Quality assurance and control

Why are QA and QC important?

QA and QC steps are essential in biologics development and manufacturing for determining the safety, efficacy and consistency of drug products.

QA and QC testing can help across many aspects of your journey to market, including:

• Safety: Identifying potential contaminants, impurities and other hazards helps to ensure that biologics are safe for patients
• Efficacy: Testing for the ability to produce the desired therapeutic effect helps to demonstrate overall efficacy
• Consistency:  Ensuring that biologics are consistent during development and manufacturing is important so that patients always receive the same high-quality products
• Regulatory compliance: Biologics must comply with regulatory requirements, including standards set by regulatory agencies such as the FDA and EMA
• Patient trust: Showing that products are safe, effective and consistent helps to build patient trust in biologics
• Cost-effectiveness: Preventing the release of defective products and avoiding product recalls helps to reduce overall costs

Understanding our QA and QC capabilities

We offer end-to-end QA and QC capabilities to support your biologics development and manufacturing, including:

• Compliance: Quality management systems (QMS), certificate of analysis (COA) services, audit compliance, documentation, training, qualification and validation
• Bioassays: Potency batch testing, clinical sample testing for pharmacokinetics and immunogenicity
• Method validation: Analytical, potency assays, pharmacokinetics, immunogenicity, cleaning method
• Instrumentation: In-process analysis, batch testing (content, purity/impurity, plate-based assays)
• Raw material and packaging material :Release of material, excipient testing, water testing
• Microbiology: Bioburden, sterility and BET, environmental monitoring, water testing, gowning qualification
• Ancillary: Sample, stability and reference standard management