Search results for " market"
Article
Labeling of Biosimilars
…eached a key stage in the lengthy process of creating a regulatory framework for the development and marketing of biosimilars in Europe. In December 2014, guidelines on quality standards for biosimil…
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Optimizing Resin Performance with Disposable Chromatography Solutions
…r product manager of antibody affinity media, Cytiva; and Steve Tingley, vice-president of sales and marketing, bioprocessing, Repligen about current trends in disposable chromatography and how the t…
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Bureaucratic Roadblocks Threaten Biopharma Growth
…dermine the drug development and patenting process and may impede the delivery of novel medicines to market.
Despite the 2010 declaration by the then-President of India that the next 10 years w…
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Regulatory Challenges in the QbD Paradigm
Under the QbD paradigm, the success or failure of a marketed pharmaceutical product is assessed to incorporate lessons learned into future reviews of drug applications.
An integrated model of re…
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Moving PAT from Concept to Reality
Overall, therefore, PAT contributes to acceleration of process development timelines for reduced time to market, concludes Carbonell.
PAT should also ultimately make real-time product release poss…
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The Challenge of Disruptive Technologies in Bioprocessing
“When we look at the biologics market dynamics for treatment of diseases, certainly the increasing demand for biopharmaceuticals and the growing R&D expenditure in biopharma companies are factors driv…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The global biopharmaceuticals market was valued at $162 billion in 2014 and pre¬dicted by Persistence Market Research to grow at a compound annual growth rate of 9.4% from 2014 to 2020 to reach $278 b…
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Improving Process-Scale Chromatography
She points to several new types of affinity chromatography resins introduced to the market in recent years that target recombinant plasma proteins, gene therapy applications, and different types of an…
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Biopharma in 2015: A Year for Approvals and Innovations
The EU was the first geographic market to develop the process of authorization of biosimilars, setting an example for many other developing markets to follow suit. As of 2015, the EU approved 19 biosi…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
Pre-litigation steps for biologics has been set out by the BPCIA, wherein a biosimilar sponsor may challenge an unexpired patent in an attempt to enter the market before the originator patent expires.…