Newsletter | January 2, 2019

01.02.19 -- The "Unexpecteds" Leading Us Into 2019

From The Editor
The “Unexpecteds” Leading Us Into 2019
By Louis Garguilo, Chief Editor, Outsourced Pharma

What industry trends, developments or outcomes did not shape up as you had expected at the start of 2018? Here are replies to this question from the Outsourced Pharma Editorial Advisory Board, starting with an insightful list from Darren Dasburg, VP, Head Learning and Development, Global Operations, AstraZeneca. Considering what didn’t work out should help us focus in 2019.

Featured Editorial
Assessing The Impact Of New Equipment On Your CDMO’s GMP Operations
By Greg Weilersbacher, Eastlake Quality Consulting

Everyone is fascinated by new equipment, and the excitement is not limited to engineers and manufacturing technicians. To a CDMO, new equipment often translates to additional service offerings and higher-volume productions the company can use for fresh marketing content to attract new clients and return business from existing customers. To the sponsor, the CDMO’s new equipment could mean their next production may be able to start sooner than expected, or it might allow them to continue working with their existing CDMO rather than looking to the competition for the technology their product needs.

Advanced Auditing Strategies To Detect Data Integrity Risks
By Joy McElroy, Maynard Consulting Company

Data integrity is essential in the pharma, biologics, and medical device manufacturing industries. Not only is complete, accurate, and reliable data necessary to assure drug safety and quality, the growing reliance on increasingly sophisticated digital systems means that issues relating to data integrity are increasingly complex.

Industry Insights
Industry 4.0 Connects Machines And Data
Article | By Dr. Dirk Voelkel, GE Healthcare Life Sciences

By applying remote monitoring solutions, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers improved process reliability and product quality through unlimited possibilities of connecting machines and data.

How To Use QbD Software To Improve An Existing Identification Method
Article | Pfizer CentreOne Contract Manufacturing

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.

The Supply Chain Executive’s Perspective On Single-Supplier CDMOs
Q&A | Patheon

A single vendor offers access to a network of experts who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. 

Supporting Expansion Of Human Mesenchymal Stem Cells Using Thermo Scientific Nunc Cell Factory Systems
Poster | Thermo Fisher Scientific

Comparison of small-scale and larger-scale cultureware in supporting growth of multipotent human mesenchymal stem cells (hMSC).

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