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Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Because of the risks associated with live and inactivated viruses, namely potential attenuation reversal or failure of inactivation, recombinant viruses have emerged in the role of either vaccines or …
Article
Leveraging Data for Better Biopharmaceutical Process Control
IFPAC 2018 already showed this year several talks on MS-based multiple attribute methods (MAM), a new acronym being used by FDA’s Emerging Technology Team (ETT) to name the PAT use of these methods.
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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 …