Search results for " case study"
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The Sidebar describes a VRL case study for a biopharmaceutical facility.
Sidebar: visible residue limit case study
A large biopharmaceutical manufacturer was desi…
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
nobeastsofierce/Shutterstock.com
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Article
Preclinical Evaluation of Product Related Impurities and Variants
In this case study, the mAb product had the following characteristics: pI, 7.9-8.2; size, 149 kDa; origin: Mus musculus. Based on this information and prior experience, porous HS resin (Sulphopropyl -…
Article
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…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
CMC Biotech Working Group, A-Mab: A Case Study in Bioprocess Development. October 2009, accessed June 5, 2014.
10. S. Kozlowski, “Implementation Activities for QbD: FDA Office of Biotechnology Pro…
Article
Quality by design for biotechnology products—part 1
Defining design space for biotech products: Case study of Pichia pastoris fermentation. Biotechnol Prog. 2008:24(3):655–62.
19. Godavarti R, Petrone J, Robinson J, Wright R, Kelley BD. Scale-down …
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The present case study shows that film-manufacturing parameters can be controlled to manufacture, from a cell-culture perspective, high-quality and low-quality films.
Materials and Methods
Res…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
A comprehensive case study of the application of QbD principles to the development of a mAb product (A-mAb) has recently been published that describes extensive use of scale-down models to gain proces…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…