Search results for " standardization"
Article
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
Article
NIST Spectroscopic Measurement Standards
NIST Spectroscopic Measurement Standards
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance mea…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
…
Article
USP Stresses Pharmacopeial Standards at CPhI China
Jun 29, 2015
By BioPharm International Editors
The United States Pharmacopeial Convention (USP) hosted a pharmacopeial and regulatory compliance seminar at the 2015 CPhI China conference, he…
Article
Video: Standardize recombinant protein purification process development
Cytiva™ Protein Select™ resin is an affinity chromatography resin for purifying recombinant proteins using the self-cleaving Cytiva Protein Select tag. During an affinity step performed with C…
Article
EMA Confirms Standards for COVID-19 Treatment Evaluations
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicine…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The lack of standardization in both instrumentation and data management is still hindering progress in this area, however.
Standardization for instruments involves both communication protocols and…
Article
Advancing Single-Use Technology Through Collaboration
In order to facilitate the adoption of single-use systems for commercial manufacturing, standardization of extractables testing is needed. For these reasons, many representatives from industry joined …
Article
GMP Challenges for Advanced Therapy Medicinal Products
“Manipulation of cells and use of recombinant nucleic acids may bear unknown risks, which may not be solvable through standardization or quality control,” Salmikangas added.
A major problem area wi…