A Q&A with CEO Dr. Nazende Günday-Türeli
PHOENIX-OITB gGmbH seeks to enable innovative nanopharmaceuticals production according to GMP (Good Manufacturing Practice). It offers a Single Entry Point for a network of facilities, technologies, services and expertise for all the technology transfer aspects from characterisation, testing, verification up to scale-up, GMP-manufacturing and regulatory guidance.
To introduce this new enterprise to potential customers, we sat down with PHOENIX-OITB gGmbH CEO Dr. Nazende Günday-Türeli to discuss the most frequently asked questions.
Dr. Günday-Türeli, tell us a bit about the PHOENIX Single Entry Point.
Nazende Günday-Türeli: PHOENIX offers an “all-in-one” Single Entry Point to users, providing manufacturing, characterization, testing and consulting services to accelerate maturity of nanopharmaceuticals and diagnostic agents. The Single Entry Point offers affordable and easy access to a consolidated network of facilities, technologies, services and expertise for all the development and technology transfer aspects from characterization, testing, verification up to scale-up, GMP compliant manufacturing and regulatory guidance. We are a non-profit organisation headquartered in Germany with service providers across 7 European countries.
Why did you and your co-founders believe such a Single Entry Point was needed?
There is a great amount of scientific research and many patents on medical technology and nanomedicine, globally. But the availability of nanomedicines at the patients’ bedside does not correlate to these numbers. There are several factors contributing to this gap.
The journey that a nanomedicine needs to take until reaching the clinics and eventually the patient’s bedside is a long one, including two main stages. The first is to establish reproducible manufacturing methods and characterization protocols for the small amounts of the prototype version of the nanomedicine in the R&D laboratories that are used for research purposes so that the risk of failure at clinics associated with unreliable and misleading data from R&D phases can be minimized.
Second is the scale-up of these nanomedicines to a pilot scale, mid-to-large amounts, needed to perform late pre-clinical testing of the nanomedicine, as well as to enter into clinics. Here it is very important to maintain a high-quality, GMP compliant production process and product and as well as a sufficient quantity. The smooth and easy transference of the pilot plant production to GMP conditions is a regulatory prerequisite in order to enter to the clinics and reach the market.
In nano-medicine, we have made great progress but it is still very hard to move from one stage to the next, mainly due to problems in repeatability to obtain a high-quality and -quantity product in an R&D environment. It is also due to difficulties achieving GMP-compliant production by design, since it is almost impossible to offer a “one-size-fits-all” scale-up and manufacturing platform for such a broad range of nanomedicines and administration routes.
That’s why we founded PHOENIX: to support our customers to overcome these difficulties enabling transfer of nanopharmaceuticals from lab bench to clinical trials, thus bridging the gap.
What kind of impact can a Single Entry Point have on the nanopharmaceutical field?
End-users can access a wide range of services, including production and characterisation under GMP conditions, as well as quality, efficacy and safety evaluation, through a Single Entry Point. This will help customers bring their product to a GMP environment cost and time efficiently. Most importantly, customers will meet with service providers offering their experience and expertise to guide them along the road to GMP.
Who can benefit the most from PHOENIX?
PHOENIX-OITB gGmbH’s concept and implementation strategy are designed to cover a wide range of nanopharmaceutical manufacturing and characterization methods, formulations and administration routes so that most methods and services of interest are available to the end-user. That means that any end-user seeking help to advance their nanopharmaceuticals towards GMP and clinics can benefit from this broad range of services. We offer a customized set of services to any interested party working in the field.
Where can customers go if they still have questions?
Contact us at info@phoenix-sep.com and we’re happy to advise you!
