Newsletter | April 3, 2025

04.03.25 -- The Potential Of AI In Managing Adverse Events For Small Molecule Drugs

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Webinar: Curing the Cost of Poor Quality: How Argon Medical Found the Remedy

Poor quality can cost a company 10-20% of its revenue. An electronic quality management system (eQMS) helps identify good and poor quality costs, allowing for better resource allocation to reduce waste and rework. Join experts from Argon Medical for insights on how an eQMS improves efficiency, cuts costs, and enhances customer satisfaction by streamlining reporting and training. Click here to learn more.

INDUSTRY INSIGHTS

Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP

Gain insights into the nuances of cleanroom conceptual design for GMP operations and learn how an integrated approach can ensure regulatory compliance, functionality, and environmental performance.

Identify Lead Solid Form Early To Reduce Timelines And Downstream Costs

Devoting early-phase resources for solid form understanding and screening during a drug’s development lifecycle is critical, as doing so can help save time and resources on the path to market.

Avoiding The Pitfalls Of PQR

Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

Using Advanced Technologies To Formulate Complex Molecules

In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.

FAQs On The Revised EU GMP Annex 1: Volume 1

The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

The Cost Savings Of Blow-Fill-Seal: More Than A Million Reasons To Switch

Despite the benefits of B/F/S over glass, some pharmaceutical companies refuse to make the switch. Examine how an investment in B/F/S may yield incredible long-term savings.

Improving API Solubility

Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.

Development To Large-Scale cGMP Production

For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

MSD Global Digital Validation Rollout

See how MSD digitized global validation processes achieved over 50% cycle time reduction, streamlined workflows, improved compliance, and enhanced remote collaboration during COVID-19.

The Use Of Cell Therapy Isolators To Reduce Batch Contamination

Advancements in Pharma 4.0 are driving the need for facility design solutions to deliver cost savings. Learn why integrating closed processes is an increasingly effective method for efficiency.

Pharma Custom Isolator For Sterile Lab Process

This project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.

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Whether you're breaking ground on a brand-new manufacturing facility or looking to upgrade an existing site, there are a dizzying number of considerations. Join Pharmaceutical Online Live on Wednesday, April 16th for a digital panel discussion on key factors in facility design, from construction sequencing to site validation. Registration is free thanks to the support of AES.

FEATURED EDITORIAL

AI's Promising Role In Adverse Event Management Of Small Molecule Drugs

Effective adverse event (AE) reporting is critical in ensuring patient safety. By fostering a proactive, technology-driven environment, pharma manufacturers can ensure swift, accurate tracking of adverse events while advancing patient safety and meeting compliance standards.

SOLUTIONS

AI-Enabled Route Scouting Service

Drug Product Development And Manufacturing Services

Cleaning Hormone Residues

The Leading Electronic Quality Management System (eQMS)

Computer Software Assurance And Computer System Validation

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