Search results for " guide" in Articles / App Notes
Article
CoAs Help Secure the Supply Chain
IPEC, Certificate of Analysis Guide for Pharmaceutical Excipients, International Pharmaceutical Excipients Council (IPEC, 2013).
2. WHO, Guidelines on the Implementation of the WHO Certification…
Article
Preclinical Evaluation of Product Related Impurities and Variants
The selection of resin, as is known, is guided by the physicochemical properties of the mAb product under investigation. In this case study, the mAb product had the following characteristics: pI, 7.9-…
Article
3rd BioProcessing Asia Preview: Q&A with John Curling
They all have long-term experience in biopharmaceutical development in Asia and iconic academics with consultative roles will guide the BPA 2018 program.
The session titles have also recently be…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
These correlations, and thresholds, are then used to guide inventory stocking and business continuity planning.
Using demand to track risk
Demand and planning can be used to track risk. The RRs…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
… and commercialize new technologies; and regulators ensure that new advancements conform to existing guidelines or develop new guidelines in collaboration with industry, if required. Thus it is impor…
Article
Being Thorough When Transferring Technology
The technology transfer procedures implemented are typically guided by International Council for Harmonization (ICH) Q10 or equivalent guidance from other regulatory authorities. This guidance is prac…
Article
Managing Risk in Raw Material Sourcing
“Our efforts are focused on compliance with the International Council for Harmonization’s (ICH) Q7 (for APIs) and IPEC (for bulk pharmaceutical excipients) guidelines to continuously improve our syste…
Article
Affinity chromatography Handbook - Vol. 3: Specific Groups of Biomolecules
Practical information is given as a guide towards obtaining the desired results.
Download the handbook
Article
Framing Biopharma Success in 2016
Industry feedback to the draft guidance reflected concerns about how FDA will use the reported data to guide further regulatory action, what players in the supply chain were responsible for reporting …
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
These findings from PCA were used to guide selection of a process subspace to characterize and optimize. Eleven factors were selected: two pH parameters, four amino acid concentrations in the feed, an…