Genemed has 20 years of PCR IVD contract manufacturing experience (FDA Registered and ISO 13485:2003 Certified).
We offer development and formulation of finished positive control components according to your specification. Our document control process creates and maintains your documentation, including production batch records, testing procedures, and acceptance criteria. Our QST and ISO compliant facility and operation strictly adhere to your quality requirements.
Following is a sample flow chart for service case study for positive control manufacturing service
Analytical Test Details
Identity:
Plating and growth on non-selective and selective medium, Gram stain
Restriction enzyme mapping and DNA sequence anaylysis
Purity:
Single clone selection on selective medium
OD of 268/280 ratio; restriction enzyme digestion and gel electrophoresis
Viability:
Plating and growth on selective medium
Standard plate count
Plasmid retention test
Roche Molecular Systems:
To learn more about why Roche Molecular Systems trusts Genemed's manufacturing services, please email us
