aGMP Grade
Akron Bio’s high-quality GMP-like grade is designed for gene therapy companies & early clinical programs
We produce aGMP-grade materials utilizing equipment and processes scalable to full GMP standards. Our facilities provide flexibility for small to large-scale production, ensuring ISO-validated environments and adherence to most cGMP requirements. aGMP is the perfect middle ground material for early-stage programs and gene therapy start-ups as it offers near-GMP quality without the added cost.
Details:
- Robust process optimization to achieve desired critical quality attributes while maximizing yield
- Manufactured in a segregated, ISO-qualified, and maintained environment
- Defined critical process parameters (temperatures, times, agitation rates, etc.)
- Up to 50 L fermenters for production
- Full-scale engineering and process validation capabilities to enable cGMP production
- Procurement and management of cGMP-grade materials sourced from approved suppliers
- Stability Studies (Upon Request)
- Final summary report
• Viability determination (Cell Titer)
• Cell bank purity (Plating on TSA and SDA)
• Host species identity (16S rDNA sequencing)
• Antibiotic sensitivity (CFU determination on multiple antibiotic and antibiotic-free plates)
• Detection of lytic bacteriophage (COA)*
• Detection of lysogenic bacteriophage (COA)*
• Host strain genotype or Plasmid Mapping (Verification of at least 3 genetic markers)*
• Plasmid retention (CFU determination on multiple antibiotic and antibiotic-free plates)*
• Plasmid identity (Sanger sequencing)*
*Out-sourced
• Appearance (USP <790>)
• Purity Ratio (A260/A280 by UV spectrophotometry)
• Concentration (USP <857>)
• % DNA Supercoiled (Densitometry)
• Purity Ratio (A260/A280 by UV spectrophotometry)
• Restriction digest (Fragment analysis by restriction enzyme mapping)
• Plasmid Identity (Size by Agrose gel electrophoresis)
• Plasmid Sequencing* (Sanger Sequencing)
• Residual host genomic DNA (qPCR)
• Residual host cell protein (ELISA)
• Residual host RNA (Fluorescence)
• Endotoxin (Kinetic chromogenic LAL)
• Sterility (USP <1071> or USP <71>)
• pH (USP <791>)
• Mycoplasma* (RT-PCR)
*Out-sourced
• Viability determination (Cell Titer)
• Cell bank purity (Plating on TSA and SDA)
• Host species identity (16S rDNA sequencing)
• Antibiotic sensitivity (CFU determination on multiple antibiotic and antibiotic-free plates)
• Detection of lytic bacteriophage (COA)*
• Detection of lysogenic bacteriophage (COA)*
• Host strain genotype or Plasmid Mapping (Verification of at least 3 genetic markers)*
• Plasmid retention (CFU determination on multiple antibiotic and antibiotic-free plates)*
• Plasmid identity (Sanger sequencing)*
*Out-sourced
• Appearance (USP <630>)
• Concentration (USP <857>)
• Identity (Western Blot)
• Purity
• Aggregation
• Activity, in vitro
• Residual host cell protein (ELISA)
• Residual DNase (Fluorometric)
• Residual RNase (Fluorometric)
• Endotoxin (Kinetic chromogenic LAL)
• Bioburden (USP <61>)
• Sterility (USP <1071> or USP <71>)
• Mycoplasma* (RT-PCR)
*Out-sourced