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Health Manufacturing & Supply Chain

AGC Biologics and ATUM Link Up to Speed Cell Line Development for Complex Biologics

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AGC Biologics and ATUM Link Up to Speed Cell Line Development for Complex Biologics

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics is expanding its Cell Line Development Center of Excellence through a new partnership with ATUM, integrating the Leap-In Transposase® expression platform to help biopharma developers move monoclonal antibodies and complex next-generation biologics into the clinic faster and more cost-effectively.

New options for faster, more flexible cell line development

As pressure grows to launch high-value biologics at lower cost, drug sponsors are looking for cell line development (CLD) solutions that combine speed, robustness and scalability. AGC Biologics' collaboration with ATUM adds a modern transposase-based expression platform to its CLD toolkit, creating a menu of fit-for-purpose options for standard monoclonals, multi-specific antibodies and other complex molecules.

Regeneron and Scholar Rock Reroute Fill/Finish as Novo's Indiana Plant Faces FDA Heat

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Regeneron and Scholar Rock Reroute Fill/Finish as Novo’s Indiana Plant Faces FDA Heat

SHERIDAN, WYOMING - December 2, 2025 - A series of FDA findings at Novo Nordisk's Bloomington, Indiana, fill/finish facility is forcing biotechs to rethink their commercial manufacturing strategies, with Regeneron and Scholar Rock now accelerating alternative capacity plans to break regulatory logjams linked to the ex-Catalent site.

FDA scrutiny at Novo's Bloomington site triggers CRLs

The Bloomington plant, one of three former Catalent sites Novo acquired for $11 billion to support surging GLP-1 demand, has become a bottleneck rather than a release valve for some of its biopharma customers. As a CDMO hub, the facility provided fill/finish services for a range of partners, but repeated quality issues have resulted in an Official Action Indicated (OAI) classification and multiple complete response letters (CRLs) from the FDA.

AGC Biologics Tackles Speed, Scale and Yield in Next-Generation Microbial Manufacturing

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AGC Biologics Tackles Speed, Scale and Yield in Next-Generation Microbial Manufacturing

SHERIDAN, WYOMING - December 2, 2025 - Microbial fermentation is moving back to the center of biologics manufacturing strategy, and contract development and manufacturing organizations (CDMOs) like AGC Biologics are under pressure to turn the platform's greatest strength-speed-into a reproducible, industrial-scale advantage.

Microbial fermentation's resurgence - and its speed problem

Microbial systems have long been valued for fast, efficient production of biologics, and they are now seeing renewed interest for a new generation of therapies. Yet the same speed that makes microbial fermentation attractive also makes it unforgiving. Typical production runs last around 48 hours, leaving very little time to diagnose and correct process deviations once a run is underway.

FDA's PreCheck Strategy Faces Industry Pressure to Include Existing Drug Manufacturing Sites

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FDA Lifts Black Box Warning on Hormone Therapy, Resetting a Two-Decade Regulatory Framework

SHERIDAN, WYOMING - November 13, 2025 - Drug manufacturers are urging the FDA to broaden its proposed PreCheck program beyond new factory construction, warning that excluding existing facilities could slow U.S. efforts to expand pharmaceutical production capacity. At a recent agency meeting, representatives from companies spanning gene therapy, generics, and biologics argued that PreCheck's current scope overlooks the fastest route to alleviating drug shortages and strengthening domestic supply chains.

Early-Stage Regulatory Support Designed Only for New Sites
PreCheck was introduced to streamline the regulatory oversight of newly built manufacturing plants, giving participating companies earlier FDA engagement well before their first commercial product application. The program is meant to make U.S. construction more attractive by reducing uncertainty and aligning expectations early in the buildout process.

Canon Secures iF Design Award Gold for Adastra Series, Marking 31 Years of Design Excellence

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Global Automotive Alloy Wheel Market Gains Momentum as OEMs Double Down on Lightweight Design

SHERIDAN, WYOMING – May 6, 2025 – Canon Inc. has once again solidified its standing in the global design arena by winning the prestigious iF Design Award for the 31st consecutive year. In a milestone achievement, Canon’s Adastra2 series of semiconductor and electrical component manufacturing equipment claimed the coveted Gold Award—underscoring the company's sustained leadership in industrial innovation and product design.

This year's recognition, granted by Germany’s iF International Forum Design GmbH, saw 111 Canon Group products awarded across categories. The Gold Award for the Adastra2 series marks a strategic victory for Canon as it continues to align high-performance manufacturing systems with world-class design standards—a move that positions the company at the forefront of both operational and aesthetic excellence in industrial equipment.

A Strategic Win in the Semiconductor Manufacturing Space

3M Delivers Strong Q1 2025 Results Amid Strategic Transformation and Margin Growth

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13th MEDICA MEDICINE + SPORTS CONFERENCE to Spotlight Science-Driven Health and Performance Strategies

SHERIDAN, WYOMING – May 5, 2025 – Global science and innovation leader 3M (NYSE: MMM) announced robust first-quarter 2025 results, underscoring its successful focus on operational improvement, disciplined portfolio management, and enhanced shareholder value despite a dynamic macroeconomic environment.

With adjusted earnings per share (EPS) up 10% year-on-year and margins outpacing expectations, the company continues to execute on its performance-driven agenda while navigating global supply chain complexities, regulatory changes, and the ongoing divestiture of its health care business.

Solid Financial Performance Reflects Margin Discipline and Execution