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Clinical Biologic Aseptic Fills

Reliable Fill-Finish Manufacturing of Biologic Clinical Supplies

Manufacture your GMP clinical supplies with confidence when you partner with our team. No matter your modality, be it a protein, peptide, vaccine, or mAbs, our team has the expertise, infrastructure, and resources to fulfill your clinical supply needs. We offer solutions customized to your current progress, whether there are outlined compounding processes and established sterilization procedures, or you seek support developing sterile, scalable processes and formulations.

With diverse and adaptable operations, we efficiently fill your biotherapeutic into any standard vial or syringe using either manual or automated fill-finish systems. Our facilities are carefully designed to ensure compliance with current Good Manufacturing Practices (cGMP) guidelines, prioritizing product safety and sterility. We maintain clean room certification 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. With onsite project management teams, we expedite testing and batch release to seamlessly support your needs through both clinical to commercial campaigns. Trust our continuously expanding capabilities to meet your highest standards.

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Clinical Trial Material Considerations

Clinical Infrastructure

Throughout the clinical phase, it is imperative to maintain stringent regulatory compliance, scalability, and quality assurance requirements. Our dedicated team and specialized equipment are aligned to meet these critical needs. Our aseptic fill-finish manufacturing facilities align with FDA, cGMP, and EU standards for phase I and II clinical trial products. These facilities are monitored, controlled, and recorded 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.

Small Batch Production
During early-stage research, you may face limitations with the accessibility of clinical trial materials. Our ability to produce small batch sizes not only helps conserve your valuable biological product but also saves you time and money. We have a track record of achieving consistently high yields without compromising quality, even when working with limited starting materials.
Batch Records & Engineering Runs
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, 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 that may arise during an active production run.
Bottle & Vial Options

When it comes to clinical trial materials, cost-effective solutions are key to sustaining your program. We provide our clients with access to validated bottles and vials, which deliver substantial cost savings when suitable for your needs. Our validated media fills encompass various ophthalmic bottle sizes including 1cc, 3cc, and 7.5cc, as well as parenteral vial sizes in 2mL, 5mL, 10mL, and 20mL.

Integrated Laboratory Services

As your project approaches pivotal phases, ensure you have the comprehensive support needed to maintain progress. Our experts and operations offer the insight and capacity to provide a customized solution.