Not for every product, full cGMP quality is required. For critical starting material, the “High-Quality” status may be considered sufficient.
HQ: Best of Two Worlds
Biomay has developed a service package based on a quality status we term “High-Quality” (HQ). Our HQ system applies on the one hand the quality management principles and documentation structures of GMP. On the other hand, HQ does not employ production in ISO classified clean room suites, fully validated processes or formally qualified equipment.
HQ manufacturing is therefore more flexible, more cost effective and more straight-forward towards the delivery timeline, as compared to full cGMP.
Prominent examples of HQ-produced products may include DNA templates for mRNA transcription, DNA starting plasmids for viral vector manufacturing or recombinant enzymes for their use in GMP processing.
In the end, the choice of the quality status is always the client’s responsibility. Biomay offers flexible options and can help to provide tailored solutions.