Newsletter | June 12, 2012

06.12.12 -- Micronization With Real-Time Particle Size Analysis

Pharmaceutical Online Newsletter

In This Issue:

Featured Articles

Micronization With Real-Time Particle Size Analysis
By Alon Vaisman and Afshin Nayeri, Malvern Instruments
Pharmaceutical manufacturers use milling to reduce the particle size of both active ingredients and excipients. The aim is to produce material that meets clinical efficacy targets — dissolution rate and bioavailability — and gives acceptable process performance.


California 2015 Serialization And e-Pedigree: Strategic Planning
By Michael Stewart, PharmTech, Inc.
What I want you to do is take a step back and instead of looking at this initiative as specifically a compliance project- a static, linear, regulatory challenge that has a beginning and end- I want you to view it as an opportunity. I want you to be possibility driven and accept the breadth and depth of choices out there.


Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers
By Ken Perrotta, Division Engineering Manager, Parker Hannifin Corporation
Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments, and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings.

Featured Downloads

White Paper: Tetracycline Antibiotics
Isoxazole functionalization technologies enable construction of tetracycline derivatives. Tetracycline antibiotics are effective against a broad spectrum of microorganisms including Grampositive bacteria and Gramnegative bacteria, as well as eukaryotic protozoan parasites.


ChargePoint® And ChargePoint® EXCEL Brochure
ChargePoint Technology is a market leader in the supply of containment valves and integrated material handling equipment for the pharmaceutical, chemical, food, and other process-based industries.


Securing The Lifeline: Mass Serialization Strategies For The Pharmaceutical Industry
Solving the problem earlier in the supply chain would be a more effective approach — containment at the source — before tragedy strikes and huge costs of recovery are incurred.


Sterile Drug Products Produced By Aseptic Processing: Current Good Manufacturing Practice
This guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing.


Datasheet: Xcelolab™ Powder Dispenser
The Xcelolab Powder Dispenser by Capsugel is specifically designed for accurate, closed loop, weight dispensing that is typically difficult.


Automated In Vivo Sampling: Innovative Technology To Significantly Advance Pre-Clinical Studies
The high cost of pharmaceutical development today, driven by constantly evolving pathologies and healthcare needs, pushes drug developers to pursue operational improvement while striving concurrently to raise quality and adhere to regulatory standards.

Industry News

Lilly CEO Calls For A Health Care Policy Environment That Promotes Medical Innovation
Recipharm Invests In Additional Cartridge Filling Machine For Injectable Solutions
Roche Submits TnT-hs Assay To FDA For Clearance On The Cobas Immunoassay And Elecsys Analyzers
Kansas City Region Launches Contract Research Initiative
Anderson Packaging And Brecon Pharmaceuticals To Form Full-Service Global Pharmaceutical Packaging Company
JHP Pharmaceuticals To Produce Clinical And Commercial Supply Of An Innovative Injectable
OICR Funds Fluorinov Pharma Inc. To Further Develop Its Novel Drug For The Treatment Of Blood Cancers
Complete Module For The Continuous Tablet Manufacturing Will Be Exhibited At Achema
Advaxis Completes Enrollment Of Cohort 2 In Phase 2 CIN 2/3 Study
View more headlines

Industry Webinar

Bio-G Webinar: Identifying and Mitigating Risk in Biopharmaceutical Supply Chains
June 27, 2012

In this 60-minute webinar and Q & A session, our two panelists, Professor Phil Kaminsky from the University of California at Berkeley and Rick Johnston, Ph.D. from Bio-G, will present their perspectives on supply chain risks and supply chain risk mitigation in our industry.

Please register (free, spaces strictly limited):
Americas: http://www.biomanufacturingleaders.org/webinar/riskus.html
Europe: http://www.biomanufacturingleaders.org/webinar/riskeu.html

Spotlight On DIA Annual Meeting

Q&A: Perspectives From The CRO Side Of The Table
Pfizer recently announced the strategic partnering with two CROs: ICON and PAREXEL. According to John Hubbard, Ph.D., senior VP and worldwide head of development operations for Pfizer, the goal of this collaboration is to increase R&D productivity. 

DIA Booth 2701

Strategic Partnering For Innovation
In Nice Insight's pharmaceutical and biotechnology outsourcing survey, 10% of respondants indicated that innovativeness was the most important attribute when selecting a CRO or CMO.

DIA Booth 1109

Incorporating Biomarker Research In A Real-World Setting
Using diagnostic tests to identify patients who would best benefit from particular therapies has long been the goal of many pharmaceutical R&D companies.

DIA Booth 1113

Brochure: CSC FirstDoc
FirstDoc, EMC’s preferred regulatory compliance solution for life sciences, is the proven document management and collaboration solution on Documentum that integrates with SharePoint.

DIA Booth 3231
Browse the download library

Featured Multimedia

ATMI's Richard Bhella Discusses Helium Integrity Testing
ATMI's Richard Bhella Discusses Helium Integrity Testing
Richard Bhella, ATMI global product manager, explains how ATMI is leveraging the use of single-use bag technology in their mixers, bioreactors, and storage systems.

Bulletin Board

Single-Use Tangential Flow Filtration Systems For Downstream Processing
Single-Use Tangential Flow Filtration Systems For Downstream Processing
June 26, 2012 | 10:00 AM EST

Tangential flow filtration (TFF) for protein purification and/or concentration must meet specified flow and pressure requirements to achieve scalable performance and high product recovery. A single-use TFF (SUTFF) system must be cost-effective and have a simple design format that can be easily adopted in a single-use manufacturing environment without compromising performance. Learn more.

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Featured Products And Services

High Speed Headspace Inspection Machine
High Speed Headspace Inspection Machine

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Lighthouse Instruments

Light Induced Fluorescence (LIF) Sensor
Light Induced Fluorescence (LIF) Sensor

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Natoli Engineering Company, Inc.

Liquid Dose Pharmaceutical Contract Packaging
Liquid Dose Pharmaceutical Contract Packaging

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Aphena Pharma Solutions

cGMP Stability And Release Testing: Large Molecules
cGMP Stability And Release Testing: Large Molecules

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Covance
DIA Booth BS1

Acsis ProducTrak™ SPDM Series
Acsis ProducTrak™ SPDM Series

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Acsis Inc.

HyClone Cell Culture Media And Supplements
HyClone Cell Culture Media And Supplements

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Thermo Scientific HyClone

TESCOM ER3000 Series
TESCOM ER3000 Series

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Emerson Process Management

Model 8M MultiTest System
Model 8M MultiTest System

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Pharmatron

AbsoluteProof  (Data Integrity Protection)
AbsoluteProof (Data Integrity Protection)

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Surety LLC

Pharmaceutical Metal Detector: INSIGHT PH
Pharmaceutical Metal Detector: INSIGHT PH

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Lock Inspection Systems

BioTrak Real-Time Viable Particle Counter
BioTrak Real-Time Viable Particle Counter

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TSI Incorporated

Sanitor Tank Washers
Sanitor Tank Washers

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Chemdet, Inc.