INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• Leveraging Innovative Technologies, Best Practices And Strategies To Accelerate Biologics Development And Commercialization

  Gain insight into how practical implementation of innovative technologies and solutions such as multi-attribute method, modernized cell line development workflow using high-yield cell lines and automated systems, as well as next generation purification resins help to accelerate biologics development and commercialization.

• Multiplexing: Managing Risk With Proven, Single-Use Solutions

  Typically, demand forecasts for drugs prior to launch reflect a huge range of expectations. This illustrates just how hard it is to forecast accurately. Instead of trying to make better predictions (which will never be wholly accurate nor truly able to remove risk), or erring on the side of overcapacity (which is a drag on ROC), developers and CDMOs should seek manufacturing flexibility.

• Understanding The CMC Regulatory Landscape For Cell And Gene Therapy Products

  The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

• ÄKTA Pilot 600 Chromatography System

  ÄKTA™ pilot 600 is a bench-top chromatography system well-suited for both GMP and non-GMP work. The wide flow and pressure range allows both production of technical batches and scale-up studies as well as small-scale production of GMP-grade material.

• Overcoming Scalability Challenges With Autologous Therapies

  Autologous immunotherapies have evolved in recent years to bring breakthrough treatments to the market. However, the complexity of the production process often results in extended timelines and high manufacturing costs, limiting the scalability and application across therapeutic indications. In this webinar, Catalent presents a clinical-to-commercial perspective on autologous therapies.

• Your Gene Therapy Partner From Discovery To Commercialization

  The MilliporeSigma organization is dedicated to supporting your cell and gene therapy from early phase through product release.  Not only does our BioReliance® Services organization have over 25 years of experience in manufacturing viral vectors, we can also leverage the innovative products and services within the wider organization to support your therapy. This video will highlight three ways you can partner with us to optimize the productivity of your cell line. For those beyond the discovery phase, this video will highlight how our Process Development group helps ensure success from clinic to commercialization.

• Considerations For Your First Clinical Trial

  For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming. Tt is important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. This paper reviews seven ‘clinical trial supply best practices’ to help ensure a successful trial.

• Addressing The Complexity Of Process Validation For Cell And Gene Therapy Products

  The expectation — just as it is with biologics — is that the process is the product. However, cell and gene therapy products have unique features that must be considered during process validation.

• Collaborative Relationship Allows Avectas To Accelerate The Translation Of SOLUPORE™ Into The Clinic

  Avectas, a cell engineering company, was preparing its non-viral cell engineering solution technology for commercialization and required its platform to be assessed by an experienced third party. They requested support from CCRM, a Canadian centre of excellence in cell and gene therapy and a reliable partner to extend their development capacity and capabilities.

• How We Help: Getting Started With Premier FSP

  We have created a flexible sourcing approach that gives operational teams the benefit of our clinical research expertise and access to our extensive resources. Our functional service provider (FSP) model lets you control and fine-tune your level of involvement so you have full flexibility in deciding how hands-on (or hands-off) you want to be.