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.
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 900 different projects with 160+ different clients.
- 58 different biologically derived innovator products, including 21 recombinant proteins,14 vaccines, 14 antibodies (including 2 ADCs), and 9 blood based-products.
- 26 biosimilar products.
- 20 synthesized macromolecules, including 13 oligonucleotides and 7 peptides.
- 18 combination products, including 12 pre-filled syringes,1 needle free injector, 3 drug device delivery systems, 1 novel therapeutic API for use in a fibrin sealant, and 1 drug with excipient in a PFS.
- 19 gene therapy products and 6 cell therapy products.
- 1 Type III medical device.
- A variety of complex drug products with unique formulations.
- We have led and provided the overall strategy for 30 Process Validation Programs, including:
- 17 approved by the FDA and/or EMA
- 2 submitted and in review by FDA and/or EMA
- 11 on-going global PV programs
- We have been major contributors to 26 approved submissions that have resulted in commercial products, including:
- 15 FDA approved biological products (BLAs and NDAs)
- 3 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)
- We have served as the primary CMC author for 33 Submissions:
- 11 INDs (4 – biologic, 1 – oligonucleotide, 1 – cell therapy, 1 modifiedparticle, 4 – gene therapy)
- 3 IMPDs (1 – biologic and 2 – vaccine)
- 9 BLAs (4 – vaccine, 1 – blood product, 2 – antibody fragments, 1 – gene therapy, and 1 – fusion protein / combo product)
- 1 BLAs / 315(K) (1 – biosimilar)
- 2 NDAs (1 – well characterized biologic with autoinjector and 1 – small molecule in drug delivery system)
- 6 MAAs (1 – vaccine, 1 – recombinant protein, 2 – antibody fragments, 1 – fusion protein / combination product, 1 – biosimilar)
- 1 PMA (sterile protein; Type III Medical Device)