Biologics Analytical Services to Drive CMC Development

Biologics Analytical Services for CMC Development

Biologics analytical services are a critical component of any drug development program. From early characterization through GMP release testing, the analytical data you generate at each stage shapes regula

Referetory submissions and product timelines.

Pharmaron is a trusted partner in analytics, offering deep expertise and flexible solutions that support every phase of your project. From method development to regulatory-compliant testing, we ensure your biologic is thoroughly characterized, safe, and market-ready.

Offering both complete end-to-end solutions or targeted expertise for specific analytical challenges for your innovator or biosimilar product, our adaptable approach ensures your project’s success.

Our Benefits:

• Flexibility: Candidate Selection, Tech Transfer, and Pre-submission prep
• Extensive Expertise and Comprehensive Analytical Characterization in Line with ICH Guidelines
• Optimized Platform Methods for Consistent and Reproducible Results
• Tailored Analytical CMC Solutions for Biologics Characterization
• Regulatory Confidence in Submissions for Release Testing of GMP DS and DP

View this brochure for our full analytical service packages, including platform methods, testing categories, and how Pharmaron structures support across preclinical through commercialization.

References:

• Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics
• ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products