In manufacturing positive controls for PCR, the risk of contaminating the other reagents in the assay can be overwhelming. Allow Genemed to manufacture your PCR positive control for you, because our well-designed personnel flow, material flow, and process flow procedures mitigate the risk of cross-contamination. Genemed can adopt your process for manufacturing the positive control, or our expert staff can help design a process with you. When Genemed produces your positive control, there is no possibility of the positive control contaminating any of the other reagents in the assay.
Genemed can manufacture and aliquot any other PCR components for you, including buffers, dNTPs, primers, master mixes, etc in an area separate from the location where the PCR Positive Controls are formulated and dispensed. Our extensive cleaning and monitoring of our facilities prevents cross-contamination problems.
Genemed's PCR Positive Control and Component Manufacturing service includes formulation, testing, filling, label control, inspection, and shipping.
Formulation
We can formulate any aqueous phase reagent from a few hundred milliliters up to several hundred liters
Your team can decide the exact components required for your specific assay, kit, or reagent including buffering ingredients, carrier proteins, carrier DNA, detergents, and preservatives
Reagents can be filtered to remove particulates
Positive control PCR reagents can also be diluted from a high copy number solution down to a target copy number specific to your assay
Formulation can be performed in the cleanroom environment as required
Testing
• We can perform testing per your standard operating procedures
All QC personnel receive extensive proficiency training prior to each project
For positive control manufacturing, testing is performed by copy number determination through PCR
We ensure final bulk solution meets positive control specification prior to filling
We perform both End-Point PCR and Real Time PCR assays
Sample preparation and testing areas are separate to avoid contamination of test samples and to ensure accurate test results
Filling
Various filling methods are utilized at Genemed to meet your product needs
Automated filling and capping occurs in Cleanroom suites
o Fill up to 45,000 vials per day
o Fill from 100 ml to 2 ml per vial
Manual filling is performed with micropipettes, repeaters and peristaltic pumps and is performed in Laminar flow hoods
o Manual filling for any volume from the microliter range to several liters
Labeling, Label Control, and Inspection
Label design, label printing, and label application are all performed by trained personnel
Label reconciliation process in place to ensure all unused labels are accounted for and destroyed
Up to 7000 vials per hour can be labeled on two separate machines
Vial inspections are performed for all critical and noncritical defects
o No/ Low Fill
o Crooked/ Loose Cap
o Label legibility
o Damaged Vials/Caps
Packaging, Shipping, and Handling
We can perform product lyophilization as required
Products can be stored in validated, temperature-controlled areas ranging from room temperature (15-25°C), 2-8°C, -20°C, or -70°C
Shipping validations can be performed as requested for customers to ensure the product arrives intact and maintains performance after delivery
We can assist you in selecting the appropriate types of packaging materials to ensure the safety of your product while in transit
We can arrange for warehousing your product and can fulfill and ship your orders upon receipt of a shipping request using the shipping courier of your choice