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• The gene therapy field is poised to deliver an increasingly broad and impactful set of treatments across many different diseases.
• A linchpin for success is a robust, cost-efficient, and scalable viral vector manufacturing workflow.
• Standardized production methods and fit-for-purpose workflow technologies are now available to address the unique development and manufacturing needs of viral vectors.
• Access to the necessary capacity and expertise along with strategies for a simplified pathway to GMP manufacturing, a shorter process development timeline, and a reduction in the exorbitant fixed costs associated with facility development are also available to help realize the true potential of gene therapy manufacturing space.

• Implementation of PAT into your bioprocesses ensures quality in biopharmaceutical manufacturing through real-time monitoring and control
• Analytical methods of monitoring and control of identified critical process parameters and critical quality attributes allows PAT to ensure quality of bioprocesses

With a process monitoring tunnel you can monitor 100s of CPPs in a single graphical interface that captures the overall health – both past and present – of your bioprocess and reliably predicts its future health.

• While gene therapies can offer remarkable outcomes for patients, realizing their full potential requires an efficient workflow for viral vector production.
• Faced with limited process development and manufacturing expertise, gene therapy innovators can partner with integrated solution providers to fill these gaps and ensure a robust, optimized, and scalable viral vector production process.
• An integrated solution provider offers significant advantages in contrast to an assemblage of multiple suppliers focused on individual workflow steps which may lack a holistic view of operations.

Take a few minutes and navigate through our mAb, ADC, mRNA, Vaccine, and Cell and Gene Therapy process templates. Go ahead and dive into each unit operation to uncover the best option for your process.

• Viral vectors are the most reliable and sought-after method for gene delivery.
• Use of adherent cell culture for manufacturing these vectors, however, can lead to limited cell growth, lower productivity, and necessitate use of animal-derived media supplements which increase the risk of introducing adventitious agents.
• The VirusExpress® 293 AAV production platform reduces risk and accelerates timelines with use of chemically defined animal component-free cell culture media that has been optimized for viral vector manufacturing.

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This whitepaper provides an overview of the technology transfer process and describes the development and optimization of a platform to manufacture a vaccine for tropical diseases.

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