Search results for " comparability"
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
Article
Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing.
By: Randi Hernandez
Whil…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
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…
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Challenges in Analytical Method Development and Validation
Besides providing sufficient qualification or validation results for the new method, method comparability results should also be provided. In some cases, product specifications may need to be re-evalu…
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Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…
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Outsourcing Trends in Biopharmaceutical Manufacturing
The author highlights the top 10 outsourcing trends revealed during a survey of biopharmaceutical manufacturers.
The biopharmaceutical industry is changing the way it manufactures. According to …
Article
EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe.
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Establishing similar run conditions at multiple scales is an important consideration when trying to qualify the comparability between full-scale and small-scale experiments. Substantial prior experien…