PHOENIX-OITB gGmbH is a non-profit organisation headquartered in Germany with partners across 7 European countries.
As a Single Entry Point, PHOENIX SEP offers a top-tier and consolidated network of facilities, technologies, services and expertise to bridge and facilitate the path of nanopharmaceuticals from bench to bedside.
What makes nanopharmaceuticals different to other medicines? The nano size alters physical, chemical and/or biological characteristics that differentiate the in vivo behaviour as compared to conventional counterparts, often improving their efficacy.
The journey nanopharmaceuticals need to take to reach the market and eventually the patient’s bedside is long and includes two main stages that the production process and the product need to target:
The scale-up from the small amount of the nanopharmaceutical produced in the R&D laboratories that are used for research purposes to a pilot plant of mid-to-large amounts, needed to perform pre-clinical evaluation and testing of the nano-medicine, as well as to enter into clinics.
At this stage, it is vital that the quality of the production process and the product itself are very high and that adequate quantities are produced to enter each stage.
The smooth and seamless transfer of production methods to GMP environment to ensure quality, efficacy, and safety of the nanopharmaceuticals that are to be clinically approved.
Despite the efforts during the last years in the field of nanopharmaceuticals, there are still difficulties moving from one stage to the next, mainly due to problems in repeatability to obtain a high-quality and -quantity product for entering GMP environment and due to difficulties of achieving industrial-scale production.
Consequently, there are still barriers to be overcome that hinder nanopharmaceuticals to reach the market.
PHOENIX supports its customers to overcome these difficulties, enabling transfer of nanopharmaceuticals from lab bench to clinical trials. PHOENIX provides a Single Entry Point (SEP) for a network of facilities, technologies, services and expertise for all the R&D/I and technology transfer aspects from characterization, testing, verification up to scale-up, GMP manufacturing and regulatory guidance in a timely and cost-friendly manner.
PHOENIX SEP will enable the seamless, timely and cost-friendly transfer of nanopharmaceuticals from lab bench to clinical trials for more effective and faster market entry.
PHOENIX SEP 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 technology transfer aspects from characterization, testing, verification up to scale-up, GMP compliant manufacturing and regulatory guidance.
Contact us and we will put you in touch with a dedicated contact person who will learn more about your specific needs.
Together, you can choose your desired services and design a plan.
