Newsletter | May 9, 2025

05.09.25 -- Amgen's Deep Learning Approach To Vial Inspection

SPONSOR

Webinar: Navigating Regulatory Shifts: EU GMP Annex 1 and USP 382

Join our webinar to explore how to build a robust, evolving Contamination Control Strategy (CCS) aligned with EU GMP Annex 1 and upcoming USP <382> standards. Experts from West—Dr. Ana Kuschel, Todd Jasinski, and Daria Miller—will share insights on supplier alignment, risk mitigation, and fostering a quality-driven culture to help manufacturers meet regulatory expectations and enhance patient safety. Click here to learn more.

INDUSTRY INSIGHTS

Strategies For Successful Manufacturing Of Highly Potent Oral Solids

In this discussion, industry experts explore some of the key challenges in HPAPI drug product manufacturing and highlight essential factors sponsors should consider when evaluating a CDMO.

Project Management To Meet Today's Drug Development Challenges

Gain insights into the steps CDMOs can take to streamline project management to benefit the small and emerging biotech companies they work with.

Optimizing DPI Production: Filling Technologies For Precision, Performance

Developing effective dry powder inhalers requires expertise across multiple disciplines, from particle engineering and device technology to manufacturing science and regulatory knowledge.

Mitigate Risk Of Failure In Biotherapeutic Development

In silico and in vitro protein design and optimization tools help mitigate manufacturing, development and immunogenicity risks to reduce attrition and improve the quality and safety of therapeutic proteins.

The Evaluation Of Vial Container Closure System Components

Review the comparison of two container closure systems that differ by stopper hardness using comprehensive stack-up calculations performed by an innovative modeling platform.

Streamlining Compliance With Pre-Clinical Safety Tests

As cell therapies advance, challenges in ensuring safe and compliant production increase. Discover how to develop efficient strategies to maintain cell viability and functionality throughout the supply chain.

Fluid Management Strategies For Scalable Biopharmaceutical Production

Effective fluid management systems are indispensable in therapeutic manufacturing. Find out how modular design, automation, and single-use systems enhance scalability and maintain product integrity.

The Value Of Peptones For Enhancing Biopharmaceutical Productivity

Uncover why peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.

Achieving Integrated Manufacturing Excellence

Pfizer’s integrated Manufacturing Excellence production system sets out a common way of working that delivers continuous improvement to help increase our speed of getting medicines to patients.

An E-WorkBook That Helps Reduce Study Cycle Times

Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

Overcoming Obstacles On The Journey To Commercialization

See how case studies in the development and manufacturing of APIs and HPAPIs, as well as innovative solutions designed to address and overcome challenges, bring new medicines to patients.

Advanced Cleaning Mechanisms: Cold Or Warm For Proteins?

Warm temperatures can denature some hormones and proteins, causing cleaning problems. Explore how temperature can affect enzymatic and emulsifying activity in cleaning mechanisms.

FEATURED EDITORIAL

Amgen's Deep Learning Approach To Vial Inspection

Traditional automatic visual inspection (AVI) has false rejection challenges. The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

SOLUTIONS

Solving Complex Formulation Challenges From Coast To Coast

Enhance Resolution For Polymer Analysis Using Non-Aqueous GPC/SEC

The Power Of DataOps And Unified Namespace In Unlocking AI

Cleanroom Panels For Pharmaceutical Manufacturing And Packaging

Connected Solutions For Pharmaceutical Labeling

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