Newsletter | October 31, 2025

10.31.25 -- From Lab to Plant: Managing Operational Environment During Scale-Up

SPONSOR

Webinar: USP <1062> Tablet Compression Characterization: Practical Applications

Join Natoli Engineering's Bill Turner and Robert Sedlock for an in-depth, expert-led webinar on the latest innovations improving tablet compression efficiency and quality. Gain practical insights into optimizing production with technologies like the EZ Level™ System, FastLok™ Replaceable Die Table Plates, Segment Turrets, and LVS Advanced inspection. Learn how the Natoli Advantage Program enhances productivity, reduces costs, and ensures superior tablet quality. Click here to learn more.

INDUSTRY INSIGHTS

Vision Inspection Software: The Missing Link In Digital Transformation

AI and MES can’t meet pharma’s visual inspection demands. Discover how purpose-built software ensures defect detection, compliance, and paperless quality for safer, more efficient operations.

Is Lipinski's Rule Of Five Still Relevant In Drug Development?

Some drugs violate multiple Ro5 elements but remain developable, while some molecules adhere strictly to the Ro5, but their properties are not conducive to development.

Cleanroom Design Paradigm: Converting Spaces For GMP Operations

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.

FROM THE EDITOR

From Lab to Plant: Managing Operational Environment During Scale-Up

Though these challenges can result from equipment, raw material differences, and process variability, operational environments must be a major focus during lab trials, as Yuhei Yamamoto and his team at Takeda learned in a recent experience.

INDUSTRY INSIGHTS CONTINUED

Modernizing CSV: How AI And CSA Are Changing The Game

Explore how companies are streamlining validation with AI and CSA principles, as well as practical strategies that boost efficiency, accuracy, and compliance—backed by real-world examples.

Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?

Real-time viable particle monitoring instruments have been available for over a decade. Read in detail about this technology and how it is used to detect viable particles in real time.

Building Digital Capabilities For An Intelligent Tomorrow

See how modern manufacturing software is transforming operations with AI-driven insights to empower CDMOs and CMOs to boost efficiency, agility, and client satisfaction in a competitive landscape.

MES Vs. Operations Platform

Discover a comprehensive guide comparing traditional manufacturing execution systems and operations platforms to help you choose the right solution for your business.

Guide To PUPSIT And Annex 1 In Aseptic Processing

Pre-use, post-sterilization integrity testing ensures filters remain undamaged and effective during aseptic manufacturing. Find out how you can successfully perform PUPSIT with proven solutions.

Experimental Pain Models — SNL Model Of Neuropathic Pain

Uncover how a validated Spinal Nerve Ligation (SNL) model enables effective preclinical evaluation of novel analgesics for neuropathic pain.

Sustainable Solutions For Medical Devices

Delve into how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

Accelerating Method Development And Manufacturing Of GLP-1 Analogs

Examine a streamlined LC-UV/MS workflow that empowers labs to meet rising GLP-1 drug demand with faster, more informed decisions that enhance compliance and impurity detection efficiency.

Speed To Market – API Large-Scale Commercial Manufacturing

Learn 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.

Optimizing The Progression Of Biotherapeutic Candidates To FIH Studies

Review actionable strategies that can lead to higher success rates and smarter resource investment, paving the way for a successful path to IND submissions and commercialization.

SOLUTIONS

Thermofluor Screening For Injectable Protein Formulations

Leveraging Our Extensive Inspection Experience

Thermal Analyzers For The Most Demanding Biopharma Applications

Integrated ADC Offering: From Concept To Commercialization

Enabling Boundless Automation In The Life Sciences Industry

Supporting Global Pharma Partners With Flexible, Reliable Solutions

Building The CDMO Of The Future

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