🧪 This facility is designed for process development, pilot scale, and clinical supply. It meets GMP standards and offers flexibility with interchangeable modules.
🔄 The system can handle 500 to 50,000 units per batch, ensuring cost efficiency and reduced product loss, catering to rare disease and gene therapy projects.
Introduction:
The article discusses Recipharm’s launch of a new modular sterile filling system at its Wasserburg, Germany facility. This system is designed to enhance aseptic filling capabilities for process development, pilot scale, and clinical supply of pharmaceutical products. It aims to address the growing demand for flexibility and efficiency in drug development, particularly for specialized treatments such as rare diseases.
- Recipharm has introduced a modular sterile filling system that complies with GMP standards and operates within a Grade A isolator.
- The system is adaptable, supporting various product types such as vials and syringes, with plans to add a pre-filled syringe (PFS) module.
- It can handle batch sizes ranging from 500 to 50,000 units, facilitating all development phases of pharmaceutical products.
- The system is optimized for small-batch production, catering to clinical development projects in specialized fields such as cell and gene therapies.
- This installation is part of Recipharm’s broader commitment to innovative technologies, enhancing efficiency and cost-effectiveness in pharmaceutical development.
Conclusion:
Recipharm’s new aseptic filling system represents a significant advancement in pharmaceutical manufacturing, providing a versatile and efficient solution for clinical production needs. By focusing on small-batch production capabilities, the company aligns its services with the increasing requirements of specialized therapies, ultimately supporting faster and more effective drug development processes.
