UPDATES

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.

WhiteNest Pharma announces an upcoming MDR inspection by KIWA Cermet for the BioNest 12D, BioNest 2.0, and BioNest Transfer systems on March 13-14. This pivotal review is expected to secure a new certification for these innovative systems, reinforcing our commitment to quality and safety in medical devices.

WhiteNest Pharma is excited to announce the completion of the planning phase for an innovative pharmaceutical plant dedicated to manufacturing lyophilized cord blood and adult blood platelets. This significant milestone paves the way for the production of high-value pharmaceutical applications, including the notable dermatological cream, Lysaderm.

The facility, designed to span a substantial area, is set to become a cornerstone of pharmaceutical innovation. It will house a specialized pharmaceutical department for the production of lyophilized umbilical cord blood products, with a future phase aimed at creating ophthalmic solutions. An additional section will focus on the production of anticoagulants for blood bags, ensuring a comprehensive approach to meeting healthcare needs.

The project’s completion was achieved through meticulous planning and detailed analysis. This effort has resulted in the creation of architectural layouts that prioritize isolated production areas with dedicated access for materials and personnel, enhanced by a dedicated HVAC system to ensure optimal environmental control.

Key deliverables from this phase include a comprehensive User Requirement Specification that outlines the project’s scope, including architectural and environmental classification layouts, material and personnel flow designs, and a list of process equipment with potential suppliers. Specifications for construction materials and a detailed budget estimate have also been prepared, ensuring clarity and precision in the project’s next steps.

Looking ahead, WhiteNest Pharma has outlined a GMP Readiness Plan, detailing the steps required for authorization by regulatory authorities, including AIFA. This plan marks significant milestones toward the product’s registration process, indicating a clear path forward for the plant’s construction and operational phases.

The completion of this project phase is a testament to WhiteNest Pharma’s commitment to advancing medical treatment through innovation and quality manufacturing practices. As we move forward, this facility is poised to enhance our manufacturing capabilities significantly and contribute to the broader pharmaceutical industry.

WhiteNest Pharma is proud to announce a strategic collaboration with a prestigious university’s Pharmacological Sciences Department to enhance the formulation of Lysaderm, aiming at scalability for global markets while upholding the highest quality standards. This partnership signifies our dedication to pioneering a solution that meets the growing demand for effective dermatological treatments.

The focus of this joint research effort is to develop a formulation that ensures optimal delivery and effectiveness of Lysaderm’s active components. The study will explore innovative approaches to solubilizing and hydrating the product’s base, leveraging advanced polymeric solutions. This endeavor is expected to refine the product’s characteristics, including hydration speed and stability, ensuring it meets stringent quality and efficacy criteria.

This collaboration underscores WhiteNest Pharma’s commitment to integrating scientific research with practical applications, driving forward our mission to bring advanced therapeutic options to the healthcare market. We are enthusiastic about the potential breakthroughs this partnership will foster, contributing significantly to the field of regenerative medicine.

WhiteNest Pharma looks forward to sharing the outcomes of this research, confident in its potential to enhance patient outcomes and establish new benchmarks in treatment efficacy.

A recent study published in Blood Transfusion (2023; doi: 10.2450/BloodTransfus.492) details the successful validation of WhiteNest Pharma’s BioNest 2.0 system in a multi-component cord blood banking exercise. This international study, involving 12 public cord blood banks from Spain, Italy, Greece, the UK, and Singapore, signifies a pivotal development in the field of regenerative medicine.

The research aimed to establish a standardized process for creating cord blood platelet concentrate (CB-PC), platelet-poor plasma (CB-PPP), and leukoreduced red blood cells (CB-LR-RBC) utilizing the BioNest 2.0 system. With over 80% of umbilical cord blood units traditionally discarded due to low stem cell counts, this validation marks a critical advancement towards reducing waste and expanding the use of cord blood in clinical settings.

The study’s protocol involved a double centrifugation process to extract CB-PC, CB-PPP, and CB-RBC, with further treatments like leukoreduction and gamma irradiation. Results demonstrated a 99% compliance for volume and an 86.1% compliance for platelet count in CB-PC, among other successes, illustrating the BioNest 2.0 system’s capability to meet stringent quality standards.

The implications of this validation extend beyond cord blood banking, opening new avenues for the use of cord blood components in treatments for wound healing, corneal ulcers, and neonatal transfusions. WhiteNest Pharma is dedicated to furthering research and development in this area, enhancing the economic and clinical value of cord blood banking globally.

The BioNest 2.0 system’s validation as reported in Blood Transfusion reinforces WhiteNest Pharma’s commitment to innovation in healthcare. By improving the efficiency and application of cord blood banking, we take a significant step towards maximizing the therapeutic potential of cord blood components.

WhiteNest Pharma announces a pivotal moment in the quest for innovative periodontal treatments. Our latest project, focused on the use of lyophilized umbilical cord blood platelet lysate for periodontal regeneration, has been meticulously developed and is now poised for the final stage of regulatory approval from the Spanish Agency for Medicines and Health Products (AEMPS).

Under the expert guidance of Principal Investigator Mariano Sanz Alonso, alongside a distinguished team of researchers, this Phase 1 trial titled “The Use of Lyophilized Umbilical Cord Blood Platelet Lysate in Periodontal Regeneration of Intraosseous Defects: An Open-Label Proof of Principle Study,” has successfully navigated the initial phases of approval. With a protocol rigorously reviewed and endorsed by the Complutense University of Madrid’s ethics committee, our study is set to explore an uncharted territory in dental medicine. The commitment of ten participants will soon bring new insights into periodontal therapy, marking a significant stride towards addressing periodontitis with groundbreaking regenerative techniques.

The forthcoming approval from AEMPS is more than a procedural step; it represents the culmination of collaborative efforts and rigorous planning. This milestone will not only enable the commencement of this trailblazing study but also solidify WhiteNest Pharma’s role at the forefront of regenerative medicine research. Our focus remains on delivering innovative solutions that promise to enhance patient care and treatment outcomes in periodontal disease.

WhiteNest Pharma remains steadfast in our mission to pioneer advances in healthcare. As we await the final nod from AEMPS, our team is prepared to embark on this exciting phase of clinical research, hopeful for the potential benefits it will bring to individuals suffering from periodontal conditions. We are committed to transparency and will continue to provide updates on this important journey.

WhiteNest Pharma announces a pivotal advancement for non-transfusional blood components in Italy, following the Centro Nazionale Sangue’s (CNS) recent clarification on national tariffs, as detailed in their FAQ section. This update directly impacts the use of adult blood allogenic platelets processed with the BioNest 12D system, addressing prior uncertainties in ‘L’Accordo Stato Regioni ASR 90/CRS del 17 June 2021’.

Previously, varied interpretations of the agreement had led to a decrease in requests for non-transfusional use of adult blood allogenic platelets in certain regions, affecting BioNest 12D’s market presence. The CNS publication now clarifies tariff applications for these components, ensuring uniform understanding and reinstating the system’s utilization. Key to this update is the allocation of tariffs per aliquot derived from a parent product, simplifying the cost structure for medical facilities and promoting broader access to these essential treatments.

This clarification is expected to revitalize BioNest 12D’s role in Italian healthcare, facilitating enhanced patient care through the widespread availability of non-transfusional blood components. WhiteNest Pharma looks forward to supporting healthcare providers with this clarified framework, aiming to improve therapeutic outcomes across the region.

The CNS’s initiative in providing clear guidelines marks a significant step forward in the efficient use of blood components for non-transfusional purposes. WhiteNest Pharma is committed to aligning with these directives to ensure the BioNest 12D system continues to contribute to innovative medical treatments in Italy.

WhiteNest Pharma has achieved a significant milestone by entering into an agreement that promises to significantly propel its pharmaceutical project forward. This strategic move underscores our commitment to innovation in the development of lyophilized cord blood and adult blood platelets, pivotal for a range of pharmaceutical applications including the novel dermatological cream, Lysaderm.

In collaboration with a leading pharma player, WhiteNest Pharma is set to enhance its research and development capabilities, reinforcing our mission to deliver cutting-edge medical solutions. This partnership reflects our dedication to leveraging the latest advancements in pharmaceutical technology to meet the growing demands of healthcare providers and patients alike.

This agreement enables WhiteNest Pharma to further our contributions to the pharmaceutical industry by focusing on the manufacture of high-quality, innovative products. It serves as a foundation for future advancements in regenerative medicine and other therapeutic areas, offering new hope for treatments that are more effective and accessible.

The collaboration is a strategic alignment with our vision to be at the forefront of pharmaceutical innovation, emphasizing our commitment to improving patient outcomes through science and innovation. It also highlights our proactive approach to navigating the complexities of the pharmaceutical landscape, ensuring that we remain adaptive and responsive to the needs of the market.

WhiteNest Pharma is excited about the prospects this agreement brings to our stakeholders and the broader healthcare community. It marks a pivotal moment in our journey towards becoming a leader in pharmaceutical innovation, setting new standards for excellence and efficacy in the industry.

We are committed to providing updates on the progress of this collaboration and its contributions to our product offerings and capabilities. WhiteNest Pharma looks forward to the positive impact this agreement will have on our ability to serve the healthcare community and enhance patient care globally.