05.19.26 -- How Generic Pharma Manufacturers Can Rebuild Margins Inside The Four Walls

Stop chasing missed pull windows caused by disconnected spreadsheets. Centralized, automated systems ensure regulatory compliance and keep your critical stability studies on track today.

Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

Here, we demonstrate how adding small amounts of mesoporous silica to Cholesterol before jet milling can enhance processing efficiency, boost yield, and improve micronization performance.

Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.

Explore the rising challenges of recall management in life sciences. This six-part series offers expert insights and unveils a groundbreaking solution set to transform how companies manage recalls.

Advances in synthesis, enzymatic ligation, and purification are reshaping oligonucleotide manufacturing, improving scalability, sustainability, and complexity from research to production.

CMMS and EAM go-lives in GMP environments hinge on more than timing. See how big-bang, phased, compliance-first, and patchwork approaches shift validation effort, audit risk, and operational strain.

Modern therapies demand higher sterility assurance and flexible operations. Find out how advanced contamination control, barrier systems, and automation strengthen quality and support faster delivery.

Environmental monitoring (EM) is essential, but it’s only part of the picture. Examine why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.

Delve into how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.

What is head pressure in your hopper, and how does it relate to tablet press performance? Take a deeper look into these questions and learn strategies to achieve a steady flow.

Integrate a strategic intellectual property approach early in drug development to streamline research, uncover opportunities, and maximize the return on your investment.

Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

Gain insight into three tools that facilitate a successful journey from candidate compound to clinical triumph: solid form screening, PBPK modeling, and AI-enabled route scouting.

Standardized, continuously optimized facility design enables scalable and reliable biomanufacturing that improves quality, accelerates timelines, and ensures consistent performance across sites.