Your CDMO Partner for Drug Product Manufacturing
Agile and Flexible Aseptic Filling Solutions
As you consider moving your molecule from drug substance to drug product, selecting the right primary container and fill volume become key components of that decision-making process. Our aseptic filling lines offer flexibility of formats for your liquid drug product and our expert team will partner with you on the best approach to meet your needs.
Our drug product services include the following formats:
- Vials (Range: 2-50R; Standard: 2-10R)
- Pre-filled syringes (Range: 0.5-10 mL; Standard: 1 mL long)
- Cartridges (Range: 1-10 mL; Standard: 3 mL)
Our technologies use ready-to-use nested components in vial, syringe or cartridge format.
Using Aseptic, Isolator Filling Systems with Visual Inspection
Understanding the criticalities of maintaining the integrity, quality and safety of your drug product is crucial when partnering with your CDMO. Our lines utilize aseptic, isolator filling systems with a single-use product and option for both manual and automated visual inspection to ensure the highest quality and safety standards are met:
Segregated lines specific for your biologics and advanced therapies
Gloveless robotic isolators for clinical batches up to 10,000 units per batch.
DP line provides minimal risk to your product, no glass-to-glass contact, and advanced automation.
View video about Drug Product Filling Line for Biologics and Viral Gene Therapy
A line to support your biologics
Gloved robotic isolators for late-phase clinical and commercial batches up to 150,000 units per batch.
DP line includes real-time viable environmental monitoring (EM) with contamination control strategies, no glass-to-glass contact, 100% fully automated inspection, electronic batch records, and pre-use post-sterilization integrity testing (PUPSIT). Line built to fulfill EU GMP Annex 1 standards.
View video about Drug Product Filling Line for Large Scale Biologics
We design formulations to be robust enough to withstand the stressors that occur not only in a filling process, but also those that impact shelf life or final administration routes. If you need other alterations such as dilution or excipient additions, contact us to discuss your specific needs.
Across our entire network we execute accelerated and long-term stability studies on both drug substance and drug product for biologics and advanced therapy products. De-risk regulatory submissions by relying on our proven study design, comprehensive study management and reporting formats.
Robust quality management is at the heart of our manufacturing operations with disposition processes compliant with regulatory jurisdictions. To support you, our network of expert quality and regulatory teams include European Qualified Persons who offer tailored release services.
