Abzena has augmented existing discovery to GMP drug substance and Antibody Drug Conjugates (ADC) manufacturing and associated analytical services with numerous investments in preformulation and formulation capabilities to enable de-risking of CTA/IND candidates.
Abzena’s existing expertise in analytical assessment of biologics and ADCs is strengthened with the addition of miniaturized and high throughput preformulation equipment requiring low material quantities, as well as advanced lyophilization capability. This allows selection of optimal formulation parameters with minimal amount of protein at early stage of Clinical Trial Authorisation/Investigational New Drug application (CTA/IND) candidate selection.
In November, Abzena announced a $20 million investment into two new manufacturing suites. Its antibody Drug Substance manufacturing solution will be built in two new suites housed in the facility recently opened in San Diego (USA). These will contain new Sartorius 500 L and 2000 L single use bioreactors supported by a comprehensive range of scale up and process development equipment.
Dr. Jonathan Goldman, Abzena’s CEO, stated. :
“Sponsors have noted our unique single source high quality integrated solution for biologics API and ADC up to phase 2 scale. They wish to reduce scientific risk from technology transfer whilst maintaining single program management. We have received many requests to initiate formulation development at an early stage in order to further derisk candidate selection. The expansion of capacity, numerous capital investments and adding formulation is part of our strategy to leverage our core competency of integrated early phase biologics discovery and development. We will continue to deliver world-class services from our fully integrated sites in Cambridge UK, San Diego and Philadelphia, USA. We are focused on helping discover, develop and produce drugs at a very high quality whilst minimizing operational risk. Our existing integrated biologics solution is now enhanced, remains best in class for speed and cost, and delivers excellent value to our customers.”
Abzena provides services and technologies for the selection, development, and manufacture of biopharmaceutical products in North America, Europe and internationally. Its technologies include antibody drug conjugate (ADC) linker, antibody humanization, and protein deimmunisation. Abzena as a life science group serves biopharmaceutical companies and academic groups. It was incorporated in 2014 and is headquartered in Cambridge (UK).