Over the last decade, the development and refinement of gene therapy has led to high demand for the manufacture of this niche drug product that often requires flexibility and ingenuity to successfully execute batch manufacturing. With the founding principle of Symbiosis being to specialise in low volume manufacture we are set up to provide a robust and reliable solution to this increasing demand.
Our team of experts
Having built a team of specialists with gene therapy in mind, Symbiosis has significant expertise in this area. Over the last six years Symbiosis has formed many successful collaborations with clients globally due to a manufacturing capability which demonstrably extends from phase I clinical trial material to commercial manufacture.
Symbiosis has a highly qualified team of process and technical experts, selected because of their wealth of experience and knowledge. Clients find this combined team of focussed, experienced individuals greatly accelerates, simplifies and de-risks the process of moving their products through clinical development to commercial readiness and production.
Furthermore, Symbiosis can qualify bespoke container closure systems and, by working collaboratively with clients, can design filtration and filling rigs that can greatly increase vial yield.
Quality by design
The quality team at Symbiosis is over 30-people strong with project teams formed to focus solely on the client’s gene therapy journey, ensuring all supply chain aspects and documentation is phase appropriate and designed with the clients end goal in mind.
Symbiosis maintains a quality driven culture with compliance being the top priority.
Unlike other CMOs, sterile drug product manufacturing is the core service offering on which the business was founded meaning importance is always placed on investment in compliance with the latest regulatory guidelines. Symbiosis has an internal ‘right first time’ compliance culture.
Timelines driven by you
Understanding clients need for quick access to manufacturing slots and for a degree of flexibility and visibility on timelines means Symbiosis can typically offer clients a three-month lead time to manufacture. This greatly assists the flow of material for both clinical trials and in-market supply allowing clients better visibility for their clinical trial program.
By focussing on gold standard quality compliance, delivering world-class technical expertise and offering operational flexibility, Symbiosis stands out from other CMOs.
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Symbiosis’ viral vector manufacturing capabilities include:
- FDA inspected and MHRA licensed facility
- Drug product manufactured under GMP to meet regulations for clinical trials in US and Europe
- Ability to adopt client processes into GMP cleanroom suites
- Accommodating small fill volumes in line with client requirements
- Process optimisation to ensure vial yield is maximised
- IND and regulatory support for PPQ and commercial batch manufactures
- Dedicated project management and technical expertise