Newsletter | July 27, 2026

07.27.26 -- Determining The Deviceability Of A Biologic

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Contamination control is evolving from a compliance checklist to a comprehensive, risk-based strategy for sterile drug manufacturing. Emerging USP draft chapters <1110> and <1114> align with EU GMP Annex 1 by emphasizing holistic contamination control, continuous verification, and scientific risk management. Although not yet official, these guidelines signal future regulatory expectations. Manufacturers that proactively strengthen contamination control strategies now will be better positioned to meet global requirements, protect product quality, and safeguard patient safety. Learn more

FEATURED EDITORIAL

Determining The Deviceability Of A Biologic

In this Live event segment, panelist Dominick DeGrazio discusses alignment of formulations with delivery devices. He points to key determiners including Target Product Profile (TPP), preferred dosage form, and using platform technologies versus assessing new device options.

The Hidden Operational Complexities Of Home Infusion

Home infusion can lower costs and improve access, but requires complex coordination, patient readiness, logistics, and monitoring to ensure safe and effective care.

INDUSTRY INSIGHTS

Advancing Drug Delivery At Home: Auto IV Cannulation

Autonomous IV therapy extends care beyond clinics, using imaging, precision control, and adaptive intelligence to improve vein access and enable safe treatment in more settings.

The Impact Of PEGs In The Small Molecule API Market

Explore how PEG selection shapes drug development success by understanding the benefits of expert CDMO partnerships that deliver custom solutions to enhance your small molecule program.

Annex 1 FAQs: How Is Behavior Changing As A Result Of EU GMP Annex 1?

EU GMP Annex 1 is driving meaningful changes in how teams behave inside cleanrooms. Understand what contamination awareness really means in practice and how to build a culture where speaking up is standard.

Future Of Pharma Packaging: Trends, Tech, And Patient Solutions

Explore how traditional and innovative pharmaceutical packaging formats improve patient adherence, support emerging therapies, and shape the future of drug delivery and treatment outcomes.

Device Design For Usability And Risk Reduction

Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.

Advancing Chronic Care Through GLP‑1 Innovation

GLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. See how patient needs, emerging tech, and regulations are reshaping chronic treatment.

SOLUTIONS

Oral Solid Dose Manufacturing From Development To Commercial Supply

A/L/P Assembly, Label And Packaging