Newsletter | March 25, 2025

03.25.25 -- Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product

SPONSOR

Webinar: Minimizing your Risk in RNA-lipid Nanoparticle (LNP) Encapsulation and Drug Product Manufacturing Through a Holistic Approach

Join us on March 31st to discover how Lonza's platform-based strategy ensures stability, efficacy, and quality in LNP Drug Products with nucleic acid payloads. Learn about critical process challenges in encapsulation, filtration, and aseptic filling, and how to proactively mitigate risks for successful GMP batch manufacturing. Register now for expert insights! Click here to learn more.

INDUSTRY INSIGHTS

The Art And Science Of Pre-Picking Tablet Designs

Picking and sticking are the most common tablet defects that can reduce your product quality and performance. This makes perfecting the right pre-picking strategy essential to improving your processes.

Strategic CMC Planning Through A Phase-Appropriate Quality Approach

A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development phase. Watch how to apply such an approach to CMC planning.

The Digital Pharmaceutical Journey: 2025 And Beyond

By 2025 and beyond, AI, structured data, and real-world evidence will reshape the landscape, driving personalized medicine and more efficient processes. Here are eight key trends to be aware of.

Understanding The Importance Of Powder And Vapor Containment

Have you considered the safety of your work environment’s air? Across industries, employers are determining how to detect inhalation hazards and, if present, how to protect employees from them.

How To Value Automation With The Return On Invested Capital Model

Gain insight into the Return on Invested Capital (ROIC) advantages of an automated manufacturing facility and its correlation to the digital maturity of your operation.

The Critical Role Of Training In Cleanroom Cleaning And Disinfection

Learn why proper training is vital in cleanroom cleaning and disinfection and how to develop and maintain a successful training initiative.

Considerations When Outsourcing Your Packaging Operations

Discover how outsourcing this key aspect of bringing products to market can benefit your organization and overall supply chain optimization.

Oligonucleotide Therapeutics: Bridging From Research To Commercial

Examine the development and manufacturing expertise required to seamlessly transition from research to commercial stages to ensure smooth operation from early to late stage development.

Drug Product Process Characterization For Liquid And Lyophilized DP

Explore important initial steps to consider and implement during the process design phase which is a pre-requisite to a successful PPQ campaign and readiness for commercial manufacturing.

Build A Resilient Supply Chain For Your Next-Generation Peptide Therapeutic

As peptide therapeutics continue to establish themselves as a leading technology, drug sponsors must identify reliable peptide building block suppliers to secure high-quality starting materials.

Less Mess, Less Stress, Best Expressed: An Alternative To Spray Drying

Although well-established processes, spray drying and hot-melt extrusion can be outperformed in bioavailability, cost-savings, manufacturing speed, environmental impact, and more.

Leveraging Protein A Capture Technology

See how a Protein A capture technology boosts mAb purification productivity 10-fold, supports membrane-based platforms, and enables intensified processes with improved yields.

Achieving Faster Timelines And Cost Savings Through Digital Validation

Uncover how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

SPONSOR

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

Generic Drug Approvals In Canada Using A Foreign-Sourced Product

Brush up on guidance on how to demonstrate that a foreign-sourced reference drug is acceptable to the Minister of Health as a Canadian reference product for an Abbreviated New Drug Submission and Abbreviated Extraordinary Use New Drug Submission.

SOLUTIONS

Take The Right First Step To Manufacturing Digitalization

Good Clinical Practice

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Industrial Data Operations Software Solution For Life Sciences

Solid Form Services

Programs To Bridge Molecules From Discovery Into Clinical Development

Polyvinyl Alcohol For Hot Melt Extrusion

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