Pharmaceutical Technology July 2017

July 2017 | Volume 41, Issue 7
Pharmaceutical Technology July 2017 Issue
Focus
The more pharma science and technology change, the more business and policy concerns stay the same.
PharmTech's 40th Anniversary
As commercial manufacturing considers single-use materials, a look shows how industry moved to the technology.
How has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hold?
As pharma models changed during the past 40 years, contract manufacturing capacity and services evolved to meet demand.
Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.
A staggering percentage of people do not take their medication correctly, but pharmaceutical packaging aims to improve patient compliance using new technology to address reasons for non-adherence.
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
Oral solid-dosage and parenteral drug manufacturing equipment and systems have made great strides in safety and efficiency.
By Pharmaceutical Technology Editors
Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Patheon, shared his perspective of changes to solid-dosage pharmaceutical manufacturing.
Industry experts discuss how advances in analytical testing tools have helped address challenges in pharmaceutical analysis.
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.
Materials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.
Industrial-scale continuous API manufacturing may offer cost and safety benefits.
Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.
New ADC therapies must overcome manufacturing challenges to reach market.
From the Editor and Publisher
Pharmaceutical Technology marks 40 years covering the bio/pharma industry.
Expert Perspectives on Pharma Industry
By Pharmaceutical Technology Editors
Russell Madsen, president, The Williamsburg Group, and member of the Pharmaceutical Technology editorial advisory board, shares his thoughts on technology innovations and regulatory implications.
By Pharmaceutical Technology Editors
Biotech-based therapies and a move to single-use processes highlight recent industry changes.
By Pharmaceutical Technology Editors
Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.
By Pharmaceutical Technology Editors
ISPE measures impact of biotechnology and globalization on personalized medicine.
By Pharmaceutical Technology Editors
Drug costs, biosimilars, and cloud-based technologies will shape the pharmaceutical industry in the years to come.
By Pharmaceutical Technology Editors
Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.
By Pharmaceutical Technology Editors
Cheaper drugs are good for consumers, but cost restrictions limit drug company incentives to modernize facilities.
By Pharmaceutical Technology Editors
Regulations and business changes have altered Big Pharma’s place in the industry.
By Pharmaceutical Technology Editors
Advancements in cell culture and protein technology have opened the door for new therapies.
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Peer-Reviewed Research
Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.
Features
Polymers and surfactants impact stability and long-term performance.
FDA is working with manufacturers to encourage industry innovation.
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
From Pharmaceutical Technology Europe
Pharmaceutical Technology marks 40 years of publishing.
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.
Ask the Expert
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
Product Spotlight
By Pharmaceutical Technology Editors
Ribbon Blenders from Ross, Charles & Son can be used to mix powders, granules, and other dry solids.
By Pharmaceutical Technology Editors
Tablet coating from DISONA can handle batch sizes up to 3 kg.
By Pharmaceutical Technology Editors
A bathless dissolution tester from Distek operates without a water bath and associated maintenance.
By Pharmaceutical Technology Editors
The BIOSTAT STR single-use bioreactor family from Sartorius Stedim Biotech is based on a conventional stirred-tank design.
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