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  • Periodic Reporting for period 1 - SYNBIOMAN (Demonstration of a synthetic biology-driven biomanufacturing platform for adaptable cost-effective production of high-value low volume biologics opportunities.)

SYNBIOMAN Report Summary

Project ID: 736304

Periodic Reporting for period 1 - SYNBIOMAN (Demonstration of a synthetic biology-driven biomanufacturing platform for adaptable cost-effective production of high-value low volume biologics opportunities.)

Reporting period: 2016-08-01 to 2016-12-31

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

A detailed independent study of the size and scale of the biopharmaceutical markets in Europe, the US and globally provided details including product types and information on products in development. A competitor analysis looked at Contract Development and Manufacturing Organisations, their markets and individual service offers. This study confirmed the novelty of our Unique Selling Points and Ingenza’s competitive edge.

As part of this study an assessment was made of the regulatory requirements for GMP compliance. A gap analysis of the Quality Management Systems and staffing requirements was made and a strategy designed and implemented to address these gaps and develop a new QMS within the company. Three staff training events were held related to the QMS and the requirements of cGMP. This was led by the EEN coach.

The IP position of Ingenza was reviewed by an independent firm of IP specialists and patent attorneys. The review confirmed Freedom to Operate for the company’s biopharma production offering and provided a proactive IP monitoring strategy.

A review of five potential case studies was made and two case studies were selected for demonstration of the SynBio-enabled GMP biomanufacturing platform in a Phase 2 project.

The company’s business model was revised and updated with information from potential customers and a detailed production costing exercise was undertaken. This included an analysis of Customer production requirements based on the stage of product development (Phase of Clinical Studies or In-market needs).

Ingenza are moving to new facilities in 2017. The infrastructure needs for compliance with GMP licensing requirements have been reviewed. Some redesign of the new Ingenza facility was carried out based on advice from consultants to ensure GMP compliance and remove barriers to licensing.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This Phase 1 project has confirmed that the SYNBIOMAN business opportunity/offering has the potential to drive significant company growth in response to a rapidly growing market demand for innovative Synthetic Biology enabled strain construction coupled to the development of efficient bioprocesses. The market intelligence and the feasibility study provided a strong evidence base for the company to advance to a Phase 2 market replication project designed to remove remaining barriers to the market.Freedom to Operate was confirmed through an independent

Ingenza will deliver and demonstrate a novel synthetic biology (SynBio) driven manufacturing platform that is EMA and FDA certified for GMP production of investigational and commercial biologics. This includes transitioning SynBio tools developed for industrial biotechnology towards addressing issues/opportunities in the growing biopharmaceutical sector (CAGR 9.5%); delivering innovative biomanufacturing capabilities beyond the current state-of-the-art. To achieve this goal Ingenza will deploy its inABLE® suite of proprietary SynBio tools including those for high throughput gene cloning, efficient strain screening/construction and effective bioprocess development - all integrated with state of the art single use biofermentors and downstream process technologies. Phase 2 will move Ingenza’s biomanufacturing process, currently at TRL 6 to TRL 9.

Ingenza expect to reach the market in 2019 with the SYNBIOMAN platform offering the cost effective manufacture of potent and difficult to handle biologics. The predicted sales revenues should achieve an excellent return on investment (ROI) after 5 years. The predicted company development and growth will create an additional 13 high skilled jobs in scientific research, biomanufacturing; regulatory compliance and quality assurance within 1 year of project completion and cafter 5 years 60 jobs will have been cereated. In addition, a business development executive with experience of the biologics pharmaceutical sector in Europe and North America will be recruited during Phase 2 to drive new sales and expand the product development pipeline beyond the five current customers and early stage expressions of interest.

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