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Pharmaceutical Technology-12-02-2020
Pharmaceutical Technology
Can Pharma Quality Go High Tech?
December 03, 2020
Cover Story
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The COVID-19 pandemic has pushed more pharmaceutical companies and regulators to use new technologies for remote quality audits and inspections.
HPAPI Complexity Prompts New Delivery Mechanisms
December 03, 2020
Development
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Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.
Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical Creams
December 03, 2020
Development
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Study results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
Modular Processes and Facilities Enable Flexible Vaccine Manufacturing
December 03, 2020
Manufacturing
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The COVID-19 pandemic has accelerated the need for modular designs to rapidly expand vaccine production capacity.
Nitrosamine Impurities in Medicinal Products
December 03, 2020
Quality/Regulations
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Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.
USP, COVID-19, and Plans for the Future
December 03, 2020
Quality/Regulations
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USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.
EDQM Combats COVID-19 and Makes Plans for Future
December 02, 2020
Quality/Regulations
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The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.
Complying with Lab Data Integrity Practices During COVID-19
December 02, 2020
Analytics
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Pharmaceutical laboratories must keep lab data integrity practices in mind in order to properly handle the effects of the COVID-19 pandemic.
E-beam Process Could Offset Sterilization Constraints
December 02, 2020
Operations
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Sterilization of primary packaging is important for vaccines.
Is the Packaging Supply Chain Ready?
December 02, 2020
Operations
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Packaging suppliers prepare to meet the demand unleashed by COVID-19 vaccines and treatments.
Manufacturing Materials for Clinical Trials
December 02, 2020
Outsourcing
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CDMOs strive for flexible, adaptable processes and fast tech transfer for manufacturing investigational drug products, including COVID-19 treatments and vaccines.
Pandemic Brings Major Changes to FDA and Drug Development in 2020
December 02, 2020
Regulatory Watch
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Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.
Inspecting GMP at a Distance
December 02, 2020
Regulatory Watch
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The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future.
Bio/Pharma, People, Perseverance, and Hope
December 02, 2020
From The Editor
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After a difficult year, bio/pharma science delivers promising results.
The COVID-19 Vaccine Blind Spot
December 02, 2020
From The Editor
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Transparency and open-dialogue are vital to sway the vaccine-hesitant community.
Impact of Pandemic on Permanent Procedures
December 02, 2020
Ask the Expert
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Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
ROSS Double Planetary Mixer
December 02, 2020
Product Spotlight
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The Double Planetary Mixer from ROSS is suitable for high-precision mixing, granulation, and vacuum drying all in one.
Integrated Seal Caps
December 02, 2020
Product Spotlight
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Gerresheimer now offers its Gx RTF syringes with SG ITC (Integrated Tip Cap) twist-off closure from Stevanato Group.
Granulation Equipment for High-Volume Batches
December 02, 2020
Product Spotlight
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ACG Group introduced the GT 1600 X.ONE, a line of integrated granulation equipment designed for high-volume batch production.
Remote Particle Counter
December 02, 2020
Product Spotlight
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The IsoAir Pro-E Remote Particle Counter by Particle Measuring Systems works to streamline cleanroom monitoring while complying with global regulations.
Intensifed Process Offers Cost-Effective Viral Vector Manufacturing
December 02, 2020
Manufacturing
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Pharmaceutical Technology spoke with Tania Pereira Chilima, Deputy CTO at Univercells Technologies about their technology and how it can be used in viral vector manufacturing, which is needed for production of some of the COVID-19 vaccine candidates.