Search results for " PDA" in Articles / App Notes
Article
Global Expansion Shapes Drug Oversight
ISPE and PDA are working with European associations and regulators to craft a plan that addresses shortage-related quality issues relevant to the European market.
Global expansion has been a promin…
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Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
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Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
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Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
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Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Speed and Flexibility Are Dual Goals for Biopharma Operations
Bioprocessing facilities, equipment, and materials, as well as strategies to improve biopharmaceutical development and manufacturing, were featured at INTERPHEX 2017, held in March in New York City.…
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Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …
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Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
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Aseptic Processing: Keeping it Safe
Acucena, “Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes of Investigational Medicinal Compounds,” presentation at the PDA Metro Chapter Dinner, March 4, 2014.