Newsletter | September 9, 2019

09.09.19 -- What's A Cure Worth? ICER's Value Assessment

 
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  Maximize technology. Minimize cost.
 

The goal is to use as few steps as possible to reliably manufacturing a safe, effective, high-quality drug at a price point that makes sense. Check out this article for a deeper look at how to streamline operations to maximize utilization and reduce waste without sacrificing quality.

Read article: Achieving Operational Efficiency In Today's Fragmented Market

Featured Editorial
Is Your Personnel Hygiene Plan Up To Date?
 
By Mark Durivage, Quality Systems Compliance LLC

Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

What’s A Cure Worth? ICER's Value Assessment For Curative Therapies
By Yulia Privolnev, manager, global market access, Decision Resources Group (DRG)

The Institute for Clinical and Economic Review (ICER) recently conducted a study of value assessment methods considered for “cures” or “potential cures” and solicited input from international HTA bodies. The research will form the basis of a value framework that will be applied in the assessment of potential cures and other treatments that qualify as what ICER refers to as “single or short-term transformative therapies.”

Industry Insights
Solutions To Today’s Biomanufacturing Challenges
Article | By John Ward, Thermo Fisher Scientific

With more complex molecules in development, changing capacity needs, uncertain forecasts, and increased competition, the market demands flexibility and innovative approaches to today’s challenges.

Cell-Based Assay: The Preferred Method Of Biologics Potency Analysis
Article | By Aryo Nikopour and Ming Li, Ph.D., Nitto Avecia Pharma Services

A powerful choice: selecting potency assays for biologics. Will it be animal models, cells, or chemical assays? The decision can make or break product success.

A Holistic Approach To The Prevention Of Mycoplasma Contamination
White Paper | By Guy Matthews, Parker Bioscience

A combination of strategies to prevent contamination and advanced technologies can optimize performance and mitigate the risks from mycoplasma to your product and the patients it serves.

Purification Of Antibody Fragments And Single Domain Antibodies
White Paper | By Gerald Platteau, et al., JSR Life Sciences

The wide range of antibody fragment variants for which Amsphere A3 can be used as a capture resin is described, together with insight to the related binding mechanisms obtained via X-ray crystallography.

The Challenges Of Biopharmaceutical Quality
Q&A | Samsung BioLogics

More than ever, the quality functions in biopharma manufacturing are under pressure. That pressure is unlikely to be relieved any time soon due to a global market rife with complex quality standards.

Guidelines To Bring Your Biologic To Market: Are You Prepared?
White Paper | GE Healthcare Life Sciences

Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore these questions from a biopharma process development and manufacturing perspective.

Consistency And Repeatability Through Accurate Measurements
White Paper | Emerson

This paper demonstrates the importance of precision and repeatability, and describes how reliable, accurate instrumentation allows automation to support quality and productivity strategies such as the process analytical technology (PAT) initiative, continued process verification (CPV), and the ICH Q10 Pharmaceutical Quality System.

Efficient Purification Of A Recombinant Bacterial DyP-Type Peroxidase With A Hydrophobic Anion Exchange Resin
Poster | Bio-Rad Laboratories, Inc.

DyP (dye-decolorizing peroxidase) -type peroxidases have many potential uses in a variety of biotechnology applications. Here we show polish purification of bacterially expressed DyPs with a hydrophobic anion exchange — mixed mode resin — Nuvia aPrime 4A, to generate a >95 percent pure, functionally viable sample. The two-step workflow used in this purification is readily scalable for process production.

Master Cell Bank Production Of Liver Carcinoma Cells
Application Note | Thermo Fisher Scientific

This application note reports on the initial experience of Thermo Scientific Nunc High Density Cell Factory systems, which enable large-scale production of adherent cells.

Solutions
BIOSTAT STR: Scalable, Single-Use Bioreactor
Sartorius Stedim Biotech
Biotherapy Characterization: Cell-Based Assays
MilliporeSigma (Product Characterization)
Event
GE Healthcare Life Sciences Webinar: Smarter Development Of Chromatography Processes

September 24, 2019 | 11:00 AM EDT

Smart process development is a collection of approaches to make process development better and faster — providing the developers with tools to face the rapidly changing landscape. This webinar will review three fields that enable reduced timelines and improved outcomes of process development activities:

  • In-silico process development and data-driven decisions
  • Management of process variability through deeper process understanding
  • Use of high-throughput methodologies
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