Introduction
In contemporary drug development, high-concentration formulations, defined by antibody concentrations surpassing 100mg/ml, stand as pivotal solutions, particularly in subcutaneous injections. With nearly 80% of FDA-approved monoclonal antibody products falling into this category, the demand for high-concentration formulations are burgeoning within the biological industry.
Advantages and Challenges
Advantages
High-concentration formulations offer conspicuous advantages, notably in subcutaneous injections where volume constraints necessitate concentrated solutions to deliver therapeutic doses effectively.
Challenges
However, alongside these advantages come inherent challenges. These include heightened viscosity, volume exclusion issues, the Donnan effect, and complexities in system hardware design.
Addressing Challenges with Cobetter’s Solutions
Cobetter’s innovative structural designs in conventional screen ultrafiltration TFF cassettes present significant breakthroughs in overcoming these challenges, especially in the production of high-concentration formulations.
Case Studies
Case 1: Lab-scale Monoclonal Antibody Product
Initial Solution Concentration: 18g/L
Inlet Flow Rate: 550ml/min
Despite viscosity increases, meticulous pressure adjustments and buffer flushing ensured a remarkable 98% sample recovery.
Case 2: Lab-scale Monoclonal Antibody Product
Initial Solution Concentration: 21g/L
Inlet Flow Rate: 55ml/min
With adept pressure management, the desired concentration factor was achieved with 95% sample recovery. Efficient cleaning with 0.1M NaOH further streamlined the process.
Case 3: Pilot-scale Monoclonal Antibody Product
Initial Solution Concentration: 14g/L
Inlet Flow Rate: 699ml/min
Despite scale-up challenges, a commendable 93% sample recovery was attained through meticulous buffer flushing and cleaning with 0.1M NaOH, ensuring optimal flux recovery.
Conclusion
In the dynamic landscape of pharmaceuticals, Cobetter remains steadfast in its commitment to innovation, continuously enhancing products to deliver high-quality solutions that not only reduce costs but also enhance safety and efficiency in drug production.
Contact Us
For further inquiries regarding our products or to discuss specific experimental requirements, please reach out to sales@copure.com.au
