Newsletter | March 27, 2025

03.27.25 -- A Practical Guide To Defining Priority Data In MES

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Webinar: Development Strategies for Platform Devices

Navigating Regulatory Complexities: Formulation, Compliance, and Market Approval This webinar focuses on FDA regulations for platform technologies in drug-device combinations, like prefilled syringes and autoinjectors. It covers strategies for bridging formulation changes, leveraging existing data for submissions, and de-risking innovation. Key takeaways include optimizing regulatory strategies, ensuring compliance, and balancing speed-to-market with FDA expectations for successful approval. Click here to learn more.

INDUSTRY INSIGHTS

Formulation And Evaluation Of Enteric Coated Aspirin Capsules

Enteric polymer coatings play a crucial role in oral drug formulations, protecting the API from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location.

How To Select The Ideal HPAPI Manufacturing Partner

To ensure the safety of personnel throughout the production of HPAPIs, manufacturers must effectively utilize containment and well-designed equipment.

Transforming A Liquid Protein Solution Into A Solid Oral Dosage Form

Unlocking the potential of oral protein therapeutics requires innovative formulation and manufacturing strategies to overcome stability, absorption, and bioavailability challenges.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

Advancing API Development With Aseptic Manufacturing And Processing

Delve into the complexities of API sterilization and gain insight from best practices and the critical role of expertise in maintaining sterile production environments.

Characterizing The Effects Of Moisture On Pharmaceutical Materials

Moisture impacts pharmaceutical ingredients’ stability and efficacy, causing phase changes and hydrate formation. Discover an analyzer that enables humidity and temperature profiling for drug formulation.

Designing Shelf-Stable, Dry Powder Vaccines To Improve Global Access

Spray dry technology is being leveraged to create shelf-stable, dry-powder vaccines to treat and prevent the spread of tuberculosis which could significantly improve our global response to disease.

Technology Transfer Strategies: Fill-Finish Automation And Robotics

Establishing early and clear tech transfer strategies is a key component of a holistic approach to drug development. Explore the role that capable fill-finish solutions play in this process.

The Track And Trace Guide: Building An Effective Program

Review the purpose, technology, and functionality of track and trace in the pharmaceutical manufacturing and production process.

Spray Drying For Improved Solubility

Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.

Supporting The Unique Needs Of Your Sterile Injectable

Leveraging the experience and specialized technology of a reliable CDMO partner is essential to ensure your sterile injectable therapeutic's safety and quality while delivering at speed.

Audit Preparedness: Using Digital Validation To Be Ready For Anything

Uncover how to prepare for an audit, from preparation and documentation to streamlined processes and digital validation to ensure compliance and successful inspections in regulated industries

Effective Procurement Strategies For Labeling Systems

What is actually behind the procurement of a pharmaceutical labeling machine and how does the process work? You can find out here what the path to your pharmaceutical labeling machine looks like.

Speed To Market – API Large-Scale Commercial Manufacturing

See how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

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Webinar: Pharmaceutical Labeling: How To Optimize Labeling In A Pharmaceutical Environment

Accurate and readable pharmaceutical labeling ensures patient safety, effective medication use, and regulatory compliance. In this webinar, you’ll learn how factors like speed, printing methods, and inspection criteria influence the choice of labeling machinery. HERMA, with 40,000+ global installations, specializes in vial, bottle, syringe, autoinjector, carton, and tamper-evident labeling, offering solutions to meet space constraints and automation needs. Click here to learn more.

FEATURED EDITORIAL

A Practical Guide To Defining Priority Data In MES

The adoption of automation and digital technology has become imperative. Manufacturing execution systems (MES) play a crucial role in pharma/biotech, but MES platforms face the challenge of identifying the critical data that should be prioritized for supporting effective operations.

SOLUTIONS

Purpose-Built For The Modern Quality Management Ecosystem

Flexible Manufacturing Solutions To Meet Evolving Industry Needs

Blister Packaging Printing System

Single-Use Active Air Microbial Monitor Guidance

How To Easily And Quickly Monitor Cleanrooms

Tackling The Toughest Small Molecule Challenges

High Speed In-Line HVLD For Pre-Filled Syringes

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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.

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