Search results for " specification"
Article
Being Thorough When Transferring Technology
This becomes invaluable to others later, and helps support claims for process characterization and robustness; selection of control and critical parameters; and setting of specifications. A summary of…
Article
Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
Article
Implications of Cell Culture Conditions on Protein Glycosylation
ICH, Q6B, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, Step 5 version (Sept. 1999).
About the Authors
Michiel E. Ultee, PhD, is principal at …
Article
Evaluating Design Margin, Edge of Failure and Process
…as % of Tolerance = (Mean Response - Nearest Limit) / (USL-LSL)
Edge of Failure
USL is upper specification limit. LSL is lower specification limit.
Edge of failure is defined as the point…
Article
Regulatory Challenges in the QbD Paradigm
Product specifications in the traditional approach are set based on process performance, and regulators expect them to be narrowed after enough process history has been established. On the other hand,…
Article
PDA's Technical Report for Biotech Cleaning Validation
…le to assess the suitability of the cleaning program to consistently clean equipment to the required specifications.
RISK MANAGEMENT AND ASSESSMENT
Quality risk management (QRM) involves elem…
Article
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…