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Pharmaceutical Technology-05-02-2021
Pharmaceutical Technology
Injecting Innovation into Drug Packaging
May 03, 2021
Cover Story
45
5
Complex formulations, personalized medicines, COVID-19 therapies, and sustainability goals are driving innovations in drug packaging.
Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 1–Content Uniformity
May 03, 2021
Peer-Reviewed
45
5
This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data.
QbD Helps Evaluate Excipient Variability
May 03, 2021
Development
45
5
Applying a QbD approach helps address excipient variability and other quality features.
Overcoming Vaccine Development Challenges
May 03, 2021
Development
45
5
Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.
Combining Multiparticulates and 3DP for Patient-Centric Dosage Forms
May 03, 2021
Manufacturing
45
5
Aprecia and Glatt investigate manufacturing technologies to widen the formulation design space for oral delivery.
Beyond Lyophilization
May 03, 2021
Manufacturing
45
5
Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
May 03, 2021
Manufacturing
45
5
Despite the COVID-19 pandemic, the industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.
Responding to FDA CAPA Requests
May 02, 2021
Quality/Regulations
45
5
Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.
Evolving Analytical Technology Unravels Protein Characteristics
May 02, 2021
Analytics
45
5
Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.
FDA and Industry Move to Renew New Drug User Fee Programs
May 02, 2021
Regulatory Watch
45
5
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
Moving Into the Next Phase
May 02, 2021
From The Editor
45
5
As face masks start to come off, bio/pharma’s COVID-19 battle goes on.
Acknowledging Bio/Pharma Innovation
May 02, 2021
From The Editor
45
5
The world of bio/pharma has been celebrating its achievements across a variety of categories in the latest rounds of awards.
Computerized System Descriptions–How Hard Can It Be?
May 02, 2021
Ask the Expert
45
5
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.
Single-Use Biomass Sensor
May 02, 2021
Product Spotlight
45
5
Aber Instruments launched its new Futura neotf single-use biomass sensor for process fingerprinting for on-line monitoring and control of cell culture.
Automatic Balance for Powder Weighing
May 02, 2021
Product Spotlight
45
5
The XPR Automatic Balance by Mettler Toledo works to reduce exposure risk and ensure precision and throughput while powder weighing in laboratories.
Inline High Shear Mixers from ROSS
May 02, 2021
Product Spotlight
45
5
Inline High Shear Mixers from ROSS are suitable for a wide range of dispersion, emulsification, and homogenization requirements
Bag Dump Module for Bulk Solid Equipment
May 02, 2021
Product Spotlight
45
5
Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are dumped manually.