Our History

BioTechGraphic

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

The Biopharma group that these founders supported was responsible for management of a virtual supply chain and had to assure biopharmaceutical supplies, manage third party contract manufacturers, negotiate contracts, and provide technical and submission support to develop the manufacturing and regulatory documents that would support global drug submission and approval. When Pfizer closed the former Searle Chicago Site in 2003, these colleagues saw an opportunity to provide a valuable service. Many of BioTechLogic’s employees share this same history.

About Us

BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps 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 biological and oligonucleotide products including recombinant proteins, vaccines 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
  • BioAnalytical Services
  • 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 …

  • Over 500 different projects with 75+ different clients.
  • We have supported 32 different biologically derived compounds, including 14 recombinant proteins, 8 vaccines, 7 antibodies, 3 blood based-products, and 2 fusion proteins.
  • 7 biosimilar compounds.
  • 10 synthesized macromolecules, including 7 oligonucleotide and 3 peptide projects.
  • 9 combination products , including 6 pre-filled syringes, 1 needle free injector, and 2 drug delivery device systems.
  • 2 gene therapy products.
  • 1 Type III Medical Device .
  • We have led 21 Process Validation Programs, including:
    • 10 approved by the FDA and EMA
    • 5 submitted and in review by FDA and/or EMA
    • 6 on-going global PV program
  • We have been major contributors to 14 approved submissions that have resulted in commercial products, including:
    • 5 FDA approved biological products (3 BLA and 2 NDA)
    • 3 EMA approved biologic medicinal products (MAAs)
    • 1 EMA approved biosimilar (MAA)
    • 1 FDA approved drug/device combination product (NDA)
    • 4 FDA approved small molecule products (NDAs)
  • We have served as the primary CMC author for 24 Submissions:
    • 5 INDs (4 biologic and 1 oligonucleotide)
    • 3 IMPD (1 biologic and 2 vaccine)
    • 6 BLAs (2 vaccine, 1 blood product, 2 antibody fragments, 1 – fusion protein/combination product)
    • 2 NDAs (1 well characterized biologic and 1 small molecule in drug delivery system)
    • 6 MAAs (1 vaccine, 1 recombinant proteins, 2 antibody fragments, and 1 – fusion protein/combination product)
    • 1 PMA (1 sterile protein; Type III Medical Device)