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Pharmaceutical Technology-07-02-2020
Pharmaceutical Technology
Performing Remote Audits During the Pandemic
July 02, 2020
Ask the Expert
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7
It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.
Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy Facilities
July 02, 2020
Operations
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7
Manufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.
Demand for Custom Dosage Forms Fuels Innovation
July 02, 2020
Cover Story: Drug Delivery
44
7
Demand for custom drug delivery solutions is increasing and bringing forth an exciting period of valuable, innovative development opportunities.
Learning Regulatory Lessons in Times of a Crisis
July 02, 2020
Quality/Regulations
44
7
There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.
Business on Hold? EMA’s Full Recovery in Question
July 02, 2020
Regulatory Watch
44
7
EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.
Taking a Controlled Approach
July 02, 2020
Development
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7
Controlled-release formulations offer numerous advantages for developers and patients, and this market is expected to continue to experience growth in the near future.
Unprecedented Times in Vaccines
July 02, 2020
From the Editor
44
7
COVID-19 vaccines are being developed rapidly, giving rise to a reinvigoration of the sector.
No Business, Like Brexit Business
July 02, 2020
Operations
44
7
As Brexit talks intensify, bio/pharma companies from both the UK and EU need to consider and aim to prepare for all scenarios.
Innovating Continuous Twin-Screw Granulation with Foam Delivery
July 02, 2020
Manufacturing
44
7
Using a specific addition method to wet the powder bed in twin-screw granulation using a foam binder improves robustness for continuous solid-dosage drug product manufacturing.
Can RNA Simplify Gene Therapy Development?
July 02, 2020
Development
44
7
RNA is easier to manipulate than DNA but challenging to deliver to the right cells.
Navigating Uncharted Waters
July 02, 2020
From the Editor
44
7
FDA Commissioner Hahn commits to a science-based review and approval process.
Contractors Balance Increased Demand During COVID-19
July 02, 2020
Outsourcing
44
7
The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.
Triple Quadrupole Mass Spectrometer
July 02, 2020
Product Spotlight
44
7
The LCMS-8060NX from Shimadzu is a triple quadrupole mass spectrometer that works to enhance method development and routine analysis.
Pump Tubing System
July 02, 2020
Product Spotlight
44
7
AdvantaPure’s GORE STA-PURE Pump Tubing systems can now overmold into any manifold tubing assembly as its pump element.
Double Planetary Mixer
July 02, 2020
Product Spotlight
44
7
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.
Settle Plate Stand for Cleanrooms
July 02, 2020
Product Spotlight
44
7
Cherwell Laboratories expanded its line of stainless-steel prepared media accessories for cleanroom monitoring programs with its new floor standing settle plate stand.
Solving Pharma’s Quality Unit Identity Crisis
July 02, 2020
Quality/Regulations
44
7
483s and Warning Letters Point to Inadequate Quality Oversight
Using Industry 4.0 to Optimize Oral Solid Dosage Form Manufacturing
July 02, 2020
Manufacturing
44
7
Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
Qualification of a Swab Sampling Procedure for Cleaning Validation
July 02, 2020
Peer-Review Research
44
7
The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
Pharmaceutical Technology North America, July 2020 (PDF)
July 02, 2020
Issue PDF
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7
Click the title above to open the Pharmaceutical Technology July 2020 issue in an interactive PDF format.
Pandemic Spurs Efforts to Boost Pharma Manufacturing in US
July 01, 2020
Regulatory Watch
44
7
FDA can better monitor quality production of domestic versus foreign firms.
Succeeding With OOS and Root-Cause Investigations
July 01, 2020
Quality/Regulations
44
7
Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.