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.
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.
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.
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.
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.
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.
The industry is experiencing substantial growth in the need for viral vectors, driven by the demand for viral vectors as a product or reagent. Separately, the current pandemic has significantly increased the need for vector-based vaccines and therapeutics. This growth has resulted in a manufacturing capacity shortage. Tight timelines require new approaches to meet capacity needs. KUBio™ box exists to accelerate access to these therapies and vaccines. Talk to us.