Search results for " pharmaceutical" in Articles / App Notes
Article
Traceability in Western Blot Imaging: Considerations for GxP
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Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…
Article
Updating Viral Clearance for New Biologic Modalities
ASTM, “Proposed Standard for Inactivation of Enveloped Viruses Being Developed by ASTM Pharmaceutical Committee,” Press Release, March 4, 2013.
2. ICH, Q5A Quality of Biotechnological Products: Vi…
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ISPE Releases Cleaning Validation Guide
The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitione…
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Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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Advances in Engineering of Protein-Based APIs
Bi/multispecific proteins
Bispecific antibodies are an important emerging area in advancing protein engineering for pharmaceutical products, and several bispecifics based on immunoglobulin scaffol…
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Supply Chain Challenges for Single-Use Systems
… in November 2018, Cytiva announced a collaboration with Chinese healthcare technology supplier Wego Pharmaceutical to produce single-use consumables in Weihai, China using Cytiva’s Fortem platform f…
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Cytiva Opens Biotechnology Manufacturing Center in UK
GE Healthcare Opens Biotechnology Manufacturing Center in UK
Cytiva is opening a biotechnology manufacturing center at the Stevenage Bioscience Catalyst (SBC) Open Innovation Campus, in Stevenage…
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A Plastic Pipeline for Commercial Bioprocessing?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
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Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
New problems, new solutions
An ongoing pharmaceutical industry trend has been the adoption of faster and more sensitive glycoanalytical workflows. Over the past few years, several commercial suppl…