Newsletter | June 17, 2019

06.17.19 -- Essential Considerations For Better Microbial Data Deviation Investigations

Featured Editorial
Essential Points To Consider For Better Microbial Data Deviation Investigations
By Paula Peacos, ValSource, Inc.

Microbial data deviation investigations are notoriously difficult to perform. They are time-consuming and labor intensive. Determining the definitive root cause is often challenging. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial and often scanty.

Is Continuous Manufacturing Right For Your Product?
By Jerry Martin

Developing a continuous manufacturing (CM) process for a new drug or implementing CM for an existing batch process demands significant time, effort, and money. Adapting any manufacturing process to CM requires in-depth chemical and mechanical engineering understanding as well as the right technologies.

Industry Insights
3 Steps To Determine Need For Performing A Shipping Lane Qualification
Article | By Travis Hudson, Singota Solutions

Learn how to perform various risk assessments to adequately determine the level of control required to ensure the safe transport of products throughout the pharmaceutical supply chain.

Why Cell-Based Assay Is The Preferred Method To Support Potency Analysis For Biologics
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.

Digital Manufacturing Of Biologics
White Paper | GE Healthcare Life Sciences

In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

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.

Anticipating The Formulation Challenges Of Complex Molecules
Article | Thermo Fisher Scientific

Due to the increasing complexity of today’s API molecules formulation problems are arising with greater frequency, delaying development and burdening developers with unanticipated and heavy costs.

Single-Use Systems For Storing And Shipping Frozen Drug Materials
Article | CPC

The logistics of decoupling drug substance manufacturing from final drug product formulation is now possible using integrated single-use freeze-thaw assemblies that incorporate reliable components.

The Relationship Between The Chemical Nature Of Bacterial Endotoxins And Their Toxicity And Immunogenicity
Article | FUJIFILM Wako Chemicals U.S.A. Corp.

The diseases related to Gram-negative bacteria affect humans and animals and, in many cases, are difficult to treat, which is why it is important to have effective and bacteria-specific antibiotics.

Which Test Is Appropriate For Container Closure Integrity?
Article | Parenteral Drug Association (PDA)

Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.

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