Search results for " industry"
Article
Re-use of Protein A Resin: Fouling and Economics
While all five of the parameters are used in the industry, yield is considered as the most important, followed by impurity levels, product quality, chromatographic profile, and HETP. Other than these …
Article
New Era for Generic Drugs
8-10
The 30th anniversary of the Hatch-Waxman Act in September generated widespread recognition of how the legislation created today’s vibrant generic-drug industry. Generic drugs now account for m…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
Article
Challenges and Trends in Biopharma Facility Design
Philips (Pall Life Sciences): With the current cost pressures facing the industry, the number one challenge for biopharmaceutical companies can often be determining the economic viability of a facilit…
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Applying GMPs to the BioPharma Supply Chain
There is an acknowledged gap between current capabilities of many suppliers and what will be needed in the future to support the industry in an increasingly demanding regulatory and end-user focused m…
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Quality by Design—Bridging the Gap between Concept and Implementation
Nonetheless, the pharmaceutical industry has been internally adopting the QbD concepts laid down in the guidelines of the International Conference on Harmonization (ICH) covering pharmaceutical develo…
Article
Report from India
…ines are available to those who need them most by managing prices in the retail market and balancing industry growth on a longer-term perspective."
Impact on consumers
While consum…
Article
Flexibility in Biopharmaceutical Manufacturing
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanufacturing industry that product quality, customer service, and cost efficiency are fundamentals for suc…
Article
Advancing QbD in the EU
The pharmaceutical industry in Europe sees QbD concepts as reflecting existing practices in the sector. Introducing them in regulations and guidelines gives more emphasis to the important elements in …
Article
Quality by design for biotechnology products—part 1
Guidance for industry: Q9 Quality risk management. Bethesda, MD; 2006.
3. US FDA. Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda, MD; 2006.
4.…