Search results for " documentation"
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Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
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Outsourcing Trends in Biopharmaceutical Manufacturing
Other problems can arise, such as a lack of consistency in bioprocessing and regulatory documentation, which in turn lead to delays in product development, approvals, and manufacturing.
Trend eigh…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
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Early Communication with Regulators is Essential for SMEs
“Quality documentation continues to be a problem area for many SMEs, particularly relating to manufacturing process validation, the setting of specifications, and stability data,” says the SME Office …
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Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
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Essentials in Establishing and Using Design Space
Visualization, documentation, and communication of the design space helps to assure the product and or process set points are well defined and within safe and robust operating regions. Design space sh…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The aim of this white paper is to demonstrate how Cytiva single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vacci…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Linking unit operations through tandem processes would eliminate this constraint and additionally may reduce process time, process costs, and documentation requirements. Feasibility has been demonstra…