Newsletter | September 16, 2020

09.16.20 -- Deliberations/Considerations/Pathways To Achieve Viral Preparedness

Never Too Early To Plan For Automation

Your automation strategy can be designed to expand with your business if you consider your choices in the initial stages. Early platform design selections can greatly affect your future flexibility and ability to show compliance throughout regulatory reviews.

The Insource vs. Outsource Dilemma

Prior to making critical capacity decisions, a small biotech company completed an economic evaluation of manufacturing options to ensure it was selecting the best fit for its drug development needs. Discover the critical elements of this analysis that may help to balance your assessment.

Three Options To Viral Vector Manufacturing Capacity

Thought leaders working in the viral vector manufacturing space recently participated in a virtual think tank (VTT), a unique platform that brings together leading minds to discuss viral vector manufacturing facility design. This discussion included the current challenges and trends influencing design considerations for viral vector manufacturing facilities and how they can impact companies developing cell and gene therapies.

Tips For Viral Vector Production

The viral vector market continues to grow, and the increased interest in improvements in manufacturing technologies is driven by recent approvals in cell and gene therapies. These scalable and cost-efficient processes for GMP manufacturing environments address viral vector manufacturing challenges.

Developing A New Biologic Drug: Regulatory Challenges And Considerations

The journey from research lab to market is a long one, and most drug candidates may not make it. Along the development journey there are many regulatory milestones and hurdles. Here are some tips to assist with up-front planning to alleviate headaches down the road.

Is Not Using A CDMO Slowing Down Your Process Development?

Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

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