Search results for " name" in Articles / App Notes
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Platform Technologies Improve Protein Expression
…dium, growth conditions, equipment, scalability, stability, and matching purification capability, to name but a few. Primary drivers to the development of a new therapeutic protein platform are the d…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Factors that play a role in media design originate from three major sources, namely the attributes of the product under consideration, the cell line that is being used for protein production, and the …
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
Contract Manufacturing Through the Years
Big name private equity firms such as Black Rock (Catalent), KKR (Capsugel) and JLL Partners (Patheon) became important presences in the industry.
External funding for emerging bio/pharma …
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Drug Quality Key to Innovation and Access
The International Council for Harmonisation (ICH) has changed its name to reflect expanded involvement of health authorities from additional regions and of manufacturers representing additional indust…
Article
Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
This method, widely named trypsinization, is based on the addition of an active concentration of the enzyme to the cell culture and subsequent digestion of cell-membrane proteins that establish the in…
Article
Fluid Handling in Biopharma Facilities
…g, which is inert, odorless, withstands autoclaving, and is translucent for flow visibility, just to name a few benefits.
Fluid Handling Innovation
BioPharm: What types of innovation would you …