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Pharmaceutical Technology-10-02-2020
Pharmaceutical Technology
Unique Molecules Push Formulation Boundaries
October 03, 2020
Cover Story
44
10
More complex and challenging compounds require a more tailored approach to formulation strategies.
Development of a Validated Method of Testing for NDMA in Ranitidine
October 03, 2020
Peer-Reviewed Research
44
10
This article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.
Masking Taste: A Key Attribute to Success
October 03, 2020
Development
44
10
Taste-masking can be of significant importance in ensuring success of a drug product, particularly those targeted to pediatric or geriatric populations.
Factoring Stability in the Biologic Drug Mix
October 03, 2020
Development
44
10
Excipients must be carefully chosen to ensure optimum protection for vaccines and live biotherapeutic products.
Improving Agility Through Scalability
October 03, 2020
Manufacturing
44
10
Research is striving to make pharmaceutical processes more scalable by making them simpler and easier to replicate and control. Advances include 3D printing, as well as miniaturized and continuous processes, all of which are being aided by improved automation and analytics.
Modernizing Bioprocessing for Gene Therapy Viral Vectors
October 03, 2020
Manufacturing
44
10
The manufacture of gene therapy vectors is shifting to more modern technologies.
Scaling Up Fast
October 03, 2020
Manufacturing
44
10
Industry experts discuss challenges and best practices for scaling up manufacturing under a short deadline.
Viewpoint: Digitizing Processes to Align with GMP Requirements
October 02, 2020
Quality/Regulations
44
10
The case for migrating from a paper-based quality management system to a digital platform is presented.
Unlocking the Key Changes to Annex 1
October 02, 2020
Quality/Regulations
44
10
A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.
Strategizing for Rapid Changeovers in Biologics Manufacturing
October 02, 2020
Operations
44
10
Facility and equipment design are important, but the team and its experience matter most.
Securing the Pharmaceutical Supply Chain with Full Traceability
October 02, 2020
Operations
44
10
End-to-end traceability can provide more value than just securing drug product safety.
Cellular and Gene Therapies Face a Manufacturing Capacity Crunch
October 02, 2020
Outsourcing
44
10
Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.
Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?
October 02, 2020
Regulatory Watch
44
10
Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
Regulating with Flexibility: The Pandemic Effect
October 02, 2020
Regulatory Watch
44
10
Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.
Fighting the (Dis)Information Pandemic
October 02, 2020
From The Editor
44
10
Misleading messages contribute to eroding trust in public health agencies.
The Elephant (or Donkey) in the Room
October 02, 2020
From The Editor
44
10
European pharma companies may have a vested interest in the outcome of the US elections.
Writing Effective SOPs
October 02, 2020
Ask the Expert
44
10
The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.
Automated Perfusion System
October 02, 2020
Product Spotlight
44
10
Cytiva announced that it is launching the Xcellerex Automated Perfusion System (APS), a device aimed at simplifying processes and reducing risks when intensifying upstream operations.
1000-Gallon Pivoting Triple Shaft Mixer
October 02, 2020
Product Spotlight
44
10
The ROSS VMC-1000 VersaMix is a 1000-gallon triple-shaft mixer available on a pivot-design single-post hydraulic lift.
Portable Air Particle Counter for Cleanrooms
October 02, 2020
Product Spotlight
44
10
Beckman Coulter Life Sciences announced that its MET ONE 3400+ portable air particle counter is now available for cleanroom compliance.
Compact Capillary Electrophoresis System
October 02, 2020
Product Spotlight
44
10
The Spectrum Compact CE System from Promega is a benchtop capillary electrophoresis (CE) instrument that allows users to perform sequencing and fragment analysis at the bench in laboratories of all sizes.