BioPharm International-01-01-2018

BioPharm International

Selecting and Installing Peristaltic Pump Tubing

January 01, 2018

Features

31

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Proper selection and installation optimizes fluid system performance.

Additional Size for Quaternary Diaphragm Pumps

January 01, 2018

Product Spotlight

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The Wilden Quattroflow QF10k size pump from PSG, a Dover company, has been designed to fill the gap between the existing QF4400/5050 and QF20k pump sizes.

Single-Use Filling Assemblies for Aseptic Fill/Finish Applications

January 01, 2018

Product Spotlight

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Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.

Surveys Redefine “Ready”

January 01, 2018

Features

31

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Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the November 2018 US Drug Supply Chain Security Act serialization deadline.

Moving Toward Open Standard Specifications for Serialization Integration

January 01, 2018

Features

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A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.

Process Monitoring and Control Technologies Optimize Operations

January 01, 2018

Features

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New technological advancements seek to improve pharmaceutical process monitoring and control.

Bio/Pharma Serialization Nears a Tipping Point

January 01, 2018

Features

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Open standards based on GAMP and GS1 will soon be released and more companies are moving beyond basic compliance.

Science and Funding Inject Excitement into Biopharma

January 01, 2018

Cover Story

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Scientific advances and renewed investment may infuse biopharma for growth.

Milestones Mark Progress and Challenges

January 01, 2018

From the Editor

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BioPharm International will mark 30 years of biopharma industry progress and challenges in 2018.

FDA Drug Approvals Hit Record Levels in 2017

January 01, 2018

Features

31

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Gene therapies highlight FDA new drug approvals in 2017.

Evolving UF/DF Capabilities

January 01, 2018

Features

31

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Advances in TFF and single-use systems help advance UF/DF on the continuous processing path.

Stability Testing Ensures Proper Packaging for Drug Storage

January 01, 2018

Features

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Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.

Using Direct Transition Analysis in Chromatography

January 01, 2018

Peer-Reviewed Research

31

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The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

Drug Pricing and Quality Are Top Issues for 2018

January 01, 2018

Regulatory Beat

31

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Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.

Expansions in Cell Culture Facility Offerings

January 01, 2018

Features

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Recent investments show expansion activity in cell culture facilities.

What to Watch for in 2018

January 01, 2018

Perspectives on Outsourcing

31

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The industry will see an impact from financing, M&As, advanced therapies, generic drugs, and the retail market in 2018.

Meeting Data Integrity Requirements

January 01, 2018

Ask the Expert

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Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.

BioPharm International, January 2018 Issue (PDF)

January 01, 2018

Issue PDF

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Click the title above to open the BioPharm International January 2018 issue in an interactive PDF format.