Accelerate commercialization of your product by leveraging our expert manufacturing facilities and capabilities. Our trained personnel, proven processes, certifications, and world-class quality control standards are already in place for manufacturing your product. Using our team and facilities will decrease your start-up costs and allow you to focus on product development and growing your company.
• 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.
In-process and Release Testing
Genemed can test your product at every step during the manufacturing process as well as at the time to release the final product. In process testing is performed on products during the manufacturing process to ensure it is being manufactured to specification. Final inspection and performance testing is performed by QC personnel on finished goods prior to being released for sale.
• 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, Labeling, Kit Assembly, Packaging, and Shipping
Genemed can fill, label and package your product. Filling is conducted in an ISO Class7 7 Modular Enclosure. We have two automated filling and capping machines equipped to fill 0.5 ml or 2 ml tubes with screw caps.
• Various filling methods are utilized at Genemed to meet your product needs
• Automated filling and capping occurs in Cleanroom suites
o We can fill up to 45,000 vials per day
o We can fill from 100 l to 2 ml per vial
o Another machine has an output of 30,000 vials per day, and also has labeling capabilities
• Manual filling is performed with micropipettes, repeaters and peristaltic pumps and is performed in Laminar flow hoods
o Manual filling can be performed for any volume from the microliter range to several liters
Label design, label printing, and label application are all performed by trained personnel. There are two labeling rooms where filled and capped vials are labeled.
• 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
• Campaign-style manufacturing with pre-and post- cleaning as well as line clearance between batches eliminates the chance of mislabeling of tubes.
Genemed can assist you with your kit configuration, label, and packaging design to conform to your branding strategy. Our kit packaging procedures ensure identity and traceability of the kit as well as each of its components. Our inventory control system ensures that the appropriate amount of each component is used during each kit packing operation.
Genemed has performed various shipping validation for different product types.
• 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