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Pharm Tech
May 2019
Volume 43, No. 5
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|COVER STORY|

The Search for Bioprocess Productivity Improvement

Feliza Mirasol

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.
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|EXCIPIENT VARIABILITY|

Avoiding Excipient Variability

Cynthia A. Challener

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.
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|FORMULATION|

Role of Particle Morphology on Tablet Dissolution Rates

Renato BP Pinto, Anderson Albuquerque, Raphael Lopes

Particle morphology of magnesium stearate, added as an anti-caking agent in a high water soluble drug substance, has an influence on the dissolution rate of compressed tablets.
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|ASEPTIC MANUFACTURING|

Closed Systems for Aseptic Fill and Finish

Jennifer Markarian

Isolators, robotics, and other new technologies are ready to modernize aseptic pharmaceutical filling and packaging.
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|MANUFACTURING|

Single-Use in Downstream Chromatography: Benefit or Hindrance?

Feliza Mirasol

Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
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|PEER-REVIEWED RESEARCH|

Testing for Water in DMSO: Exploring Alternatives to Volumetric Karl Fischer Analysis

Andrew Johnson, Ashley Jones

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.
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|ANALYTICS|

Managing Biologic Equipment Cleaning

Feliza Mirasol

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.
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|PACKAGING|

Contract Packaging Grows

Hallie Forcinio

Contract packagers expand operations and services to accommodate growing need.
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|QUALITY CONTROL|

Using the Multiple Attribute Method for Process Development and Quality Control

Agnes Shanley

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.
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|OUTSOURCING|

Bioprocessing Facilities and FDA Inspection Problems

Ronald A. Rader

FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
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|FROM THE EDITOR|

Working for the Greater Good

Rita C. Peters

Pharma delivers a positive message with renewed efforts to eradicate malaria.
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|US REGULATORY WATCH|

FDA Faces Challenges After Gottlieb

Jill Wechsler

New agency leadership is pressed to promote innovation while addressing safety and quality issues.
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|ASK THE EXPERT|

The Auditor Vs. Inspector Issue

Siegfried Schmitt

We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.
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UPCOMING WEBCASTS

Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
Two Live Events: Tuesday, May 28, 2019 at 10am JST | 9pm EDT | 6pm PDT
Tuesday, May 28, 2019 at 5pm JST | 10am CEST
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Designing Amorphous Dispersion Formulations for Poorly Soluble Drugs
Thursday, May 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Technologies to De-Risk Biologic Candidates to Successfully Transition from Research to Clinic
Wednesday, May 22, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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ON DEMAND WEBCASTS

Geographic Advantage: Accelerating Clinical Supply in China and Global Trials
On Demand
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Sustainable Sourcing & Supply Chain Engagement in Pharma
On Demand
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Beating the Clock: Case Studies in Expediting Biologic Development
On Demand
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Patient-Focused Drug Design – A View from the R&D Front Lines
On Demand
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The Future of Highly Potent API Manufacturing – Lonza Perspective
On Demand
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Approaches to Analyze and Understand 1–100 µm Particles/Aggregates in Biotherapeutics
On Demand
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| Events |

BIO International Convention

June 3–6, 2019

2019 Process Validation Summit

June 12–13, 2019

Pharmaceutical-Nutraceutical Extrusion Seminar

June 12–13, 2019


more events
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