Proven Aseptic Fill-Finish Manufacturing of Clinical Supplies
Manufacture your clinical supplies with confidence when you partner with our team. Whether your formulation is developed with established compounding processes and established sterilization procedures, or you seek support developing sterile, scalable processes and formulations, we offer customized solutions tailored to your needs.
With diverse and adaptable operations, we efficiently fill your therapeutic into any standard vial or syringe using manual or automated fill-finish manufacturing systems. We carefully designed our facilities to ensure compliance with current Good Manufacturing Practices (cGMP) guidelines, prioritizing your product’s safety and sterility. We maintain cleanroom certifications and have a successful track record of media fills.
All filled materials undergo rigorous release testing and examination by our dedicated QC and QA teams before shipment to clinical sites, ensuring that it meets your highest standards. With onsite project management teams, we expedite testing and batch release to seamlessly support your needs through clinical to commercial campaigns. We also continuously expand our capabilities to serve you well with both current and future projects.
Clinical Manufacturing Considerations
Throughout the clinical phase, it is imperative that you maintain stringent regulatory compliance, scalability, and quality assurance requirements. Our aseptic fill-finish manufacturing facilities align with FDA, cGMP, and EU standards for Phase I and II clinical trial products and are monitored, controlled, and recorded for environmental monitoring in real-time. To maintain a clean and controlled environment, we use our dedicated Water for Injection (WFI) system and HVAC system equipped with 99.99% efficient HEPA (High-Efficiency Particulate Air) filters. Our facilities’ HVAC systems are strategically located in an easily serviced mezzanine, minimizing the risk of weather-related malfunctions.
During early-stage research you might encounter challenges with clinical trial media accessibility. Our ability to produce small batch sizes helps conserve your active pharmaceutical ingredient (API) to save you time and money. We have a history of achieving consistently high yields without compromising quality, even with limited starting materials.
Creating a comprehensive batch record is critical to meet regulatory requirements and ensure you have a successful clinical phase. Our batch records outline and document every step involved in manufacturing your product for clinical use, which is crucial for the Chemistry, Manufacturing and Control (CMC) section of an Investigational New Drug (IND) Application. We also execute smaller scale engineering runs to proactively address any potential challenges during an active production run.
Cost-effective solutions for your clinical trial materials are key to sustaining your program. We offer you access to validated bottles and vials that deliver substantial cost savings when suitable for your needs. Our validated media fills span a variety of bottle sizes, including 1cc, 3cc, and 7.5cc, as well as parenteral vial sizes in 2mL, 5mL, 10mL, and 20mL.
Diverse Molecular Support
Small Molecules
Optimize your formulation and manufacturing processes to prepare for early phase clinical studies with our comprehensive support.
Nucleic Acids
Overcome complexity as you prepare your nucleic acid therapeutic for scale-up production with our services. We ensure your product’s purity and quality while effectively managing costs.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.