WhiteNest Pharma is excited to announce a pivotal partnership with a leading Contract Development and Manufacturing Organisation (CDMO) that specializes in pharmaceutical Good Manufacturing Practices (GMP) conditions and holds the Manufacturing Importation Authorisation (MIA) for our product category. This strategic alliance is set to significantly advance the development and manufacturing of lyophilised cord blood and adult blood platelets, the critical Active Pharmaceutical Ingredients (API) for our groundbreaking Lysaderm dermatological cream, with potential future applications in dentistry and ophthalmology.
This collaboration represents a vital component of our strategy to navigate the complex regulatory landscape successfully. The CDMO’s expertise and holding of the MIA for our product category are essential in meeting the rigorous quality standards and regulatory requirements for our clinical trials and future commercial distribution.
The partnership is instrumental in securing the operational capabilities necessary for the Clinical Trial Phase, Pre-Marketing, and subsequent stages of Lysaderm’s development. It ensures a steady supply of high-quality products for clinical trials and future commercial distribution, underlining the strategic nature of this collaboration in our long-term development plans.
Our CDMO partner, with its state-of-the-art manufacturing facilities, is uniquely positioned to support the scale-up of autologous and allogeneic therapies. Their extensive experience in developing cell therapy drugs and optimizing processes for the GMP and industrialisation phases adds invaluable depth to our project.
This collaboration is expected to bolster our operational framework, particularly in obtaining the marketing authorization for Lysaderm for the treatment of diabetic foot ulcers. It also sets the stage for resuming the clinical study led by Professor Mariano Sanz, previously interrupted due to regulatory requirements.
WhiteNest Pharma looks forward to the positive impact this partnership will have on our ability to bring innovative treatments to market. We are committed to improving patient care and outcomes through pharmaceutical innovation and this strategic collaboration marks a significant step forward in that journey.