Combination Products

BioTechLogic, Inc. assists medical device and biopharmaceutical companies by providing Process Validation, Regulatory Affairs, Quality Assurance, Process Development, Quality by Design (QbD), Design Controls, Project Management, and Bioanalytical services supporting their combination products.

The following are examples of the services offered by BTL to help support combination products throughout product development and into commercialization.

Process Validation

  • Pre-Qualification Activities: Establishment of Critical Process Parameters, Controls and Functional Requirements
  • Equipment Qualification Protocols and Reports
  • Process Validation Protocols and Reports
  • Evaluation and/or Statistical Analysis of data generated during PV Campaign

Regulatory Affairs

  • Provide advice on regulatory pathways associated with US and EU submissions
  • Liaise with FDA, Notified Bodies, and Competent Authorities
  • Generate and review the Chemical, Manufacturing, and Controls (CMC) section of regulatory submissions (e.g., IND, IMPD, NDA, BLA, PMA, MAA, Design Dossier, supplements and amendments) and ensure that all current regulations and guidelines are met

Quality Assurance

  • Establish new quality management systems in accordance with Current Good Manufacturing Practices (21 CFR 210/211), Quality System Regulations (21 CFR 820), Medical Device Directives 93/42/EEC, ISO13485, ISO9001, European Good Manufacturing Practices, as well as hybrid combination product systems
  • Perform gap assessments of existing quality management systems to meet new or revised regulatory requirements
  • Quality System Mapping and Quality Planning for products, gaps in the quality system, or transitions to new regulatory requirements
  • Provide on and off-site quality system support including reviewing documentation, generation of system procedures and forms, corrective and/or preventive action recommendations, management review system and Training
  • Perform internal and external audits including FDA/Notified Body Inspection Readiness and Mock Inspections
  • Assess suppliers for the implementation of combination product quality system requirements
  • Assist with Design Controls, Design History Files, and Device Master Records

Process Development, Quality by Design, and Design Controls

  • Detailed Process Descriptions
  • Development Reports
  • Technology and Design Transfer
  • Manufacturing Process Troubleshooting
  • Campaign Summary Reports
  • Contract Site Management
  • On-Site Manufacturing Support
  • Design Change Impact Assessment
  • Comparability Protocols
  • Engineering Run Protocols

Project Management

  • Develop detailed plans and schedules (manufacturing and components)
  • Develop project communication plans and matrices
  • Highlight critical project issues and risks, and facilitate the development of mitigation action plans
  • Plan, facilitate and conduct team meetings
  • Manage the organization and storage of project documents

BioAnalytical

  • Hands-on or consultancy services for methods that require development, qualification or validation and are intended to be used in the support of characterization, profiling, validation or product release activities for intermediates, drug substance or drug product.

BioTechLogic – Product Experience Summary

  • Our Company experience includes 183 different projects with 33 different clients.
  • We have supported 16 biologically derived compounds, examples include 3 vaccines, 3 antibodies, and 1 blood based-product.
  • We have collaborated on 7 synthesized macromolecules, including 5 Oligonucleotide and 2 peptide projects.
  • We have supported 2 small molecule compounds, including a solid oral dosage and a parenteral.
  • Our team members’ Medical Device experience includes:
  • Synthetic augmented bone graft
  • Bone screws, surgical blades, reusable surgical instruments
  • Medical grade liquid silicone
  • Enteral Nutritional Feeding Pumps
  • Pre-Filled Heparin Lock Flush
  • Normal Saline IV Flush Syringes
  • Coated medical devices, including adhesive laminating, adhesive bonding, coatings, and sealant products
  • Synthetic augmented bone graft with recombinant human platelet-derived growth factor
  • HBsAg, HCV, and HIV-1/HIV-2 Diagnostic Test Kits (Blood Donor Screening)
  • BioTechLogic’s Drug/Device Combination Product experience includes:
  • Pre-filled, single-use, needle-free drug delivery system
  • Anti-bacterial mesh envelope coated with bioresorbable polymer and antibiotics
  • Biocompatible protein backbone crosslinked with polyethylene glycol (PEG)