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Pharmaceutical Technology, December 2021 Issue
Digitalization Moves Forward in Pharma Equipment and Processes
December 03, 2021
Cover Story
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Bio/pharmaceutical manufacturing harnesses the benefits of digital transformation.
Digital Transformation Project Reduces Downtime
December 03, 2021
Cover Story
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Polpharma implemented digital technologies, including a digital twin of operations.
Using Tolerance Intervals to Assess Conformance to Requirements
December 03, 2021
Peer Reviewed
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The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.
It’s a Matter of Taste-Masking
December 03, 2021
Development
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Increased patient-centricity and alternative dosage forms require careful consideration when selecting the best taste-masking approach.
Stabilization of Amorphous APIs
December 03, 2021
Development
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Polymeric amorphous solid dispersions are the most commonly used technology, but amorphous APIs remain inherently unstable.
Trends in Isolator Equipment
December 03, 2021
Manufacturing
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Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.
Analytics Advances for Optimizing Downstream Processes
December 03, 2021
Manufacturing
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Simple, inexpensive real-time analytics are urgently needed for high value products.
Looking Past the Pandemic: The Future of GMPs in Aseptic Processing
December 03, 2021
Quality
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While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.
Not a Particle of Doubt
December 02, 2021
Analytics
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Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.
Accelerating Project Delivery with a Lean Alternative to DBB
December 02, 2021
Operations
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Lean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.
The Key Elements for Assay Transfer Success
December 02, 2021
Outsourcing
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Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.
Spinning Success? The Benefits of University Spinouts
December 02, 2021
From The Editor
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Pharma and biotech are ruling the roost in terms of university innovation, but European spinouts are still experiencing barriers to long-term success.
Pandemic Alters Policies and Practices for Drug Development and Regulation
December 02, 2021
Regulatory Watch
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The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Breaking the Rules
December 02, 2021
From The Editor
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We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.
Frequently Asked Questions About Quality Control vs. Quality Assurance
December 02, 2021
Ask the Expert
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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.
Single-Use Separator
December 02, 2021
Product Spotlight
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The GEA kytero combines the high performance of larger GEA stainless-steel pharmaceutical centrifuges with the benefits offered by disposable components.
Versatile Mass Detector
December 02, 2021
Product Spotlight
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Relative to prior models, the Thermo Scientific Orbitrap Exploris MX mass detector provides reduced downtime and maintenance, superior data quality, and seamless method transfers.
Multi-Shaft Mixers
December 02, 2021
Product Spotlight
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ROSS VersaMix Multi-Shaft Mixers provide fast and efficient large-scale powder dispersion.
Ten-Lane Capsule Checkweigher
December 02, 2021
Product Spotlight
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Anritsu's 10-Lane Capsule Checkweigher can inspect up to 75,000 capsules per hour.