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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...

Our History

The leading authority on CMC and regulatory consulting for biologics, cell, and gene therapies.

BioTechLogic was founded in December 2003 by former Pfizer colleagues Tracy TreDenick, Peter Dellva, and Patrick Giljum.

BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience to help clients bring their products to market quickly and successfully by augmenting and optimizing an organization’s technical, manufacturing, analytical, and regulatory resources.

Our technical expertise resides in a wide range of biotherapeutic products including gene and cell therapies, recombinant proteins, vaccines, biosimilars, synthesized macromolecules (oligonucleotides and peptides), combination drug-device products, medical devices, and blood products. Through the combined expertise and knowledge of our staff, we have developed proven methodologies and approaches for providing reliable and dependable services in the following areas:

  • Process Development and Quality by Design (QbD) including:
    • Parameter Classifications
    • Failure Mode & Effects Analysis (FMEA)
    • Design of Experiments (DOE)
    • Critical Process Parameter Evaluation
    • Parameter Justification Reports
    • Development Reports
  • Technology Implementation, Transfer and Scale-up
  • On-Site Third Party Contract Manufacturing Support
  • Analytical Method Development, Validation & Support
  • Process Validation
    • Process Performance Qualifications Protocols/Reports
    • Continued Process Verification Plans/Protocols
  • Project Management
    • Process Validation, Submission Preparation, PAI Readiness and Launch
  • Quality Assurance
    • Multi-Product Facility Audits, Pre/Post Viral Inactivation Audits, etc.
  • Regulatory Submissions
    • Briefing Packages, CTD Module 2.3 (Summaries) and 3 (Quality), and Briefing Packages
  • PAI Inspection Readiness (FDA Pre-Approval Inspection Readiness)

As workloads exceed resource capacity due to accelerated commercialization timelines and/or when objective third-party input is required to develop strategies or solve problems, BioTechLogic will provide the technical skills and personnel to fill these needs.

 

Since 2004 …

 

1,400+ projects, 257 clients

  • 73 gene therapy products
    • 3 approved
  • 26 cell therapy products
  • 76 biologically derived innovator products
    • 26 recombinant proteins
    • 18 vaccines
    • 23 antibodies
    • 9 blood-based products
  • 34 biosimilar products
  • 23 synthesized macromolecules
    • 15 oligonucleotides
    • 8 peptides
  • 35 combination products
      • 18 pre-filled syringes
      • 6 drug device delivery systems
      • 1 needle-free injector
      • 1 drug with excipient in a PFS
      • 1 novel therapeutic API for use in a fibrin sealant
  • 2 Type III medical devices
  • A variety of complex drug products with unique formulations
  • Led and provided the overall strategy for 57 Process Validation Programs, including:
    • 20 approved by the FDA and/or EMA
    • 2 submitted and in review by FDA and/or EMA
    • 9 ongoing global process validation programs
    • 6 – gene therapies, 2 – cell therapies, 7 – biosimilars, 8 – vaccines, 5 – antibodies, 11 – recombinant proteins, 1 – peptide, 1 – oligonucleotide, 2 – blood-based, 8 – drug-device combination products, 4 – other
  • Primary CMC author for 102 Submissions:
    • 48 INDs (2-antibodies, 3 – oligonucleotides, 3 – peptides, 1 – recombinant proteins, 7 – cell therapies, 1 modified particle, 23 – gene therapies, 4-biosimilars, 3 – drug-device combination products, 2-other)
    • 6 IMPDs (2 – gene therapies, 2 – vaccines, 1 – cell therapy, 1 – biosimilar)
    • 26 BLAs (4 – vaccines, 3-antibodies, 3- recombinant proteins, 3 – gene therapies, 1 – peptide, 4 – biosimilars, 6 – drug-device combination products, 1 – oligonucleotide, 1 – blood-based,
    • 3 BLAs / 315(K) (3 – biosimilars)
    • 2 NDAs (1 – peptide, 1 – oligonucleotide)
    • 7 MAAs (1 – vaccine, 1 – recombinant protein, 1- gene therapy, 1-biosimilar, 2 – oligonucleotides, 1 – fusion/protein combo)
    • 1 PMA (1 – drug-device combination product)
    • 9 CTAs, Health Canada (9 –gene therapies)
  • Major contributors to 31 approved submissions that have resulted in commercial products, including:
    • 17 FDA-approved biological products (BLAs and NDAs)
    • 6 EMA-approved biologic medicinal products (MAAs)
    • 2 EMA-approved biologic biosimilar (MAAs)
    • 1 FDA-approved drug/device combination product (NDA)
    • 4 FDA-approved small molecule products (NDAs)
    • 1 FDA-approved device (PMA)