CONTINUOUS PROCESSING OPTIMIZATION WITH SMARTER TOOLS

Posted on May 18, 2018

Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost effective ways to produce drugs for the patients who need them. As orphan drugs and personalized medicine begin to replace traditional blockbuster products, pharmaceutical companies are looking at new and innovative ways to quickly and […]

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Single-Use & Stainless Steel Bioreactors : Quality Factors For Consideration When Selecting A Suitable System

Posted on May 18, 2018

Introduction Single-use (SU) systems are now in common use in pharmaceutical bioprocessing, as well as in other related technologies such as the manufacture of diagnostics and other biological products, and their popularity is increasing. Some types of SU systems have been in use for many decades now. The earliest SU systems being disposable filter cartridges […]

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Implementation Strategies And Challenges For Single-Use Technologies At Commercial Scale

Posted on May 18, 2018

Background For over 10 years, single-use technology (SUT) has been a growing buzzword in the biomanufacturing industry for its advantages in speed, flexibility, and cost. A recent 2015 BioPlan Associates, Inc. industry survey of biopharmaceutical manufacturers, contract manufacturing organizations, industry vendors, and direct material suppliers identified the ‘Top Concerns’ for why biopharmaceutical manufacturers are choosing […]

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The future of biomanufacturing

Posted on May 11, 2018

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible multi-product facilities using single-use technology. Though single-use is being widely adopted, there still exists a lag in automation and measurement to make the most use of the technology and data integration. Next challenges in biomanufacturing The next set […]

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Changing Column Packing From An Art Into A Science

Posted on May 11, 2018

Chromatography is often the most critical step in biopharmaceutical downstream processing because of its role as the engine for separating impurities from target biologics. The most demanding operation in production scale chromatography is typically packing the column in a way that ensures first time success and a validation result which meets the batch record standards. […]

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Sterile Products Manufacturing- Prepared For The Future?

Posted on May 11, 2018

Introduction Traditionally aseptic processing has been a niche area in the pharmaceutical industry. The big majority of pharmaceutical products were manufactured as tablets or capsules and the standard formulation would be as a dry or wet powder mix, granulation etc. under pragmatic room classification conditions and quite effective for large product volumes. From a volume […]

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Facilities For Personalised Medicine In The Most Personal Form – Today And Tomorrow

Posted on May 11, 2018

When redoing the batch is not an option There is a paradigm shift underway in which big pharma mass production of products for specific diseases is deviating towards the ‘batch of one.’ These autologous therapies are patient-specific and there may only be one chance to harvest the patient’s cells and return the personalised drug to […]

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