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.