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Pharmaceutical Technology-12-02-2019
Pharmaceutical Technology
Applying Lessons Learned from the Semiconductor Industry
December 02, 2019
Features
43
12
Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
Visualization Enhances Facility Design
December 02, 2019
Features
43
12
Visualization using virtual and mixed reality can aid with biopharma manufacturing facility design and training.
Bio Diol and IEX Columns
December 02, 2019
Product Spotlight
43
12
Shim-pack Bio Diol and IEX columns from Shimadzu Scientific Instruments improve the accuracy of the characterization of peptides, oligonucleotides, and other biopharmaceuticals.
Two-step Disposable Autoinjector
December 02, 2019
Product Spotlight
43
12
BD’s new Intevia 1mL two-step disposable autoinjector, a device that combines an autoinjector and a pre-fillable syringe into one system, has a two-step, push-on-skin activation feature that allows the effective and safe injection of drugs of different viscosities up to 35cP and different fill volumes up to 1mL.
Cube Plus for Pharmaceutical Manufacturing
December 02, 2019
Product Spotlight
43
12
Cube Plus by GiroNEX is an automated precision powder dispensing system for use in manufacturing powder-filled capsules and vials for early phase clinical trials and related drug development studies.
Triple Shaft Mixer with Powder Induction Manifold
December 02, 2019
Product Spotlight
43
12
The latest 600-gallon VersaMix Model VM-600 from Ross is qualified for high-speed subsurface powder induction with a proprietary Ross Solids/Liquid Injection Manifold (SLIM).
Fighting the Good Fight
December 02, 2019
From the Editor
43
12
Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.
Managing Excipient Interactions
December 02, 2019
API Synthesis and Manufacturing
43
12
The key is to ensure that excipients only interact with APIs via desired mechanisms.
‘Polling’ All the Way
December 02, 2019
From the Editor
43
12
As the UK heads to the polls for an unusual December general election, industry issues manifestos on medicines while Europe rejoices some movement … finally.
The Challenges for Regulators in the Digital Age
December 02, 2019
Regulatory Watch
43
12
Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.
Tackling Solubility in Drug Development
December 02, 2019
Features
43
12
Spray drying is a versatile and rapid technique that can provide companies with a suitable and scalable option to improve the solubility and bioavailability of drug products.
Meeting E&L Expectations
December 02, 2019
Features
43
12
As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.
Mitigating Risk to Secure the Drug Supply Chain
December 02, 2019
Cover Story
43
12
Communications and planning are crucial to recovering from supply, operations, and facility disruptions.
DOE Gains Ground in Biopharmaceutical Development
December 02, 2019
Features
43
12
As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.
Pharmaceutical Technology North America, December 2019 (PDF)
December 02, 2019
Issue PDF
43
12
Click the title above to open the Pharmaceutical Technology December 2019 issue in an interactive PDF format.
Quality Issues Offset Biomedical Advances
December 02, 2019
Regulatory Watch
43
12
Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.
Investigating Combination Product Failures
December 02, 2019
Ask the Expert
43
12
Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Approaches to Reduced Sampling and Testing for Starting Materials
December 02, 2019
Peer-Reviewed Research
43
12
This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.