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Pharmaceutical Technology-11-02-2018
Pharmaceutical Technology
Guidelines on Integral Drug-Device Combinations
November 12, 2018
Regulatory Watch
42
11
Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
Multi-Purpose Biopharmaceutical Manufacturing Facilities Part II: Large-Scale Production
November 02, 2018
Features
42
11
A matrix of multi-functional cleanrooms can be adapted for launching products.
Design Space Characterization and Risk Assessment Through Mechanistic Modeling
November 02, 2018
Features
42
11
Mechanistic process and product modeling turns data into knowledge that can be extrapolated with known confidence for design space characterization and risk assessment.
Detachable AODD Pump
November 02, 2018
Product Spotlight
42
11
Wilden, part of PSG, a Dover company, released its new 6 mm (1/4”) Velocity Series air-operated double-diaphragm (AODD) pump.
Advanced Paddle Blender for Labs
November 02, 2018
Product Spotlight
42
11
Ross, Charles & Son’s Laboratory Paddle Blender offers advanced features for automated powder blending and liquid spraying operation with recipe management.
Custom Multi-Shaft Mixer
November 02, 2018
Product Spotlight
42
11
Ross, Charles & Son added a custom 150-gallon Triple Shaft Mixer, the Ross VersaMix Model VMC-150, with elaborate automation and safety functions.
Bioimaging Molecular Probes
November 02, 2018
Product Spotlight
42
11
Stream Bio’s Conjugated Polymer Nanoparticle products are a new generation of novel molecular bioimaging probes for diagnostic and therapeutic applications.
User Requirements Specifications–How Difficult Can It Be?
November 02, 2018
Ask the Expert
42
11
Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
Single-Use Bioprocessing Equipment Trends and Adoption by CMOs
November 02, 2018
Outsourcing Outlook
42
11
The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.
Innovations in Prefilled Syringes for Biologic Drugs
November 02, 2018
Features
42
11
As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.
Media Requirements for Different Cell Sources
November 02, 2018
Features
42
11
This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.
Uniformity of Dosage Units, Part 1: Acceptance Value
November 02, 2018
Peer-Reviewed Research
42
11
This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.
Building Capacity for Potent API Production
November 02, 2018
API Synthesis and Manufacturing
42
11
Demand for highly potent APIs continues to rise.
Innovation and Industry Strength Recognized at CPhI
November 02, 2018
From The Editor
42
11
Survey results and record attendance show positive signs for various bio/pharma regions.
Don’t Let CMC Oversights Derail Drug Development
November 02, 2018
Cover Story
42
11
Experts share best practices, and war stories, for a crucial but often underappreciated part of drug development.
FDA Provides More Clarity on DSCSA
November 02, 2018
Features
42
11
New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.
Pharmaceutical Technology North America, November 2018 (PDF)
November 02, 2018
Issue PDF
42
11
Click the title above to open the Pharmaceutical Technology November 2018 issue in an interactive PDF format.
Fasten Your Seatbelts …
November 01, 2018
From The Editor
42
11
… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.
FDA Promotes Complex Generics and Combination Products
October 19, 2018
Regulatory Watch
42
11
To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.