Newsletter | March 17, 2020

03.17.20 -- Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk?

  Biologics API Contract Manufacturer Quality Benchmarking (5th Edition)

This report provides pharmaceutical companies and contract manufacturers with a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 22 performance attributes specific to outsourced drug substance manufacturing. In this Consumer Reports-style analysis, ISR presents data on 509 service encounters from 179 respondents who have been involved in outsourced biologics API projects in the past 18 months. More.

Featured Editorial
Business Continuity And The Coronavirus: Are Your Pharma Operations At Risk?
By Bikash Chatterjee, chief operating and science officer, Pharmatech Associates

As we face our latest pandemic threat, the need to have a well-defined and tested business continuity management plan in place cannot be overemphasized. Beyond state and national preparedness plans, organizations should be actively evaluating their continuity plans, especially when it comes to strategic contract service providers and partners, to ensure there is a reasonable mitigation plan in place. 

Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls And Best Practices
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)

This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.

Industry Insights
Advances In Temperature Calibration Procedures
White Paper | By Ehren Kiker, Endress+Hauser, Inc.

Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.

Choosing The Best Sterile Dosage Form For Your Phase 1 Needs
White Paper | By Tony Pidgeon, Thermo Fisher Scientific

When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.

An Introduction To Vacuum Decay Leak Testing
White Paper | By Oliver Stauffer, PTI Packaging and Inspection Systems

Vacuum decay as a test method provides significant savings by not wasting product for a leak test, and generates return on investment in under six months for many products.

Performance Validation, Verification, Monitoring, And Testing
White Paper | By Rob Rogers, Mettler-Toledo Product Inspection

This white paper gives guidance on the essential processes of validation, verification, and routine performance monitoring for in-line product inspection equipment in food-making facilities.

Procuring Pharma Equipment At The Speed Of Business
White Paper | By Adam Covitt, Federal Equipment Company

Since procuring equipment for your facility is a critical step for any manufacturing organization, it is in a manufacturer’s best interest to turn to an organization that can serve as a strategic procurement partner.

Expanding Sterile Crystallization Capabilities To Meet Rising Customer Demand
Article | By Frederic Baudry, FAREVA

Production of sterile powders requires specialized expertise and capabilities in sterile crystallization. Learn what your CDMO capabilities should be in order to deliver a quality product.

Risk Management And The Combination Product Testing Strategy
Poster | By D. Bantz, West Pharmaceutical Services, Inc.

Understanding combination product risks at the interfaces is critical. Components are often sourced at opposite ends of the globe and are proven to be robust due to investments in research, development, and testing. It is essential to have an equal and complete understanding of all components when they come together at the interfaces where the risks are hidden.

Serialization And Aggregation Requirements In Russia
Article | Wipotec-OCS

Russian president V. Putin signed Federal Law No. 488-FZ, which deals with the amendments to the Principles of State Regulation of Trading Activities in the Russian Federation.

Five Reasons To Consider Outsourcing Analytical Testing
White Paper | Micromeritics Instrument Corporation

Leveraging external experts for analytical input provides a cost-effective route to the latest instrumentation, robust and precise measurement, and reliable data interpretation. 

Medium Preparation For Single-Use Fermentation
Application Note | GE Healthcare Life Sciences

To overcome many of the challenges associated with stainless-steel vessels, single-use fermentors offer an increasingly viable alternative. 

The Criticality Of API CDMO Selection: Insights From A Client
Case Study | Thermo Fisher Scientific

Small and emerging companies face challenges related to limited funding and resources, such as technical expertise and capacity, making it imperative they find a competent partner to support them.

Customer Loyalty In Biologics Drug Product Manufacturing
Infographic | ISR Reports

In Q42018, ISR surveyed 138 sponsors who outsource drug substance manufacturing for biologics compounds to gain insight into their CMO loyalty. ISR computes customer loyalty as an index that consists of overall satisfaction, willingness to recommend, and likelihood to use the CMO again.

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