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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...

Cell Therapy Development & Commercialization

BioTechLogic’s team of experts has deep expertise and experience working on the front lines of cell therapy development.

While much progress has been made within the cell therapy development arena, many challenges remain, including using and managing unconventional raw materials, delivery specificity, control of activity, detection of potential off-target mutations, and their inherent immunogenicity.

Complete Cell Therapy Product Lifecycle Support Services

BioTechLogic has extensive experience with all cell therapy development and commercialization aspects–-from preclinical to market.

Cell Therapy Development

Globally, several thousand cell therapy candidates are in development, many of them in early phases of development. Progressing these therapies to commercialization is challenged by manual processes, lack of product characterization, reproducibility difficulties, precise control over cell therapy activity, and immunogenicity management.

 

How BioTechLogic Can Help

    • Cell colony development
    • Product characterization
    • Analytical method development
    • Critical Quality Attributes understanding
    • Cell processing approach decision-making
    • Purification processes
    • Reproducibility
    • Process development and scale-up
    • Regulatory filing support
    • CDMO selection

Cell Therapy 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

Cell Therapy Resources

The Bustling Cell and Gene Therapy CMO Scene

The Bustling Cell and Gene Therapy CMO Scene

Pharma’s new and exciting era of targeted therapeutics has the potential to be a turning point for modern medicine. The buzz has led to a flurry of investment in the cell and gene therapy space. According to a recent Alliance for Regenerative Medicine report, nearly...

Process Validation for Expedited Approval Drugs

Process Validation for Expedited Approval Drugs

White Paper Process Validation and Regulatory Review in the Age of Expedited Approval DrugsExpedited approval drugs have profoundly changed the thinking and approach to Process Validation and other CMC activities. When working on the development of an expedited...