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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...

Antibody Therapeutic Development & Commercialization

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

The development of a successful antibody-based therapeutic requires the identification and creation of a selective and potent molecule that performs the needed action, humanization of sequences, affinity maturation, engineering to modulate effector functions, and addressing biophysical challenges that would negatively impact manufacturability and/or patient effectiveness.

Complete Antibody Therapy Product Lifecycle Support Services

BioTechLogic has extensive experience with antibody therapy development and commercialization, from preclinical to market. Whether choosing an antibody with the desired affinity and specificity for an antigen target, engineering an antibody to do the job, or selecting the appropriate expression system, we are here to help.

Antibody Development & Production

BioTechLogic has extensive experience supporting the development and production of monoclonal antibodies (mAbs), bispecific antibodies, antibody fragments, radiolabeled antibodies, antibody conjugates (ADC’s), and more.

 

How BioTechLogic Can Help

    • Expression system selection
    • Product characterization
    • Analytical method development
    • CDMO selection
    • Critical Quality Attributes understanding
    • Purification processes
    • Reproducibility
    • ADC conjugation development / optimization
    • Upstream process development and scale-up
    • Downstream process development and scale-up
    • Regulatory filing support

Antibody Therapeutics 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

Antibody Therapeutic Resources

mAbs and Their Therapeutic Evolution

mAbs and Their Therapeutic Evolution

White Paper mAbs and Their Therapeutic EvolutionBy Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant Monoclonal antibodies (mAbs) elegant specificity has catapulted them to a starring role within the world of precision medicine over the course of...

The Evolution of Therapeutic Monoclonal Antibodies

The Evolution of Therapeutic Monoclonal Antibodies

By Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant, BioTechLogic The elegant simplicity of monoclonal antibodies (mAbs) has catapulted them to a starring role within the world of precision medicine over the course of the last couple of decades....