Search results for " specification"
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Q6B, Specifications: test procedures and acceptance criteria for biotechnological/biological products. Geneva, Switzerland; 1999.
4. US Food and Drug Administration. Guidance for industry. Points …
Article
Essentials in Quality Risk Management
…file (QTTP), through CQA generation to analytical method selection, unit operation characterization, specification and acceptance criteria limit generation, critical process parameters and control se…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
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Article
Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
Article
Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
Article
Boosting biopharma resilience: The need to shift focus and increase collaboration
Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength an…
Article
Top challenges in recombinant protein purification process development
In this video, Emma Lind, Product Manager for Chromatography Resins at Cytiva answers questions from BioPharm International about the challenges faced by process developers working with recombi…
Article
As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
Development beyond traditional monoclonal antibodies (mAbs) is increasing, and today, we see antibody variants like multispecific and bispecific antibodies and antibody fragments. In mAb proc…
Webcast
Trace metals getting you down? Learn what’s really in your cell culture media with Cytiva.
Our Targeted Cell Culture Media Manufacturing program predicts and manufactures cell culture media consistently within your specification range with no change to your formulations.