Search results for " pharmaceutical"
Article
Mechanistic vs Statistical Models
Mathematical models are recommended by the ICH Q8 guidelines on pharmaceutical development to generate enhanced process understanding and meet Quality-by-Design (QbD) guidelines. Read on the d…
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Optimization of a Two-Step Purification Method for Bispecific Antibodies
Alligator Bioscience AB develops antibody-based pharmaceuticals for cancer treatment, specializing in mono- and bispecific antibodies for tumor-directed immunotherapies. Alligator and Cytiva devel…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Chahal, Pharmaceutical Bioprocessing, (2014).
5. R. Kunert and D. Reinhart , Appl Microbiol Biotechnol, 100 3451–3461 (2016).
6. R. Gilbert, Cell & gene therapy insights, 6 (1) 143-148 (2020).…
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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…
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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…