Search results for " usp" in Articles / App Notes
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Setting Standards for Biotech Therapeutics in India
IPC and USP have been working closely together and organize an annual conference to share updates and ideas. Similar relationships need to be pursued with other global agencies such as National Instit…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
USP, USP General Chapter , “Development and Design of Biological Assays,” USP 35-NF 30:162 (US Pharmacopeial Convention, Rockville, MD, 2010), pp. 1-36.
29. X.R. Jiang et al., Nat. Rev…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
USP, Bovine Serum Appendix 1, USP 38–NF 33 (US Pharmacopeial Convention, Rockville, MD, Oct. 1, 2015), pp. 719.
8. European Pharmacopoeia, Monograph: Bovine Serum, 01/2008:2262, pp. 1…
Article
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
BioPlan studies have shown that few processes are scaled-up, particularly for commercial good manufacturing practice (GMP) manufacture, using perfusion in continuous upstream bioprocessing CP USP. Per…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this stu…
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
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
The use of Xcellerex™ mixing system as slurry tank when packing chromatography columns
The system is complete with motor and controls, and an irradiated USP Class VI, single-use, low-density polyethylene plastic bag equipped with a disposable bottom-mounted impeller. The connection betw…