Newsletter | June 10, 2025

06.10.25 -- 8 Ways To Drive Resilience In Oncology Drug Supply Chains

SPONSOR

Webinar: Cleanroom Conceptual Design Paradigm: Converting Spaces for GMP Operations Part 2

Join the AES Cleanroom Technology webinar to explore cleanroom conceptual design strategies for GMP operations. Learn how to convert alternative spaces into efficient production facilities while minimizing capital risk. Discover key principles for integrating process architecture and mechanical design and ensure compliance with cGMP and regulatory standards to enhance design functionality and environmental performance. Click here to learn more.

INDUSTRY INSIGHTS

Pressure Testing Your Readiness To Ensure GMP Batch #1 Success

Watch as an expert from an industry-leading CDMO provides insights into the crucial factors, challenges, and tech transfer methods needed to achieve right-first-time readiness and success.

Top 3 Mistakes Companies Make During Sterilization Validation

Sterilization validation is essential for product safety and compliance. Discover the top three mistakes companies make and learn practical strategies to avoid delays, non-compliance, and patient safety risks.

Continuous Manufacturing: An Evolving Technology For Drug Manufacturing

Explore the exciting developments in continuous manufacturing and learn how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.

Optimizing Cleaning And Disinfection As Part Of An Effective CCS

Examine the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.

Manufacturing Dry Powder Inhaled Formulations By Spray Drying

Kimberly Shepard, Ph.D., principal engineer in R&D, addresses the challenges associated with spray-drying late-stage lung cancer treatments, including proteins, peptides, and mAbs.

Technology Increases Flexibility And Safety In Aseptic Packaging

The aseptic blow-fill-seal (B/F/S) process has proven to be an ideal system for the creation of a wide variety of container shapes and sizes used for packaging sterile pharmaceutical liquids. 

Six Benefits A Biotech Should Expect From Their CDMO Program Team

Whether a biotech is emerging or established, a dedicated CDMO program team offers invaluable support through effective communication, technical and regulatory guidance, and adaptability.

Why Biotech Leaders Can't Afford Delays In Document Review

Document review is a hidden bottleneck in biopharma. Learn how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.

EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging

Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

Reducing Wastewater Incineration And Carbon Emissions

To reduce CO2 emissions and recycle higher volumes of solvent, drug manufacturers must engineer specialized approaches with flexible technologies that can be adapted.

Using An Adherent Platform To Scale-Up An Upstream Viral Vector Process

Gain insight into a helper-dependent adenovirus (HDAd) process that covers everything from bench-scale and optimization to tech transfer.

Form Fill And Seal Label Applicator For Drug Packaging

Uncover a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.

How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs

Find out how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.

SPONSOR

Webinar: Unlocking Data Integrity: Proven Strategies for GxP Compliance and Inspection Readiness

Join this IDBS webinar to explore practical strategies for achieving data integrity and GxP compliance. Learn how to build a robust data integrity framework, interpret regulatory expectations, and apply real-world insights to strengthen inspection readiness. Don’t miss this chance to enhance compliance, reduce risk, and protect product quality and patient safety—register now!

FEATURED EDITORIAL

8 Ways To Drive Resilience In Oncology Drug Supply Chains

From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

SOLUTIONS

Flexible Manufacturing Solutions, Services To Meet Evolving Industry Needs

Analytical Labs Particle Analysis

GMP Manufacturing

Compliance Program For EU Annex 1 Container Closure Requirements

Electronic Batch Records (EBR)

Patient-Centric Drug Delivery Device

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