Problem addressed: Ingenza’s SYNBIOMAN platform will address an unmet industry need at the European level for a synthetic biology enabled therapeutic biologics manufacturing capability targeting difficult-to-express proteins and/or hard-to-handle potent protein products that requires novel, efficient, low volume manufacturing. This is a niche high-value market where the customisation and flexibility needed to address such complexity/toxicity means the market is of very limited interest to larger established Contract Development Manufacturing Organisations.
Importance to Society: The SYNBIOMAN platform is highly innovative and will support European competitiveness and growth by developing a unique enabling capability with high growth potential. SYNBIOMAN will meet a distinct and growing market need for specialist Contract Development and Manufacturing Organisations able to safely and cost effectively develop manufacturing processes for hard to handle and/or potent biologics. Ingenza will deliver a unique and proven approach, which now requires demonstration at full GMP level. This enabling platform will create a globally competitive “biofactory of the future” business providing new job opportunities for highly skilled workers. This directly contributes to the expansion of the European biotechnology sector and supports the drive towards developing modern European manufacturing sector based on state-of-the-art ‘omics driven synthetic biology tools and bioprocess technologies.
The SYNBIOMAN production platform will help drug developers make timely decisions on lead compound selection based on ease of manufacturability and accelerated time to clinic. This will be done by delivering a robust, high yielding scalable manufacturing processes able to provide API material for clinical studies and market introduction of new biologics products. This will improve the diversity, availability and speed-to-market of potent drugs addressing unmet clinical needs and biosimilar drugs with reduced cost-of-goods drugs, making treatments more cost effective and providing affordable therapies to a broader patient group in low/middle income counties.
Overall Objectives: The project is supported by five novel biologics developers in the EU and US, two of which will provide the case studies at Phase 2 demonstrating use of both microbial and mammalian cell factories. The Phase 1 project objectives achieved were to:
(i) Define the activities required to achieve Good Manufacturing Practice (GMP) compliance for a highly potent target biologics using mammalian and microbial production systems;
(ii) Demonstrate freedom-to-operate in the areas of interest and defined a proactive IP monitoring strategy reflecting the need to review IP on a customer product-by-product basis;
(iii) Undertaken a detailed market analysis including a review of the rapidly growing biologics market and the high potency active (bio)pharmaceutical ingredients/product niche;
(iv) Assess the size, scale, activities and capabilities of the European and US CDMO markets to optimise the positioning of the innovative SYNBIOMAN platform/offering;
(v) Review the regulatory and infrastructure requirements and develop a strategy to transform the industrial biotechnology tools of Ingenza into a GMP licenced innovative manufacturing facility for high potency active pharmaceutical ingredients;
(vi) Developed a robust business model and test the market appetite for Ingenza’s CDMO offering through direct research and consultation with potential customers.
