Search results for " biotech"
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
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Bureaucratic Roadblocks Threaten Biopharma Growth
The good news is that some mature and emerging economies are making growing use of patent systems to facilitate biotechnology research and commercialization. The bad news is that a number of countries…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
Many of the largest branded biotech products in the US market today are now in biosimilar development by at least one company, Levesque says, and the pipeline is expanding. Blockbuster biotechs facing…
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FDA Seeks Metrics to Define Drug Quality
The filings indicate that pharmaceutical and biotech companies regularly monitor error rates, for example, to identify non-conformances, discrepancies, and deviations; high error rates are considered …
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Going Viral? Developing scalable viral vector manufacturing
Calling all Biotech Makers! We invite you to join our next interactive workshop where we have panellists from Virocell, AGC Biologics, Sensorion Pharma and Cytiva ready to share their kno…
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Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
Cytiva will provide its FlexFactory, a flexible, single-use platform, to enable Akron Biotech to manufacture plasmid DNA (pDNA), which is used in many innovative therapies and vaccines, Cytiva said in…
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Addressing the Complex Nature of Downstream Processing with QbD
When it comes to early development, Doug MacDonald, senior scientist at Seattle Genetics, a biotech company that develops and commercializes cancer therapies, states that “speed to clinic” can inhibi…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Andy Racher, associate director future technologies, Lonza Pharma & Biotech. Today, however, cell titers have been reported at levels in excess of 10 g/L, he says.
This resulted from the introd…
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Biopharma Seeks Balance
According to a Biotechnology Innovation Organization report (1) overall investment trends for R&D-stage companies were up in 2017 compared with 2016, despite a drop in the number of acquisitions. Gile…
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Applying GMPs in Stages of Development
This procedure, regardless of whether the product you are investigating is biotech or traditional, or new or old, should require the investigator to review various systems and determine whether they w…