Newsletter | May 6, 2025

05.06.25 -- Pharmaceutical Sovereignty: The Resilience We Cannot Outsource

INDUSTRY INSIGHTS

Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance

Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, which aid in cleanroom qualification, environmental monitoring, and strategies.

An Introduction To High Voltage Leak Detection (HVLD) Technology

A majority of methods used to detect pinholes, cracks, and defective seals in containers are destructive. Learn about High Voltage Leak Detection (HVLD) and why it is free from these shortcomings.

Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

From Open Cleanrooms To Closed Systems – What Is Driving The Change?

Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.

CMC And Clinical Strategies For Developing Injectable, Oral Peptide Drugs

In this session, Chief Scientific Officer Dr. Andy Lewis delves into the key drivers shaping peptide drug development and explores innovative delivery options to enhance therapeutic outcomes.

Fundamentals For Bispecific Antibody-Based Cell Line Development

BsAbs’ dual specificity opens a wide range of applications. Understand why consistent production of structurally complex molecules that exhibit high yield and purity requires keen expertise and experience.

What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?

The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.

Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends

Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

Microbial Air Sampling: Physical And Biological Collection Efficiencies

GMP compliance requires monitoring microbial contamination levels in cleanrooms and clean spaces. It is important to know the role active air samplers play in this process and parameters for evaluating them.

Bispecific Antibody (BsAb) Development And Manufacture

Discover the impact that poor assembly and expression can have on downstream purification and formulation and how addressing these challenges at an early stage ensures cost-effective production.

The Golden Tool For Container Closure Integrity Testing

Uncover the power of headspace gas ingress in ensuring product quality. Dr. Derek Duncan, Director of Product Lines, reveals the golden tool for container closure integrity testing.

FEATURED EDITORIAL

Pharmaceutical Sovereignty: The Resilience We Cannot Outsource

Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration. 

SOLUTIONS

High Performance Thermogravimetric Analyzers

Flexible Manufacturing Solutions To Meet Evolving Industry Needs

PBPK Predictive Modeling Services

Nasal Spray Development And Manufacturing Services

Validation And Quality Management Software Platform

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