Process Quality Study & Validation Services
Biologics Testing & Analysis
Testing for recombinant proteins, antibodies, cell culture media, biological reagents and microbiology-related products.
Integración producto-servicioProcess Quality Study & Validation Services
Alcance
Alcance
Testing data, validation documents and third-party review across material development, scale-up, production QC, filing and audit workflows.
Protein purity, molecular weight, molecular interaction and residual nucleic acid
Microbial limits, sterility, endotoxin and bioburden
Sample receipt, testing, reporting and retest workflow
Alcance del servicio
Biologics Testing & Analysis
Testing for recombinant proteins, antibodies, media, biological reagents, microbial strains and diagnostic raw materials to confirm bioactivity, purity, safety and lot consistency.
Protein purity, molecular weight, molecular interaction, expression level and residual host protein/nucleic acid testing
Protein purity, molecular weight, molecular interaction, expression level and residual host protein/nucleic acid testing
Sterility, microbial limits, endotoxin, bioburden and mycoplasma testing
Sterility, microbial limits, endotoxin, bioburden and mycoplasma testing
Quality review for media, sera, enzymes, antibodies, kits and diagnostic raw materials
Quality review for media, sera, enzymes, antibodies, kits and diagnostic raw materials
Sample receipt, retention, retest, report archiving and third-party endorsement
Sample receipt, retention, retest, report archiving and third-party endorsement
Proceso
Service Process
- 01
Testing plan based on product purity, activity, safety and contamination risks
- 02
Sample receipt and retention with lot, transport condition, quantity and retest plan
- 03
Physicochemical, biochemical, microbiology and molecular testing with review
- 04
Report archive with test report, raw-record summary, exception notes and retest suggestions
Casos seleccionados
Casos típicos
Entrega organizada por escenarios reales, desde suministro y documentos hasta validación y ensayos.
01
Media and serum review for sterility, endotoxin, mycoplasma and key performance indicators
Media and serum review for sterility, endotoxin, mycoplasma and key performance indicators
02
Diagnostic raw material qualification for antigens, antibodies, enzymes and buffers
Diagnostic raw material qualification for antigens, antibodies, enzymes and buffers
03
Bulk biologic reagent confirmation with consistency retesting after sample approval
Bulk biologic reagent confirmation with consistency retesting after sample approval
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