Search results for " PDA"
Article
PDA's Technical Report for Biotech Cleaning Validation
As discussed in the recently published PDA Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation, well–designed laboratory-scale studies can be performed using design of ex…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…tool, similar to what is published in Parenteral Drug Association (PDA) Technical Report (TR) 44 and PDA TR 54 (for biopharmaceuticals) (3, 4). An FMEA is appropriate for managing risks for processes…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Mittelman and Anicetti are co-chairs of the Parenteral Drug Association task force that developed the bioburden and biofilm technical report titled, PDA Technical Report No. 69, (TR 69) Bioburden and …
Article
Challenges in Analytical Method Development and Validation
FDA used much of PDA TR 57’s content for their current draft guidance.
Guo (FDU): The International Conference on Harmonization (ICH) has a general guidance on method validation, ICH Q2(R1): Valida…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
(DHI Publishing, PDA Books, 2014).
17. M. Gietl, B. Meadows, and P. Lopolito, “Cleaning Agent Residue Detection with UHPLC [7]” Pharm. Manufacturing (April, 2013), accessed Oct. 10, 2017.
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Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
J Skrine, PDA J Pharm Sci Technol, 65 (6), pp. 599-611 (2011).
14. Genzyme press release.
15. M. Moody, et al., PDA J Pharm Sci Technol 65 (6), pp. 580-588. (2011).
…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Nims, PDA J. Pharm. Sci. Tech. 64, pp. 481–485 (2010).
22. M. Plavsic et al., Bioprocess. J. 9 (2), pp. 6–12, (2011).
23. Y. Qiu et al., Biotechnol. Bioeng.110 (5), pp.…
Article
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Modular Manufacturing Platforms for Biologics
Using the same equipment for development and manufacturing could help minimize technical transfer costs and resources, he wrote in his PDA presentation notes, and could reduce inventory overheard whil…