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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...

Contract Services & Tech Transfer Support

Many biotherapeutic developers require contract service partners at various stages of the product lifecycle, and an increasing number of entirely virtual innovator organizations contract all development and manufacturing services.

BioTechLogic works with innovator clients to find the right contract services partners, support the development of a scope of work, assemble an initial vendor assessment questionnaire, coordinate and/or join facility tours, and support any needed tech transfer.

Contract Service Organizations Commonly Needed

Biotherapeutic organizations are best served by having a well-defined picture of the contract services they need throughout their product’s entire lifecycle.

Below we provide an overview of the essential work that must be conducted and the resources required at various product lifecycle stages.

Pre-IND

    • Product development/ formulation development laboratory
    • Analytical laboratory(ies) for product characterization
    • Preclinical contract research organization (CRO) for IND-enabling in vitro, in vivo, and possibly ex vivo studies

Phase I – III

    • GMP contract manufacturing facility*
    • Analytical laboratory(ies) for product characterization
    • Contract testing laboratory for stability testing
    • Quality and regulatory guidance and support
    • Clinical trial study and protocol development services
    • Clinical CRO to manage and conduct clinical trials
    • GMP storage facility for storage and distribution of clinical trial material

Commercial

    • Commercial-scale CDMO
    • Analytical laboratory(ies) for product characterization
    • Contract testing laboratory for stability sampling and testing
    • Quality and regulatory guidance and support
    • Fill-finish capabilities
    • Commercial packaging and labeling
    • Warehousing and distribution partners

Phase IV

    • Clinical CRO to manage and conduct the post-marketing studies
    • GMP storage facility for storage and distribution of clinical trial material for post-marketing studies
    • Data management and analysis partner

*GMP is not required for Phase I; however, manufacturing controls must still be in place, and the process must be adaptable to GMP for the transition to Phase II.

Contract Services Partner Selection Support

BioTechLogic supports our clients’ contract services selection decisions– picking a contract development and manufacturing organization (CDMO) is typically the most significant choice. CDMO selection is unique for every client, so we assist based on specific project objectives and circumstances. The contract services landscape continually evolves, but we work hard to stay abreast of emerging facilities and have worked with many existing players.
CDMO selection should include many factors, including:

  • Required process development assistance
  • Tech transfer costs
  • CDMO capacity needed

Collaborating with Contract Services Partners to Optimize Processes

BioTechLogic works with its innovator partners and their contract services partners to optimize processes or help to resolve issues within a manufacturing process.

  • We often join our clients on-site or fully serve as their representative
  • Improve study designs
  • Create gap assessments
  • Generating failure modes and effects analysis (FMEA)
  • Comprehensive risk assessments

Reducing Tech Transfer Risks

Although it is ideal to select a CDMO partner that can manage and execute a program throughout the product lifecycle, sometimes that is simply not possible as innovator’s needs change throughout the phases of development.

For both early phase development and transfers to facilitate larger scale production, we manage each tech transfer project by:

  • Evaluating any needed process improvement adjustments
  • Identifying opportunities to speed time to market
  • Assessing cost reduction opportunities
  • Strictly managing timelines.

Most importantly, we sharply reduce risks by expertly managing tech transfer projects, ensuring all quality systems and essential protocols remain intact or are strategically improved.

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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.