Precise Titration for pH Control: Performing accurate titrations to control the pH of siRNA solutions, ensuring optimal formulation conditions for stability and efficacy
High Yield with Minimal Line Loss: Achieved higher drug product yields while minimizing filling line loss to less than 100 mL, leading to significant cost savings and improved manufacturing efficiency for our clients.
Expertise in High Viscosity and High Concentration Formulations: Proven capabilities in the fill and finish of high viscosity and high concentration siRNA formulations
Aseptic Fill/Finish Line: Equipped with a Bosch isolator system, capable of processing up to 100,000 vials per batch with fill volumes ranging from 0.4 to 35 mL. Meets typical RNA drug filling requirements of 0.5~1.5 mL, with fill weight accuracy within +5%
Proven Track Record: Successfully completed 70 drug product lots with a 100% success rate
Our comprehensive capabilities in both formulation development and the fill/finish process position us as a trusted partner in the development and commercialization of siRNA drug products, delivering high-quality outputs and cost-effective solutions.
You can copy the link and paste it into the browser to watch the whole process of filling production video.
https://www.youtube.com/watch?v=QJvxtjTs8UE
Our isolated vial drug product filling line by BOSCH, is adaptable for GMP aseptic fill & finish for 2 mL/ 6 mL/ 10 mL/ 20 mL/ 25 mL/ 30 mL ISO standard vials, with a maximum capacity of 100,000 vials per batch. The cleanroom grade of this filling line is Grade A, with isolator in a grade C background environment. All materials in direct contact with the products use a single-use system, preventing cross contamination and ensuring product safety.