Newsletter | February 9, 2024

02.09.24 -- Driving Pharma/Biotech Capacity With Smart Manufacturing


Driving Pharma/Biotech Capacity With Smart Manufacturing

It's time for manufacturers to consider a new approach to capacity management, one that can not only resolve today’s challenges but also position the enterprise to drive innovation and resilience in the future. You can leverage a smart manufacturing approach in three vital ways.


Media And Feed Development: A Guide To Workflow Optimization

Gain insight into each development stage and explore best practices that will help achieve your project goals on time and within budget.

Quality Metrics: How To Add Value And Meet The FDA's Expectations

Establishing and utilizing quality metrics is essential for the pharma industry's future success. Learn how to identify meaningful metrics and appropriately measure quality to make better business decisions.

The Role Of PUPSIT In A Contamination Control Strategy

Here, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing-grade filtration in the control strategy, and talk about how this can change throughout the product life cycle.

Integrated Annex 1 Compliance

Learn about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.

Why Perform A Product D-Value Study?

Follow our discussion on non-heat-sensitive aqueous liquid product sterilization and the use of the overkill and bioburden/BI methods.

Using Robotics In The ATMP Space

With regulatory requirements and GMP recommendations trending toward less human interaction and more robotic automation, robotics is the way of the future for the ATMP industry.

Keep GxP Systems Current And Speed Up Time-To-Market

Examine why it is important to conduct software validation on any updated software and the role that automation can play in transforming your validation process.

Challenges Associated With In-Use Simulated Administration Of Biologics

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

Vaccines: An Overview Of This Lifesaving Innovation

Pharmaceutical manufacturing is highly regulated. Learn about what a vaccine is, how it works, the approval process, and how some vaccines can be fast tracked through the entire process.

Late-Stage Serialization Customization: A Key Differentiator For CDMOs

CMOs and CPOs currently face significant challenges, including strong competition, cost pressure, and more. Learn why being agile, flexible, and responsive is bound to pay off.

Rare Disease Clinical Endpoints: Ingenuity Meets Practicality

Unearth why defining meaningful biomarker endpoints has become more nuanced than just figuring out whether the protein of interest is being proliferated or silenced.


Lab Equipment And Testing Site Matrix

Solutions For Pharma Feeding Applications

European Center Of Excellence For Clinical Biologics

Remote Particle Sensors For Unparalleled Performance

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