Search results for " development" in Articles / App Notes
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
The years 2008-2012 were more about implementing QbD with the industry incorporating the various elements of QbD into its approaches of process and product development. This phase also included discus…
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Bureaucratic Roadblocks Threaten Biopharma Growth
There is a clear link between a country’s rate of economic development and the strength of its intellectual property laws. This is particularly true in knowledge-intensive sectors such as biopharmaceu…
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EMA Collaborates with HTA Assessment Networks
…network, on involving HTA bodies in giving advice to manufacturers in the early stages of a drug’s development.
The move has been welcomed by small- and medium-sized enterprises (SMEs), especia…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
With the aim of helping to stimulate the global development of these medicines, the EU has opted for more flexibility in the choice of the original biopharmaceutical or reference product to which biop…
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Biotechnology Innovation and Growth in Israel
Even though Israel, which joined the Organization for Economic Co-operation and Development (OECD) in 2010, has seen accelerated health spending since 2009, national expenditures on health remain lowe…
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Elucidating Biosimilars Characterization
While many companies are keen on getting a share in the biosimilars market, bringing these complex molecules from bench to launch can be a challenge, not just during the development stage but also in …
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PDA's Technical Report for Biotech Cleaning Validation
The report uses a life-cycle approach to biotechnology cleaning validation that encompasses design and development, process qualification, and ongoing control of effectiveness. It also considers the r…
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Webinar: Intensifying downstream bioprocessing with continuous technologies
Webinar on June 20, 2024
Significant operational improvements can be achieved by intensified continuous processes compared to standard batch processes.
In this webinar we will explor…
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Alternative solutions to separate AAV full and empty capsids using anion exchange
Adeno-associated virus (AAV) is the main vector for gene therapy and there is need for scalable, cost-efficient, and robust chromatography-based purification. Key for a successful process are …
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Exploring the world of antibodies: mAbs, Fabs, dAbs, and bsAbs
There is a vast array of antibody variants, including multispecific (msAb), bispecific antibodies (bsAb), antibody fragments (Fab, dAb, scFv), and antibody-drug conjugates (ADC). But with this…