BioCina is a Contract Development Manufacturing Organisation and supplies bulk plasmid DNA in three grades: Research, Highly Documented, and GMP plasmid DNA for pre-clinical to commercial use. All three grades are supplied as non-sterile bulk (DS or API).
Our capabilities include host/plasmid selection from an in-house host library, cell banking and testing.
R&D manufacturing typically consists of a 1-20 L scale fermentation with matching scaled lysis and downstream purification.
GMP plasmid manufacturing follows Good Manufacturing Practices for production and release testing of bulk product for clinical trials through to commercial supply. Our GMP manufacturing fermentation capabilities include 20 and 500 L (wv) Stainless Steel fermenters and a 300 L (wv) single use fermenter. Lysis and downstream processing equipment are scaled to match. All manufacturing processes are defined and controlled to ensure compliance.
BioCina’s intermediate grade of Highly Documented plasmid bridges the gap between R&D and GMP and was designed to provide plasmid for use as a raw material in a GMP process, such as for GMP virus production or toxicology studies.