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Pharmaceutical Technology-10-02-2019
Pharmaceutical Technology
FT-IR Spectrometer
October 02, 2019
Product Spotlight
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The new Fourier-Transform Infrared (FT-IR) spectrometer from Protagen Protein Services is used for advanced structural characterization of protein-based biologics and monitoring of vibrational modes of the amide bonds within a protein while in its native state and formulation matrix.
Nexera Prep Series
October 02, 2019
Product Spotlight
43
10
The new Nexera Prep Series Preparative Purification Liquid Chromatograph by Shimadzu improves prep processes for extraction of functional and impurity components, purification of target compounds in the pharmaceutical, chemical, and food industries, and productivity via flexible scalability and preparative workflow.
Pharmaceutical Cleanroom Monitoring
October 02, 2019
Product Spotlight
43
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Airnet II Stainless Steel by Particle Measuring Systems (PMS) aids in cleanroom monitoring in high dust and moisture environments.
Multi-Shaft Mixers for High-Quality Gels and Creams
October 02, 2019
Product Spotlight
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VersaMix Multi-Shaft Mixers from Ross utilize a proprietary powder induction feature for charging of thickeners to produce high-quality gels, creams, and pastes.
Stability Testing for Small-Molecule Clinical Trial Materials
October 02, 2019
API Synthesis and Manufacturing
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Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.
Image Repair Must Get to the Root Cause
October 02, 2019
From the Editor
43
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Climbing out of a reputation hole starts with adopting a quality culture.
The Never-Ending Brexit?
October 02, 2019
From the Editor
43
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With no plausibly approvable deal on the table in the UK government at the moment, it is possible that Brexit could be extended even further.
Out with the Old and In with the New European Commission
October 02, 2019
Regulatory Watch
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A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.
Data Integrity Violations Draw Strong FDA Rebukes
October 02, 2019
Regulatory Watch
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Falsified documents and manipulated test results prompt warnings and investigations.
The Fundamentals of Dissolution Testing
October 02, 2019
Features
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In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
Overcoming Bioavailability ‘Roadblocks’ with LBDDS
October 02, 2019
Features
43
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Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.
The Demands of the Perfect Dose
October 02, 2019
Cover Story
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As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.
Getting in Touch with New Guidance on Topical Products
October 02, 2019
Features
43
10
Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.
ALCOA+ and Data Integrity
October 02, 2019
Ask the Expert
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Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Best Practices in Handling HPAPIs
October 02, 2019
Features
43
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Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.
New Technologies for Fill/Finish Streamline Operations
October 02, 2019
Features
43
10
Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.
Tracking Raw Materials in Biopharma Manufacturing
October 02, 2019
Features
43
10
Automated, electronic systems for raw materials tracking improve efficiency and prevent mistakes in biopharma manufacturing.
Distribution of Data: The Central Limit Theorem
October 02, 2019
Features
43
10
Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution.
Lessons from FDA 483s and cGMP Inspection Data
October 02, 2019
Features
43
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Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
Optimizing Manufacturing Based on the Storage Stability of Pegylated Products
October 02, 2019
Peer-Reviewed Research
43
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Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
Pharmaceutical Technology North America, October 2019 (PDF)
October 02, 2019
Issue PDF
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Click the title above to open the Pharmaceutical Technology October 2019 issue in an interactive PDF format.
Using Software in Process Validation
October 02, 2019
Features
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Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
Best Practices for Studying Stability in Biologics
September 01, 2019
Features
43
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Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.