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, practical, and 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)
- Parameter Classifications
- Failure Mode & Effects Analysis (FMEA)
- Design of Experiments (DOE)
- Critical Process Parameter Evaluation
- Parameter Justification Reports
- Development Reports
Regulatory Submissions
- Briefing Packages, CTD Module 2.3 (Summaries) and 3 (Quality), and Briefing Packages
Technology Implementation, Transfer and Scale-up
Analytical Method Development, Validation & Support
Project Management
- Process Validation, Submission Preparation, PAI Readiness and Launch
PAI Inspection Readiness
- (FDA Pre-Approval Inspection Readiness)
On-Site Third Party Contract Manufacturing Support
Process Validation
- Process Performance Qualifications Protocols/Reports
- Continued Process Verification Plans/Protocols
Quality Assurance
- Multi-Product Facility Audits, Pre/Post Viral Inactivation Audits, etc.
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 …
Years
Consultants
Clients
projects
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
3 BLAs / 315(K)
- 3 biosimilars
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
2 NDAs
- 1 peptide
- 1 oligonucleotide
9 CTAs, Health Canada
- 9 gene therapies
7 MAAs
- 1 vaccine
- 1 recombinant protein
- 1 gene therapy
- 1 biosimilar
- 2 oligonucleotides
- 1 fusion/protein combo
2 NDAs
- 1 peptide
- 1 oligonucleotide
1 PMA
- 1 drug-device combination product
76 biologically derived innovator products
- 26 recombinant proteins
- 18 vaccines
- 23 antibodies
- 9 blood-based products
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
A variety of complex drug products with unique formulations
73 gene therapy products
- 3 approved
Major contributors to 31 approved submissions that have resulted in commercial products
- 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)
34 biosimilar products
26 cell therapy products
23 synthesized macromolecules
- 15 oligonucleotides
- 8 peptides
Led and provided the overall strategy for 57 Process Validation Programs
- 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
