Search results for " information"
Article
What Drove Biopharma Development in 2014?
The global monoclonal antibody market size exceeded $80 billion in 2013, and could reach $141 billion by 2017, according to Paradigm Global Events, an independent business information provider.
PD…
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Mechanistic Modeling: Does it Have a Future in Process Development?
What is the benefit of having the information about physical properties?
If you have a mechanistic model, you know that all the correct parameters are part of your model if you have made the right …
Article
Improving PAT for Biologics
“We are excited about the use of Raman and NIR probes for biopharmaceutical manufacturing because these probes have the ability to provide real-time information about the process and product in the bi…
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Evaluating Design Margin, Edge of Failure and Process
In this respect, limits are justified based on critical information gained from the entire process spanning the period from early development through commercial scale production.”
Table I: Measu…
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Pharma Investments Reflect Key Industry Trends
Bristol-Myers Squibb (BMS): BMS is consolidating more than 575 jobs in information technology, marketing services, and financial services at its new North America Capability Center over the next three…
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Relationship Building at Top of Mind for Clients
Clients are seeking an increasing volume of available information about CMOs before they begin their due diligence. This type of vetting process allows for potential problem areas and questions to be …
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
The gene functions were obtained from the website of the National Center for Biotechnology Information (www.ncbi.nlm.nih.gov/gene).
Results
Concentrated feed medium M1 test in shake flask…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In 2012, the EMA also published final guidance, the non-clinical and clinical requirements for biosimilar mAbs, including information on pharmaco-toxicologic, pharmacokinetic, pharmacodynamic, efficac…
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Design of Experiments for Analytical Method Development and Validation
Analyst name, equipment ID, out time, hold times, ambient temperature, temperature at the beginning and end of an operation, transfer times, pH, and incubation time may hold valuable information on fa…
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FDA and EMA Extend QbD Parallel-Assessment Pilot Program
FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parallel evaluation of quality-by-design (QbD) applications for two years beginning April 1, 2014. In the jo…