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Featured Whitepaper: Vaisala
Risk-Assessment Strategy for Validating Environmental Monitoring Software
Sponsored By: Vaisala
In this pre-recorded 30-minute webcast, Vaisala’s Senior Regulatory Expert Paul Daniel, explains how to use risk-assessment tools to determine the validation requirements of computerized environmental-monitoring systems. This information will help to determine what to test and how to defend decisions during an audit. |
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Strategies for Successful Scale-Up Using Quality by Design
Sponsored By: DPT Laboratories
This executive summary will outline best practices for ensuring successful scale-up for manufacturing finished drug products by offering a systematic approach and technical case studies for implementing QbD through development to scale-up to commercial manufacture. |
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Pharmaceutical Development for ADCs
Authors: Lisa Hardwick and Wendy Saffell-Clemmer
Sponsored By: Baxter
Formulation, process, and analytical development for antibody-drug conjugates (ADCs) are complex. This white paper provides an overview of ADC structure and function; the development process; and lyo cycle optimization. |
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Devolatilization/Solvent Extraction via Twin Screw Extrusion
Author: Charlie Martin
Sponsored By: Leistritz
Devolatilization (DV) is the process by which various amounts of unreacted monomer, solvent, water, or other undesirable volatile contaminants are removed from a polymer melt. A twin-screw extruder (TSE) is a device that is commonly utilized to compound polymer formulations to facilitate specific end-product performance. Oftentimes, there are chase impurities in the polymeric system that need to be cleansed, sometimes as a result of tighter governmental or commercial standards, or due to the deleterious effects the residuals may have on final product properties. |
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Charles River Accugenix® MALDI-TOF Enhancements for Bacterial IDs Enable Improved Root Cause Analysis
Authors: C.E. Farrance, N. Patel, and A. Russell
Sponsored By: Charles River
Library coverage is often a topic of discussion for microbiologists wanting to know what the impact or relevancy of the Charles River Accugenix® library databases is on the identification of environmental, EM, or industrial microorganisms. As a contract laboratory service provider offering both sequencing (AccuGENX-ID®) and MALDI-TOF-based identifications (AccuPRO-ID® and the Axcess™ system), Charles River has the ability to compare reference libraries based on the microorganisms that we identify and analyze the reportable rates. |
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Product Manufactured for Its Intended End Use
Author: Dora Meissner
Sponsored By: BioSpectra
The goal of manufacturing a product for its intended end use provides an additional level of security to the product. |
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Three Steps to USP H2O Success
Author: Geoff Sheffrin
Sponsored By: OBK Technology Ltd.
USP water systems are highly specific in their requirements. To get there successfully is relatively easy, BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection cost effectively and with minimum maintenance. Here's how. |
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