Newsletter | March 3, 2020

03.03.20 -- Applying The Johari Window To Manage Pharmaceutical Supply Chain Risk

Featured Editorial
Applying The Johari Window To Manage Pharmaceutical Supply Chain Risk
By Jim Morris, NSF Health Sciences Pharma Biotech

The recalls of generic versions of the drug valsartan and related products losartan and irbesartan due to high levels of nitrosamine impurities have once again put the spotlight on sourcing strategies and the globalization of the pharmaceutical supply chain. Learn how the Johari Window model can help minimize risk and shrink the unknown risks inherent in any complex manufacturing supply chain.

Experimental Methods For Microorganism Challenges On Online Water Bioburden Analyzers
By Cynthia Martindale (Applied Rapid Microbiology Specialists, Ltd.), Scott Hooper (Merck), Miriam Guest (AstraZeneca), Hans-Joachin Anders (Novartis), Ulrich Georg Zuber (Roche), and Mike Russ (Genetech)

Implementing online water bioburden analyzer (OWBA) technology often includes laboratory microorganism challenge testing to verify that the instrument is suitable for its intended use. This requires the end user to select microorganisms for testing and successfully create quantifiable suspensions of these microorganisms for OWBA analysis. While this would seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.

Industry Insights
Is Your Partner Prepared For Your Scale-Up Challenges?
White Paper | By Devan Patel, Pharmaceutics International

Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, therefore it is critical you find a partner that can help you overcome the challenges.

Top 5 Events That Can Impact Your Clinical Supply Chain
Article | By Sylvia Tsengouras, Thermo Fisher Scientific

Review practical solutions for “small changes” in the clinical supply chain that can wreak havoc if not planned for in advance.

Pharmaceutical Oral, Injectable, And Semi-Solid Formulating
Article | By Justin Hardwick, Micromeritics Instrument Corporation

In pharmaceutical formulating the elements are often not fully compatible and must be mixed following a strict procedure to obtain a stable and durable structure. This task is even more challenging when formulating with natural ingredients. This article outlines the crucial steps to be considered for a full and complete characterization of your formula.

Tackling Powder Flow Problems By Choosing The Right Equipment
Article | By Matt Hicks, Federal Equipment Company

Identifying the source of product flow problems and correcting them with the right piece of equipment will result in more efficient and quality manufacturing.

Quality Assurance And Your CDMO
Article | By Chantale G. Robles, Grifols Recombinant Protein CDMO Services

The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

A Proven, Cost-Effective, Single-Use Powder Transfer Solution
Application Note | By Scott Patterson, ILC Dover

Single-use transfer technology has been used in biopharma manufacturing for years. However, upstream powder-handling processes haven’t been improved upon. Now, the industry is seeing a need for better ways to bring powders to the hydration process and begin upstream biologic manufacturing.

Purifying Plasmid DNA Using A Modern Chromatography Resin
Case Study | By Janice Charlesworth, Tony Hitchcock, Hazel Tharia, Henrik Ihre, and Åsa Hagner McWhirter, GE Healthcare Life Sciences

Through an industry collaboration, Cobra and GE were able to combine their expertise and experience and create a solution to meet the rising demand for high-quality plasmid DNA.

Mini-Spray Dryer Encloser Solution For Pharmaceutical Application
Case Study | Flow Sciences Inc.

A client required the design and build of an enclosure that could house the Buchi B-290 Mini-Spray Dryer during process. See how this designer/manufacturer was able to provide a solution that could offer containment down to less than one microgram per cubic meter.

Vacuum Conveying For Tableting Operations
Application Note | Coperion & Coperion K-Tron

The use of either dense-phase or dilute-phase vacuum transfer can be applied to tableting operations, such as the loading of blenders, sifters, mills, capsule fillers, tablet presses, and even tablet and capsule handling, without damage to the finished product.

Automated Foam Control In HyPerforma Single-Use Bioreactors Using A Single-Use Foam Probe
Poster | Thermo Fisher Scientific Bioproduction

The generation of foam is common in aerobic bioreactor systems. Foaming can cause a range of problems, including increased contamination risks through potential exhaust filter fouling, poor mass transfer, product/cell entrainment, increased shearing from bursting bubbles, and cell death. A foam probe for single-use bioreactor (S.U.B.) systems provides a robust solution for foam management.

An Overview Of Insights In Pharmaceutical Manufacturing, Clinical Research, And Technology
Webinar | ISR Reports

ISR conducted approximately two dozen individual pieces of market research for syndication in 2019. This webinar will summarize many of the important learnings from these projects and provide real, usable data for 2020 activities.

Protecting Oxygen-Sensitive Formulations Throughout The Product Life Cycle
Webinar | Lighthouse Instruments

Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Learn how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger and stability studies, for determining inherent primary packaging integrity, and for optimizing and qualifying inert gas purging system during filling.

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