Search results for "Training"
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Pharma Investments Reflect Key Industry Trends
Roche is also spending $105 million on a new packaging and logistics training center in Switzerland.
Sanofi: Sanofi is investing in emerging markets. The company is not only increasing insulin pro…
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Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
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Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
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Early Communication with Regulators is Essential for SMEs
The companies are being offered free or heavily discounted regulatory and administrative assistance, training sessions, evaluation, and above all, scientific advice that can raise the chances of a new…
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Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
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Operational Excellence: More Than Just Process Improvement
The ultimate goal was not simply to make the processes compliant, but to create sustainable improvement by training all stakeholders, not just a targeted few; increasing collaboration and partnership …
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Elucidating Biosimilars Characterization
BioPharm International spoke with Jonathan Bones, principal investigator at Ireland’s National Institute for Bioprocessing Research and Training (NIBRT); Reg Shaw, PhD, CEO of NIBRT (collectively refe…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
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Essentials in Quality Risk Management
An implementation plan with tools, training, and standard operating procedures are needed to build a low-risk development and manufacturing platform. Management involvement is needed to trigger risk-a…