Search results for " meeting" in Articles / App Notes
Article
Challenges and Trends in Biopharma Facility Design
… that best minimizes capital investment and long-term operational costs in the facility, while still meeting the production needs the company has.
In the case of producing a blockbuster drug, a l…
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FDA Seeks Metrics to Define Drug Quality
Woodcock acknowledged at the FDLI meeting that intensive regulation of drug manufacturing is partially to blame for industry’s reluctance to implement innovative quality strategies. While producers of…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Cell-based vaccine production with well-characterized processes can be a solution to meeting the capacity requirements. It also has its advantage in shorter production time compared to egg-based produ…
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Enhancing Resins Addresses Purification Concerns
He says that the types of porous beads, with their variety of construction materials, bead, and pore sizes, are rather well-advanced in meeting key market needs. New base matrix designs could be seen …
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Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…
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How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
The meeting attracted a record number of participants, reflecting heightened industry interest in discoveries that promise to revolutionize the treatment of serious health conditions. Participants exp…
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Being Thorough When Transferring Technology
Does the company have the capacity, the equipment, and the capital for the project? If not, is it committed to having a plan in place to meet a client’s timeline while meeting quality and cost expecta…
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Drug Quality Key to Innovation and Access
… standards and how written agreements should map out the roles and responsibilities of each party in meeting those goals.
Industry and FDA will face challenges as they continue to implement drug …