Pharmaceutical Technology-04-02-2017
Pharmaceutical Technology
EU–US Mutual Recognition Agreement on GMP Inspections
April 03, 2017
Regulatory Watch
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Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.
Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough Therapies
April 02, 2017
Peer-Reviewed Research
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The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
Evaluating Progress in Analytical Quality by Design
April 02, 2017
Features
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The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
Staffing for China’s Rapidly Growing Biomanufacturing Industry
April 02, 2017
Outsourcing Outlook
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New study shows China biopharma companies face staffing shortages.
Making the Most of Internal Audits
April 02, 2017
Ask the Expert
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Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
FDA Quality Metrics Initiative Challenges Manufacturers
April 02, 2017
Regulatory Watch
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Industry fears limited benefits as FDA readies voluntary data tracking program.
Enabling Fluid Transfer for Cell Therapies: An Industry Challenge
April 02, 2017
Manufacturing
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The transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.
Multi-Functional Mixing System for Pastes, Creams, and Gels
April 02, 2017
Product Spotlight
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The VersaMix Multi-Shaft Mixer, from Ross, Charles & Son, is used to mix pastes, creams, and gel-type products.
Nanoparticle Deagglomeration Technology
April 02, 2017
Product Spotlight
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The Thinky PR-1 Nanoparticle Dispersion Machine from Intertronics is a desktop unit that can disperse carbon nanotubes (CNT), graphene, and other 2D nanomaterials within a closed container.
Cannabis Analyzer for Quantitative Determination of Cannabinoid Content
April 02, 2017
Product Spotlight
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The Cannabis Analyzer for Potency from Shimadzu Scientific Instruments (SSI) is a high-performance liquid chromatograph (HPLC) specifically for quantitative determination of cannabinoid content.
Mass Spectrometry System Standardizes Workflows
April 02, 2017
Product Spotlight
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The X500B QTOF System is the latest solution in SCIEX’s X-Series Quadrupole Time of Flight (QTOF) mass spectrometry (MS) platform.
Using Solar Energy for Process Heating
April 02, 2017
Features
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Renewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
Automating Bioprocesses
April 02, 2017
Features
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The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.
Designing Optimized Formulations
April 02, 2017
Cover Story
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Design of experiment plays a crucial role in the optimization process of formulation development.
Developing cannabis-based therapeutics
April 02, 2017
Cover Story
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David Fulper, PhD, director of technology support at Catalent, shares insights on the challenges and opportunities for cannabis-based therapeutics.
Key parameters to be optimized in the development and manufacturing of oral solid-dosage forms
April 02, 2017
Cover Story
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Anil Kane, executive director, Global Head of Formulation Sciences, Pharmaceutical Development Services at Patheon discusses key parameters in the development and manufacturing of oral solid-dosage forms.
Considerations when Quantifying Amorphous Contents in Milled Powders with Calorimetry
April 02, 2017
Features
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Interpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.
Critical Quality Attributes Challenge Biologics Development
April 02, 2017
Features
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The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Morphologically-Directed Raman Spectroscopy: Uncovering the Good, the Bad, and the Ugly in Drug Formulations
April 02, 2017
Features
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MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.
Redefining Excipients for Advanced Therapies
April 02, 2017
Features
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As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
PAT for Continuous API Manufacturing Progresses
April 02, 2017
API Synthesis and Manufacturing
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Advances in process analytical technology have been achieved, but significant challenges remain.
Now Arriving: CPhI North America
April 02, 2017
From The Editor
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Philadelphia plays host to CPhI North America on May 16-18, 2017.
Pharmaceutical Technology, April 2017 Issue (PDF)
April 02, 2017
Issue PDF
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Click the title above to open the Pharmaceutical Technology April 2017 issue in an interactive PDF format.