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Pharmaceutical Technology, November 2021 Issue
The Earlier the Better for Formulation Strategies
November 03, 2021
Cover Story
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Investing in formulation strategies earlier on in development will maximize the chance of success.
Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process Data
November 03, 2021
Peer-Reviewed
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Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a reduced number of false alarms.
Taking an Alternative Approach to Drug Delivery
November 03, 2021
Development
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Alternative drug delivery approaches are promising, but due to their complexity, they need to be sufficiently justified.
Computational Fluid Dynamics in Upstream Biopharma Manufacturing Processes
November 03, 2021
Manufacturing
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Advances in simulation and the development of digital twins.
GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 Pandemic
November 02, 2021
Quality/Regulations
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An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
Visual Inspection: Seeing Room for Improvement?
November 02, 2021
Quality/Regulations
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Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.
Detecting and Determining Quantitation Limits for Impurities
November 02, 2021
Analytics
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Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.
Labeling Efficiently
November 02, 2021
Manufacturing
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Machine and material innovations yield more efficient, sustainable processes for pharmaceutical packaging, including vaccine vials.
Meeting Supply and Training Challenges
November 02, 2021
Manufacturing
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Best practices help mitigate generic drug shortages.
Pandemic Alters FDA Inspections and Quality Oversight
November 02, 2021
Regulatory Watch
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New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
Lipids for Self-Emulsifying Drug Delivery Systems
November 02, 2021
Development
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SEDDS and SMEDDS improve solubility and permeability while expanding efficacy and applicability.
Making a Difference in European Bio/Pharma
November 02, 2021
From The Editor
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Manufacturing capacity expansion is high on the agenda for many bio/pharma companies and service providers in Europe.
The Remote Audit–A Tongue-in-Cheek Memo
November 02, 2021
Ask the Expert
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Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.
Wraparound Vial Labeling Machine
November 02, 2021
Product Spotlight
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WL-1-RT Wraparound Vial Labeling Machine can label up to 600 vials per minute.
ADCC Expression Cell Line
November 02, 2021
Product Spotlight
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The ADCC+ Cell Line is designed for rapid identification of clones expressing high levels of recombinant therapeutic proteins.
Liquid Pharmaceutical Checkweigher
November 02, 2021
Product Spotlight
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The Mettler-Toledo StarWeigh checkweigher provides fill level measurements of products like glass and plastic bottles, vials, and ampules.
Pressure Feed Vessel
November 02, 2021
Product Spotlight
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The ROSS Ribbon Blenders ensures even mix and consistent batches.