We provide world-class consulting services for cGMP/GLP laboratories, focusing on Analytical Methods, Laboratory Buildouts and Operations, Product and Process Quality Control, Quality Assurance, and Regulatory Compliance.
Our team of experts is ready to help you achieve your company’s strategic goals.
We offer product specific, highly customized strategies to meet your program needs:
- Drug Substance/Drug Product Quality Control
- Product Biopotency/Bioactivity
- USP/EP Compendial Assays & Sterility
- In-Process Manufacturing Control
- Device Compatibility
- Lot-to-Lot Comparability
- Raw Material Sourcing and Testing
- EMPQ and Environmental Monitoring Program Implementation
Our experts provide guidance and strategy for Analytical Development, CMC, Quality Control, and Quality Assurance for Cell & Gene Therapies throughout all stages of the product lifecycle, from early pre-clinical development through commercialization.
Analytical Methods
From USP/EP compendial assays to complex bioactivity/biopotency assays, our team provides demonstrated and effective guidance, support, and strategy on analytical method development, qualification, validation and vertification.
We can provide comprehensive end-to-end services for analytical method development, qualification and validation to meet FDA, EMA, and ICH guidelines for drug products in as little as 90 days!
USP/EP
Compendial Assays
- pH, Conductivity, Osmolality
- Sterility, including Rapid Methods
- Subvisible Particulates <787, 788, 789>
- Endotoxin, Bioburden, and more
Nucleic Acid Based Assays
- digital droplet, digital, quantitative real-time, and reverse-transcription based PCR methodologies for Advanced Cell and Gene Therapy Products
- Capillary & Gel-based Electrophoresis Electrophoresis
- Next-Generation and Sanger Nucleic Acid Sequencing
Cell-based Assays
- Infectivity Assays for Viral Gene Therapies (TCID50)
- Product Specific Bioactivity/Biopotency Assays
- Flow Cytometry, Immunophenotyping
- Cell Bank Viability and Morphology
- Plasmid Retention
- Bacteriophage Detection
Protein Assays
- Identity and Post-Translational Modification detection by LC/MS
- HPLC/UPLC for Identity, excipients quantitation, purity
- CE-SDS, SDS-PAGE, and Western Blotting
- Protein Activity, Enzyme/Substrate Turnover, etc.
MidOhio Quality Consulting 