of Microbial Recovery” and support validation protocols required under ISO 13485 for in vitro diagnostic reagent manufacturers.
Software & Data Management
While the enzymes themselves are non-instrumental reagents, Tailin Biotech provides digital documentation packages compatible with regulated quality systems. Each CoA is issued in PDF/A-1b format with embedded digital signatures compliant with eIDAS standards. Batch records, stability data, and retest date calculations are structured to integrate with commercial QMS platforms (e.g., Veeva Vault QMS, MasterControl) and support audit readiness for FDA pre-approval inspections or MHRA surveillance audits. Traceability includes unique batch numbers linked to raw material sourcing, purification logs, and third-party analytical reports.
Applications
- Sterility testing of β-lactam antibiotics, cephalosporins, carbapenems, glycopeptides (e.g., vancomycin), and macrolides (e.g., erythromycin, azithromycin)
- Microbial enumeration of antibiotic-containing ophthalmic, otic, and topical formulations per USP
- Method suitability testing for new drug product submissions to regulatory agencies (FDA, EMA, NMPA)
- Neutralization control in environmental monitoring programs for aseptic processing facilities
- Reference standard preparation in collaborative studies evaluating alternative neutralization strategies (e.g., resin-based adsorption vs. enzymatic inactivation)
FAQ
How is enzyme activity quantified for each batch?
Activity is measured in international units (U), defined as the amount of enzyme catalyzing the hydrolysis of 1 µmol of substrate per minute under specified conditions (temperature, pH, substrate concentration). Results are reported as U/mg protein alongside kinetic parameters (Km, Vmax) where applicable.
Can these enzymes be used in combination for multi-class antibiotic products?
Yes—combination use is supported when justified by risk assessment and validated per USP . Tailin provides compatibility matrices and co-incubation stability data for common pairings (e.g., penicillinase + glycopeptidase).
Do you supply pre-qualified enzyme blends for specific pharmacopoeial monographs?
Tailin offers custom-blended formulations aligned with USP monographs for ceftazidime, ceftriaxone, and teicoplanin, subject to client-specific validation support agreements.
What documentation accompanies each shipment?
Each lot includes a Certificate of Analysis, Certificate of Origin, SDS (GHS-compliant), and a Statement of Regulatory Conformance confirming alignment with ICH Q5A(R2) and WHO TRS No. 1016 Annex 4 requirements.
