Newsletter | January 14, 2020

01.14.20 -- The Shirokizawa Matrix: Determining The Level Of Effort, Formality, & Documentation In Cleaning Validation

Featured Editorial
The Shirokizawa Matrix: Determining The Level Of Effort, Formality, And Documentation In Cleaning Validation
By Andrew Walsh, Osamu Shirokizawa, et al.

This article shows how health-based exposure limits (HBEL)-based and process capability-based scales can be combined into a matrix that provides a clear visual guide for adjusting the level of effort, formality, and documentation for cleaning validation based on the level of risk.

Nickels And Dimes: What To Do When Your CDMO Charges You Unexpected Fees
By Barbara Berglund, COO, CMC Turnkey Solutions

In many cases, the business development and sales teams from your organization and the contract service provider work separately. What happens when the invoices have unexpected costs?

Industry Insights
Why Choose A Commercial HPAPI Manufacturer For Your Clinical Program?
White Paper | By George Hlass and David Bastie, FAREVA

Switching from an early-phase CDMO to a commercial-scale manufacturer for your highly potent active pharmaceutical ingredient (HPAPI) projects can be costly and lead to project delays.

Blow-Fill-Seal For Biologics: Breaking Through In Pharma Packaging
White Paper | By Bill Hartzel, Catalent, and Andy Goll, Weiler Engineering, Inc.

As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. 

Growing With A Flexible, Collaborative CDMO
Article | By Kim Berger and Paul Magreta, Grifols Recombinant Protein CDMO Services

Choosing a CDMO that is agile, innovative, and exhibits a willingness to invest in new equipment, infrastructure, and services will allow the innovator company and the CDMO to grow together.

Can You Trust A Machine For Downstream Bioprocess Buffer Preparation?
Article | By Enrique Carredano, GE Healthcare Life Sciences

Is automated buffer preparation a solution to the dilemma of balancing increased production capacity against limited footprint expansion alternatives?

Testing For Parenteral Packaging And Delivery Systems
Article | By Jennifer Riter, West Pharmaceutical Services, Inc.

There are many aspects to consider when developing a sound approach to performance testing to qualify packaging and delivery systems and combination products.

Transform With An Equipment Partner: Preparing For Serialization
Article | By Justin Kadis, Federal Equipment Company

Factors to consider as your organization works to conform to the serialization guidelines.

Delivering Flexible Fill-Finish Systems Without Complexity
Article | By Josh Russell, Automated Systems of Tacoma, Inc.

Next-generation drug products are more targeted and patient-specific by nature, causing batch sizes to be much smaller. This paradigm shift paves the way for more flexible manufacturing solutions.

Quality Metrics: How To Add Value And Meet The FDA's Expectations
Article | Ropack Pharma Solutions

Quality metrics have been widely used in the pharma industry to monitor quality systems and operational processes, and to promote continuous improvement initiatives in drug manufacturing.

Are The Components In Your Prefilled Syringes Compatible?
Article | Parenteral Drug Association (PDA)

While a prefilled syringe offers many advantages for biologic products, manufacturers must evaluate the potential impact of a prefilled syringe on product quality prior to selecting the final components.

Key Considerations When Purchasing An Ultralow Temperature Freezer
White Paper | NuAire, Inc.

Ultralow temperature (ULT) freezers have a typical service life between 12 and 15 years. When considering the replacement of a ULT freezer ten years old, or older, there are many variables to consider.

3 Development Principles For Advanced Biopharma Tubing: Part 1
White Paper | Meissner Filtration Products

The development principles in this paper ensure active risk mitigation and cleaner materials in single-use tubing applications.

Container Closure Integrity Testing Method Development
Webinar | Lighthouse Instruments

Recent regulatory revisions have put emphasis on robust method validation for container closure integrity testing (CCIT) methods. This webinar covers approaches that can be used for method development for CCIT in all phases of the product life cycle.

Microwave Digestion System: Multiwave GO
Anton Paar USA
Discover Our Freezing Capabilities: Celsius Product Lines
Sartorius Stedim Biotech
How One Split-Second Decision Made A Difference For Thousands Of Patients
Thermo Fisher Scientifc
Custom API Synthesis
Pfizer CentreOne Contract Manufacturing
Spray-Dried Dispersion Technology
Capsugel® | Lonza Pharma & Biotech
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