End-to-End Integrated Solutions for Robust, Scalable and Reproducible Gene Therapy Manufacturing

 

Speed to market is essential for gene therapies. When accelerating the journey to clinical production, robust process development, de-risked scale-up, and efficient project management are needed to quickly enable a cost-effective manufacturing process.

An integrated solution utilizes engineering expertise to combine multiple unit operations into a single, centrally-automated process, supported by comprehensive technical services. This philosophy can be applied to two or more-unit operations or be expanded to provide a complete end-to-end solution.

Moving to integrated solutions will help simplify and streamline your manufacturing process, speeding time to market and reducing overall cost of goods. The simplified process, using standard, equipment, qualified single-use system designs and components, lowers the risk for operator error, which helps assure compliance with cGMP and assure product quality.

 

 

 

Click on each image to discover each standard manufacturing platform:

 

Are you designing a new process or planning a new facility? Create Your Virtual Facility by requesting a guest account to our AcceleratorSM Vision Platform.

 

e-Book

Insights On Successful Gene Therapy Manufacturing and Commercialization

 

Inspired by recent FDA gene therapy approvals, technological advances and successful results, the Cell Culture Dish have partnered with industry experts Pall Biotech, Cobra Biologics, SCIEX, REGENXBIO Inc., BioTechLogic and Jane Barlow & Associates, LLC to share their perspectives in a new ebook, 'Insights on Successful Gene Therapy Manufacturing and Commercialization'...

Article

Accelerate Gene Therapy's Time To Market With Integrated Solutions

 

Gene therapies can have a significant impact on patients – in many cases, treating previously intractable conditions. Developers are keen to accelerate time to market, but engineering expertise is required to overcome manufacturing sticking points. Pall offers integrated solutions that bring together various processes into a single, coordinated, and controlled environment. This approach should enable the medicines of the future to reach patients faster by trimming the excess off manufacturing protocols...

Regulatory Support and Quality by Design of Single-Use Technologies to Accelerate Your Time to Market

 

Chemistry Manufacturing and Controls (CMC) for gene therapies is currently one of the biggest hurdles for regulatory approval and presents a significant risk to the success of new gene therapy drug candidates. In this white paper Quality by Design (QbD) of Adeno-Associated Virus, we discuss the identification of Critical Quality Attributes (CQAs) surrounding the manufacture of adeno-associated virus, and how to ensure these attributes are met through a defined set of Critical Process Parameters (CPPs) across both upstream and downstream unit operations.

 

Blog Post

How To Achieve Regulatory Approval for Viral Vectors

At any point in time during the process of developing and commercializing a new drug, failure or setbacks can cause significant delays at best, or cancellation of the project at worst. In 2020, no less than 14 gene therapy submissions or study requests have been delayed or openly rejected by regulators due to a lack of CMC documentation.

 

 

 

The Allegro™ single-use platform provides a comprehensive range of disposable process solutions from upstream, through downstream to formulation and filling.

We have developed a unique approach, keeping the same materials of construction to allow easy scale-up from lab scale to full cGMP commercial operation, with the capability to provide the same robustness, reliability and batch records that you require to produce your gene therapy.

We can serve our customers globally with strong technical support and a very robust and reliable supply chain with our global manufacturing platform meeting all the necessary quality requirements.

We pride ourselves on the strong quality by design and ease-of-use attributes that we put into all our Allegro Single-Use Systems, thus allowing our end users to meet consistently all the appropriate safety and regulatory requirements.  

 

 

 

The AcceleratorSM Documentation Center is a high-quality and comprehensive product documentation center that helps our customers manage the vast amount of documentation required for regulatory submission.

This portal collates all current documentation to help you navigate compliance quickly and efficiently. The electronic regulatory dossiers help you in your ongoing risk assessments by alleviating the pressures of preparing documentation for regulatory compliance and audits.

Visit the portal

Article

Maximizing Speed to Market - Flexibility Benefits of Single-Use Technology for Gene Therapy Manufacture

 

Gene therapy usually addresses small patient populations, so batch sizes tend to be small and relatively few in number. This is a ‘sweet spot’ for single-use technology. In addition, the population the gene therapy segment is addressing is usually lacking any type of medication, which makes speed to market particularly important. Single-use technology allows you to plan and build facilities relatively quickly...

Webinar

Pathways To Success - Expert Insights On Single-Use Technology

 

The accelerated expansion of manufacturing facilities needed for COVID-19 vaccines has driven the implementation of single-use technology (SUT) across many sites worldwide. How new systems get implemented varies, and each supplier has a different approach to supporting end-users...

Innovative Training Solutions to Fill the Workforce Gap for Gene Therapies

 

The increasing adoption of single-use technologies and specialized production processes requires efficient operator training.

 

We offer various training solutions from:

  • Train The Trainer Sessions: a compact training program focusing on specific content and how to teach it to your teams
  • On-site Training Solutions: high-quality scientific consulting services that deliver insights for bioprocess efficiency

 

 

 

Visit the Accelerator E-training Center, our digital learning platform developed to improve operator efficiency. This platform has over 200 instructional videos which cover Pall technologies and key process steps as well as knowledge checks to evaluate knowledge retention and operational readiness.

 

Content is available in six languages.

 

Specific gene therapy-focused training programs featuring Pall technologies can also be obtained from these collaborating training centers:

 

These centers offer both virtual and face-to-face training, including practical hands-on sessions on state-of-the-art equipment to cover the full gene therapy production process.