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CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs...

Biosimilars Development & Commercialization

BioTechLogic’s team of experts has broad experience working on the front lines of biosimilar development.

The biosimilars market only first began in the early 2000’s. Advancing analytical and characterization technologies, legislative and regulatory support within leading global markets, biosimilar development experience, and a second biologics patent cliff, have positioned the sector for growth.

Complete Biosimilars Product Lifecycle Support

BioTechLogic has extensive experience with biosimilar development and commercialization, from preclinical to market. Through more than 32 biosimilars projects, we have the experience and the expertise to help.

Biologics Characterization & Analytical Understanding

Understanding which critical quality attributes (CQAs) deliver the needed therapeutic performance and safety profiles is essential for a successful biosimilar program. Thorough product characterization and understanding, driven by strategic and effective analytical strategies, are essential.

 

How BioTechLogic Can Help

    • Product characterization
    • Analytical method development & strategies
    • Critical Quality Attributes understanding
    • Purification processes
    • Reproducibility
    • Upstream process development and scale-up
    • Downstream process development & scale-up
    • Regulatory filing support
    • CDMO selection

Biosimilars CMC Services

CMC Strategy

Quality Assurance

Analytical Services

Regulatory Consulting & Submissions Support

Process Development & Validation

Contract Services & Tech Transfer Support

Supply Chain Management

Inspection Readiness

Project Management

Years of Experience

Consultants

Clients

projects
Opportunities and Challenges in Biosimilar Development

Opportunities and Challenges in Biosimilar Development

A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product. Unlike generic small molecules, it is difficult to standardize such inherently complex products based on complicated...

Biosimilars Face Repercussions of Drug Pricing Debate

Biosimilars Face Repercussions of Drug Pricing Debate

As more biosimilars gain FDA approval for marketing in the United States, and more manufacturers launch programs to develop additional competitive biotech therapies, concerns have emerged that continued growth in this area could be limited by mounting pressure to push...