Many of the novel and next generation products are biologic and represent the cutting edge of biomedical research and have the potential to offer the most effective means to treat a variety of vexing illnesses and conditions that currently have no treatments available. Complex biologic compounds such as cell and gene therapies, recombinant proteins and Monoclonal Antibodies (MAbs) require care and attentiveness throughout the manufacturing process to ensure that their biologic structures maintain integrity, thereby ensuring the desired integrity and potency of the product is maintained. Often times these products can have sensitivity to light, temperature, shear and susceptible to microbial contamination. Therefore, it is necessary to maintain aseptic conditions throughout the production process of these drug products.
AST aseptic filling products address the unique processing requirements to gently care for biologic products during the fill-finish process. Our highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell and GENiSYS systems. We have experience dosing products at temperatures as low as 3°C.
Achieving high yield is absolutely critical with biologic products, because of their extremely high-value. To ensure that every container is properly dosed AST integrates extremely sensitive electronic balances with our system that provide accurate in-process measurement of the volume within the containers. The balances can provide real-time feedback to re-dose low filled containers to minimize any wasted products. The GENiSYS machine is the only tabletop filling system available on the market with this integrated fill weight verification feature.
Pre-filled syringes and combination devices also seem to be a common requirement for biologic products. Many biotechnology companies are gravitating toward silicone free syringe barrel options and desire to eliminate oxygen bubble commonly trapped between the syringe piston and the liquid product. AST has a patented process called multi-stage vacuum piston insertion that is ideal for use with silicone free syringes like West Pharmaceuticals CZ syringes. This process pulls vacuum from within the syringe to remove the oxygen and then gently places the piston into its final location.
AST has the expertise and process know-how to address your fill-finish challenges of your biologic product.