Operational Excellence

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.

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics has signed a new manufacturing agreement with AAVantgarde Bio to produce dual-vector AAV gene therapies for Stargardt disease and retinitis pigmentosa, positioning its BravoAAV™ platform at the center of next-generation treatments for inherited retinal disorders with no approved therapies.

Dual-vector AAV platform targets previously "untreatable" retinal genes

Under the deal, AGC Biologics will provide GMP manufacturing for AAVantgarde's two clinical-stage candidates: AAVB-039 for Stargardt disease, the most common inherited form of macular degeneration in children and young adults, and AAVB-081 for retinitis pigmentosa caused by Usher syndrome type 1B. Both programs are in Phase 1/2 trials, with AAVB-039 being tested in the U.S., UK and Europe, and AAVB-081 representing the first-ever dual AAV gene therapy in an ocular indication.

SHERIDAN, WYOMING - December 2, 2025 - Heidelberger Druckmaschinen AG (HEIDELBERG) is restructuring its largest site in Wiesloch-Walldorf, appointing long-time manager Orhan Bekyigit as plant director alongside his existing role as site head, in a move designed to sharpen competitiveness, streamline operations and support growth in international markets.

Strategic realignment at Heidelberg's largest production hub

The Wiesloch-Walldorf campus, with around 3,800 employees, is HEIDELBERG's biggest location worldwide and a central pillar of its global manufacturing and technology network. The new setup brings plant management and central site functions under one leadership, with Bekyigit now responsible for both operational execution and cross-site coordination.

SHERIDAN, WYOMING - December 2, 2025 - More than 3,000 print service providers worldwide are now using the cloud-based HEIDELBERG Customer Portal as a digital control center for their end-to-end production, underscoring how system integration and workflow automation are becoming decisive competitive factors in the global print and packaging industry.

Cloud platform becomes a digital command center for print plants

Three years after launch, Heidelberger Druckmaschinen AG's (HEIDELBERG) customer portal is evolving into a central hub for managing production, service and commercial processes. Over 7,000 individual users are actively leveraging the platform to digitalize and automate their operations, with a clear focus on improving efficiency, transparency and sustainability.

SHERIDAN, WYOMING - December 2, 2025 - Swiss communications provider rubmedia has commissioned a compact, highly automated Heidelberg digital print line at its new site in Köniz near Bern, combining a Jetfire 50 inkjet system, a Versafire LV toner press and integrated workflow software to industrialize personalized short-run production.

Digital production line anchors new Köniz facility

With around 35 employees, rubmedia positions itself as a media house focused on creative communication solutions for service providers, industry, associations and political customers. As part of an internal transformation project linked to its relocation, the company rethought its production strategy and installed a tightly integrated digital line designed for efficiency, quality and automation.

SHERIDAN, WYOMING - December 2, 2025 - Heidelberger Druckmaschinen AG (HEIDELBERG) is reporting a significantly more profitable first half of its 2025/2026 financial year, with revenue growth, a doubling of EBITDA and improving cash flow underscoring the impact of its restructuring program and strategic focus on packaging, label and digital print.

Stronger top line and sharply improved margins

In the six months from April 1 to September 30, 2025, HEIDELBERG grew revenue to €985 million, around 8% above the prior-year period's €915 million. Europe and Asia were the main regional growth engines, while the second quarter contributed €519 million, up from €466 million in the first quarter despite negative currency effects of roughly €12 million versus the prior-year quarter.

SHERIDAN, WYOMING - December 2, 2025 - Roche has secured FDA 510(k) clearance with a CLIA waiver and CE IVDR certification for its first point-of-care test to diagnose Bordetella infections, providing primary care and emergency clinicians with PCR-accurate results in just 15 minutes to help control whooping cough and related diseases.

Fast, PCR-accurate diagnosis at the point of care

Running on the cobas® liat system, Roche's new assay delivers lab-quality PCR results in GP offices and emergency rooms within a standard consultation. The 15-minute turnaround allows physicians to move from suspicion to definitive diagnosis immediately, supporting timely antibiotic prescribing that can prevent severe complications and reduce onward transmission.

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.

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.

SHERIDAN, WYOMING - December 2, 2025 - With energy prices volatile and brand owners under pressure to cut carbon and costs, Sidel's EvoBLOW Laser technology is emerging as a strategic lever for beverage, food, home and personal care producers looking to modernize PET blowing operations. Following its breakthrough launch at drinktec and one year of industrial use in the field, President & CEO Pietro Cassani is outlining how the system's performance, simplicity and lightweighting potential are reshaping expectations for next-generation blowing equipment.

Laser-based blowing targets efficiency and TCO head-on

For producers operating high-speed PET lines, the shift from traditional halogen to laser-based blowing is more than a technical upgrade. It directly affects line efficiency, energy consumption and total cost of ownership across increasingly complex packaging portfolios.