Pharmaceutical Technology
March 02, 2020
Regulatory Watch
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States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.
March 02, 2020
From the Editor
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Emergency action to protect patients and the drug supply may have long-term implications.
March 02, 2020
Ask the Expert
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No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
March 02, 2020
Product Spotlight
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The Double Planetary Mixer from Ross is scalable through 1000-gallon production models and is offered in a sanitary turnkey configuration that features a stainless-steel workbench for the mixer and discharge system.
March 02, 2020
Product Spotlight
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The SAS Tri-Clover Isolator Head from Cherwell Laboratories allows for precise and flexible monitoring of isolator cabinets and filling lines in cleanroom, isolator, and other controlled areas.
March 02, 2020
Product Spotlight
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Thermo Fisher Scientific launched the ALPS 5000 Plate Sealer to simplify the plate sealing process and provide enhanced dependability and productivity for stand-alone and integrated robotic projects.
March 02, 2020
Product Spotlight
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Readco Kurimoto introduced a continuous processor with a double clamshell barrel design that provides full access to the paddle and screw assembly to enable thorough cleaning and inspection processes while allowing for easy adjustments to the configuration.
March 02, 2020
Manufacturing
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Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.
March 02, 2020
Analytics
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As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.
March 02, 2020
Development
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Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.
March 02, 2020
Development
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A brief overview of three notable cases of adverse drug reactions.
March 02, 2020
Development
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A study finds a potential risk of persistent visual side-effects in male patients taking the highest recommended dose of sildenafil.
March 02, 2020
From the Editor
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Despite increasing R&D budgets by bio/pharma companies, returns on this investment are reducing and the cost of bringing an asset to market is increasing.
March 02, 2020
Regulatory Watch
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EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.
March 02, 2020
Analytics
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Metrology has the potential to not only prevent harm to patients but also to support innovative therapeutic options.
March 02, 2020
Quality/Regulations
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While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.
March 02, 2020
Manufacturing
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Tackling process development early on can better optimize manufacturing processes for emerging therapies.
March 02, 2020
Cover Story: Cell and Gene Therapies
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The growing interest in developing cell and gene therapies has prompted industry investment to grow manufacturing capacity.
March 02, 2020
Cover Story: Cell and Gene Therapies
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The last year has seen intense investment activity into raising cell and gene therapy manufacturing capacity.
March 02, 2020
Operations
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Energy and water waste can be improved with new technologies, and sustainability can be considered in the design of new facilities.
March 02, 2020
Outsourcing
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Can investing in early formulation studies drive a new therapy successfully across the commercialization finish line?
March 02, 2020
Development
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Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.
March 02, 2020
Peer-Reviewed Research
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The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.
March 02, 2020
Issue PDF
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Click the title above to open the Pharmaceutical Technology March 2020 issue in an interactive PDF format.