Newsletter | April 2, 2024

04.02.24 -- Process Development With "The End In Mind" For Startups


Webinar: Environmental Monitoring vs. Good Aseptic Technique

Join Particle Measuring Systems on April 23rd to learn what suitable environmental monitoring is required to meet the requirements of ISO and the regulatory bodies. We will look at manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems. Click here to learn more.


Process Development With “The End In Mind” For Startups

We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.


Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids

Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.

Real-Time Viable Particle Monitoring: How Does It Work? How Can It Help?

In aseptic manufacturing, laser induced fluorescence shows great potential to replace growth-based methods in certain manufacturing paradigms — highly automated, near-continuous processes.

AI Myths Vs. Reality In Quality

Hear from Mike Jovanis, VP of Vault Quality, as he sheds light on the common misconceptions of AI and emphasizes the reality of what you need to focus on to drive a quality transformation.

Embrace Quality Risk Management To Build A Strong Quality Culture

Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

How Product Traceability Serialization Systems Improve Consumer Safety

Tracking and tracing technologies were designed to fight against counterfeit and fake drugs. Learn how these technologies are experiencing a further leap forward due to the COVID-19 pandemic.

Making Sense Of Analytical Standards In Pharma QC

Reference materials are a critical component of the analytical testing workflow. Learn about metrological traceability, the hierarchy of reference materials, fit-for-purpose selection considerations, and more.

Top 3 Megatrends In OT Cybersecurity

Explore the megatrends that are shaping the future of operational technology (OT) cybersecurity and the strategic measures organizations can take to protect themselves against threats.

Identify And Mitigate Absorption Risks With PBPK Modeling

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

Secure Tech Transfers Of Biological Products In Sterile Manufacturing

Recognizing what it takes to complete technology transfers effectively and efficiently is crucial to selecting the best partner for your project and product needs.

A New Way To Perform mAb Capture

Combining high-productivity chromatography methods and SU affinity membranes delivers a viable alternative to the current packed bed Protein A capture techniques for intensified purification of mAbs.

A Technology Platform From Bertozzi Lab To Best-In-Class ADCs

Hear experts discuss the latest trends in antibody-drug conjugate (ADC) discovery and development and how next-generation pipelines are being shaped by payload and linker-chemistry innovations.

Investing In Capacity – API Commercial Manufacturing

A pharma company sought a CMO partner with commercial manufacturing capabilities and expertise as well as exemplary quality systems to find a cost-effective process to produce the API for a new drug.


Enhance Product Safety With A Non-Destructive Leak Testing System

A Gloveless Aseptic Filling System For Vials, Syringes, And Cartridges

Pinhole Inspector For Glass Vials And Ampoules

Custom Organ-Chips For 3D Gel Matrices And Direct Compound Dosing

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