Search results for " market"
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Flexible Facilities for Viral Vector Manufacturing
“Speed to market is critical for most, if not all, biologics. This is quite relevant in the gene therapy segment as many gene therapies are qualifying for orphan drug status or fast track designation …
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Getting Ahead of the Game in Cell and Gene Therapy
Successes in the clinic have placed many cell and gene therapies on an accelerated route to market. But unless developers consider, at an early stage, how they might produce their product at scale, th…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
Personalized medicines
Having a model-based approach is especially useful for personalized medicines, which typically target niche disease markets and small patient populations, but for which eac…
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Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
Though monoclonal antibodies are expected to continue dominating the market, a more diversified pipeline that includes, for example, DNA and RNA molecules and cell and gene therapies, is anticipated a…
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Best Practices for Selecting a Top-Quality Cell Line
As a result, the process of preparing them so they are safe and effective is multifaceted and complicated, according to Kris Simonyi, global marketing manager with Bio-Rad Laboratories. “One must conf…
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Methods Accelerate Biosimilar Analysis
…arifying regulatory requirements and expectations for demonstration of biosimilarity in support of a marketing application (1).
As the foundation in the development of biosimilars is the analy…
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Tips for Viral Vector Production
The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. In this blog article, insights are shared around the cha…
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Monitoring and Control of Inline Dilution Processes
Large tank farms in biomanufacturing plants occupy expensive real estate that can be put to more productive use in today’s drive to intensify the production environment, agrees Gerard Gach, chief mark…
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Tools and Processes for Mature and Emerging Therapies
Emerging therapies
As biologic drugs mature and biosimilars move to market, bioprocessing technologies are expected build on current technologies to improve efficiencies. For emerging therap…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
By Feliza Mirasol
With the recent FDA approvals and commercialization of cell and gene therapies in the US market and a pipeline of cell and gene therapies progressing toward regulatory review, …