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...

Gene Therapy Development & Commercialization

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

The path to gene therapy commercialization is often uncharted, fraught with product characterization, viral vector development, process development, and manufacturing challenges.

Complete Gene Therapy Product Lifecycle Support Services

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

Viral Vector Development & Production

Viral vectors, including retrovirus, adenovirus, adeno-associated virus (AAV), and herpes simplex virus, have evolved to become highly efficient nucleic acid delivery vehicles. However, there are often challenges at every stage of a viral vector’s life cycle.


How BioTechLogic Can Help

    • Production system selection
    • Product characterization
    • Analytical method development
    • Purification processes
    • Reproducibility
    • Critical Quality Attributes understanding
    • Process development and scale-up
    • Regulatory filing support
    • Vector CMO partner selection and management

Gene 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






Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle

Process Development & Contract Services Decision Making

This guide helps give gene therapy innovators a high-level perspective on the process development and contract services selection decisions to be made throughout the phases of development.

Gene Therapy Resources

Strengthening Your Gene Therapy Process Control Strategy

Strengthening Your Gene Therapy Process Control Strategy

WEBINAR ON-DEMANDStrengthening Your Gene Therapy Process Control StrategyGiven the incredible diversity of gene therapy product characteristics, there is no “one solution fits all” process control toolbox to assure consistent, quality product. Manufacturers of some...

A Guide to Integrating QbD in Gene Therapy CMC Programs

A Guide to Integrating QbD in Gene Therapy CMC Programs

Cell and gene therapies have a potential, unlike anything we've ever seen before in medicine. With the power to deliver curative relief to patients suffering from debilitating conditions — many of which have no treatment options — the cell and gene therapy field is...

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...

The High Bar for Gene Therapy CMC

The High Bar for Gene Therapy CMC

White Paper The High Bar for Gene Therapy CMCHow drug developers can step up to meet regulatory expectations for gene therapy chemistry manufacturing and controls. After well publicized stumbling blocks in the late-90s, vigor was restored to the gene therapy field in...