Search results for " quality"
Article
Regulatory Challenges in the QbD Paradigm
Implementation of quality by design (QbD) in this environment has further contributed to the need to clarify what information needs to be included in a regulatory filing and how it should be presented…
Article
Operational Excellence: More Than Just Process Improvement
In addition to increased efficiency and cost reduction, there is a third leg to the stool: quality and compliance benefits. With carefully designed, executed, and sustainable operational excellence pr…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Apheresis center capacity, donor network access, sample handling expertise, and quality control systems all contribute to the ability to achieve reproducible starting material quality and efficacy.
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Article
Avoiding Investigational Failures and Discrepancies
This investigational infraction, which resulted in the issuance of a Form 483 Investigational Observation from FDA, serves as an illustration that if a company does not perform its quality due diligen…
Article
QbD and PAT in Upstream and Downstream Processing
UPSTREAM PROCESSING
BioPharm: In implementing QbD, what would you identify as the critical quality attributes (CQAs) in a typical upstream bioprocess using cell-culture?
Vanden Boom (Hospi…
Article
Good Manufacturing Practices: Challenges with Compliance
By Lauren Lavelle
BioPharm International spoke to Lauren Smith, senior director of quality, Catalent; Judy Cohen, vice-president of Quality and Regulatory at Lubrizol Life Science’s …
Article
Understanding Validation and Technical Transfer, Part I
Therefore, the manufacturing and purification processes become critically important in ensuring the “sameness,” quality, efficacy, and safety of these products.
Process validation is documented…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Product safety and quality by design (QbD)
Traditionally, product safety has relied on the incorporation of three key measures into the manufacturing process: selection, testing, and viral clearan…
Article
Best Practices for Selecting a Top-Quality Cell Line
Challener
Cell lines determine the performance of bioprocesses and the quality of the biologic drug substances they produce. As such, selection of the optimum cell line for each specifi…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Issue 7, pg 34–36
BioPharm International spoke with Stephan Krause, director of quality assurance, Laura Jeannel, asso…