Formulation, final filtration, and filling are the last steps in viral vector production. A rational formulation design developed by optimizing solution conditions and high-quality excipients can significantly increase viral vector stability and shelf-life. Our wide range of high-quality buffers, salts and stabilizers, low in bioburden and endotoxins, are specifically developed for high-risk applications and can ensure successful downstream processing and formulation of your final gene therapy product.
Designing a successful single-use sterile filtration system should focus on maximizing the recovery of these high-value therapies and consider different filter options, process requirements, sampling needs, and if pre-use post-sterilization integrity testing (PUPSIT) will be performed.
Our Mobius® single-use assemblies offer you flexibility and our specialists can help you design a custom assembly from our broad portfolio of filters and single-use components. These systems are scalable and can be easily replicated to meet your evolving needs.
Supported by our Emprove® program, our excipients, filters and single-use components have extensive documentation, minimizing regulatory and quality-associated risks in your manufacturing. All this simplifies the complexity of your supplier qualification and speeds up processes, thus reducing the total cost of ownership.
Download our Emprove® Program brochure to learn more about how to improve your regulatory processes.
This white paper explains the challenges and keys to success in pharmaceutical manufacturing processes and raw material supply chains when it comes to sourcing raw materials in a continually evolving regulatory environment.
Confidently speed your way through the regulatory maze and fast track your new drug to market.
Enabling a more robust risk assessment.
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