CAMBRIDGE, England & BRISTOL, Pa.--(BUSINESS WIRE)--Abzena plc, the life sciences group providing services and technologies to enable the design, development and manufacture of biopharmaceutical products, has announced the completion of the facility remodelling for its new antibody-drug conjugate (ADC) GMP manufacturing suite at its Bristol, Pennsylvania site.
The facility is being equipped with state-of-the-art Sartorius and GE equipment for single use scale-up, manufacture and purification processes. The environmentally controlled suite will enable Abzena to produce antibody-drug conjugates (ADCs) for preclinical and early phase clinical studies. The suite is a significant part of Abzena’s integrated ADC capabilities for the design, development and manufacture of ADCs.
The facility and equipment verification and qualification for this ADC GMP manufacturing suite is currently underway, and scheduled for completion around the end of the second quarter of 2018.
Completion of the GMP ADC manufacturing suite construction marks a key point in Abzena’s programme to significantly expand the Group’s integrated ADC chemistry solutions. This ADC manufacturing suite complements the existing GMP manufacturing capability for the scale-up and manufacture of highly potent payload-linker constructs, and the upgrading and expansion of Abzena’s biologics process development and manufacturing capabilities in San Diego. The plans are on track for the initial relocation for Abzena’s biologics manufacturing process and analytical development groups into the new San Diego facility during April 2018.
Abzena has existing client process development programmes scheduled for the Bristol ADC manufacturing facility including an ADC utilising the Group’s proprietary ThioBridge™ conjugation technology and another that has benefitted from an integrated programme comprising cell line development, antibody production and development and manufacture of the ADC product including the linker-payload reagent.
Sanjeevani Ghone, Vice President and Site Head, Abzena, Bristol PA said:
“The completion of this facility is a significant step in realising Abzena’s vision of being a full service and technology provider for the design, development and manufacture of ADCs. Our recent contracts are a testament to our client’s confidence in our expertise and experience in this field.”
Abzena provides proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products.
The term ‘ABZENA Inside’ is used by Abzena to describe products that have been created using its proprietary technologies and are being developed by its partners, and include Composite Human Antibodies™ and ThioBridge™ Antibody Drug Conjugates (ADCs). Abzena has the potential to earn future licence fees, milestone payments and/or royalties on ‘ABZENA Inside’ products.
Abzena offers the following services and technologies across its principal sites in Cambridge (UK), San Diego, California (USA) and Bristol, Pennsylvania (USA):
- Biology research studies, including immunogenicity assessment of candidate biopharmaceutical products and bioassay development;
- Protein engineering to create humanized antibodies and deimmunised therapeutic proteins;
- Cell line development for the manufacture of recombinant proteins and antibodies;
- Contract process development and GMP manufacture of biopharmaceuticals, including monoclonal antibodies and recombinant proteins for preclinical and clinical studies;
- Contract synthetic chemistry and bioconjugation research services, focused on ADCs;
- Proprietary site-specific conjugation technologies and novel payloads for ADC development;
- GMP manufacturer of ADC linkers, payloads & combined linker-payloads; and.
- GMP analytical services for biopharmaceutical manufacturing projects
For more information, please see www.abzena.com