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Supplier News: Thermo Fisher, Lonza, MilliporeSigma & More 

The latest from CDMOs, CMOs, and suppliers featuring Thermo Fisher Scientific, Lonza, Cytiva, MilliporeSigma, Oxford Biomedica, National Resilience, Siegfried, Celonic, Carbogen Amcis, Asimov, Made Scientific, Syenex, Symbiosis, and Afton Scientific.  

Biologics Manufacturing 
* Oxford Biomedica Acquires Biomanufacturing Plant from National Resilience 
* MilliporeSigma Opens New Filtration Mfg Facility 
* Siegried’s Dinamiqs Opens New Viral Vector Mfg Facility 
* Celonic, Carbogen Amcis Partner for ADC Development, Mfg
* Asimov Launches AAV Mfg Platform  
* Made Scientific in Pacts with Syenex, Streamline Bio for Cell-Therapy Mfg 
Formulation Development/Drug Product Manufacturing 
* Vaxcyte, Thermo Fisher in Up-To $1-Bn Fill–Finish Services Pact 
* Lonza Launches New Aseptic Drug Product Filling Line 
* Symbiosis Expands Sterile Mfg Capacity 
* Afton Scientific Breaks Ground on Sterile Injectables Expansion 
General 
* Cytiva, Copa Data Partner for Automation Control Technology 

Biologics Manufacturing 

Oxford Biomedica Acquires Biomanufacturing Plant from National Resilience 
Oxford Biomedica (OXB), a CDMO of cell and gene therapies, has signed and closed an asset purchase transaction for a cell- and gene-therapy viral vector manufacturing facility in North Carolina from RTP Operating, a subsidiary of National Resilience. 

The acquisition expands OXB’s viral vector manufacturing capabilities in the US up to commercial scale and increases GMP capacity. The FDA-approved facility in Durham, North Carolina, adds scalable vector manufacturing capabilities and end-to-end services across drug substance and fill-finish. This acquisition enables OXB to support late-stage programs and commercial launches from the US for new and existing clients worldwide, particularly in the adeno-associated virus (AAV) field.  

Under the agreement, OXB paid $4.5 million in consideration for the assets, funded by existing cash. Integration planning has commenced, with key functions expected to be operational by the first quarter of 2026.  

Source: Oxford Biomedica 

MilliporeSigma Opens New Filtration Mfg Facility  
MilliporeSigma, the life-sciences business of Merck KGaA, has opened a EUR 150 million ($173 million), 3,000-square-meter filtration manufacturing facility in Blarney Business Park, Cork, Ireland. The site is the company’s first manufacturing facility designed for climate-neutral operations, marking a key milestone in the company’s goal to achieve climate neutrality by 2040. The facility is expected to begin production in the fourth quarter of 2025 and will manufacture filtration devices used in aseptic processing, tangential-flow filtration, and virus filtration. The new site will run on 100% renewable electricity and an innovative heat recovery system, which is estimated to avoid up to 61 metric tons of carbon dioxide equivalents annually. It will also reuse up to 95% of high-purity reverse osmosis water from its filtration manufacturing process. 

Source: MilliporeSigma 

Siegried’s Dinamiqs Opens New Viral Vector Mfg Facility 
Dinamiqs, a Siegfried company, has inaugurated a cGMP manufacturing facility for viral vectors. The new 2,500-square meter cGMP facility brings R&D, clinical, and commercial viral vector manufacturing under one roof, with production capacity up to 1,000-L scale. It features a modular, segregated design and closed, single-use technologies.  

The new facility enables end-to-end manufacturing of viral vector gene therapies, from molecule design to aseptic drug product filling. As part of this facility, new lab space has been operational since the third quarter of 2024. To mark the inauguration, Dinamiqs also announced a strategic collaboration with SEAL Therapeutics to support the development and manufacturing of a gene therapy for severe muscular dystrophy. 

Source: Dinamiqs 

Celonic, Carbogen Amcis Partner for ADC Development, Mfg 
Celonic Group, a biologics CDMO, and Carbogen Amcis, a Bubendorf, Switzerland-based CDMO of drug substances and drug products, have announced a strategic partnership to offer fully integrated antibody-drug conjugate (ADC) development and manufacturing. The alliance combines Celonic’s advanced biologics capabilities with Carbogen’s expertise in payload synthesis, conjugation, and sterile fill-finish. 

The integrated offering includes: 

  • Cell line development and antibody production at scale (Celonic) 
  • Payload and linker synthesis and at-scale manufacturing (Carbogen Amcis) 
  • ADC conjugation and sterile fill-finish (Carbogen Amcis) 
  • Regulatory support and CMC (chemistry, manufacturing and controls) documentation for filings for investigational new drug applications, investigational medicinal product dossiers, and biologics license applications.  

Source: Carbogen Amcis 

Asimov Launches AAV Mfg Platform 
Asimov, a Boston-based manufacturing platform company, has launched its AAV Edge Stable Producer System, an adeno-associated virus (AAV) manufacturing platform. With this launch, Asimov aims to address the shortcomings of traditional transient transfection-based production and bring AAV manufacturing standards closer to those established for antibody-based biologics. A major challenge in AAV gene therapy has been developing scalable, cost-efficient processes to reliably produce high-quality vectors. Most programs still depend on transient production, which requires multiple GMP plasmids to be transfected every batch. 

The new offering delivers research cell banks within 20 weeks that contain the desired capsid and transgene. Therapeutic developers receive clonal, suspension-adapted, fully stable AAV HEK293 producer cell lines to enable manufacture of gene therapies at scale, with titers up to 6E15 vg/L before purification. 

Source: Asimov 

Made Scientific in Deals with Streamline Bio & Syenex for Cell-Therapy Mfg 
Made Scientific, a cell therapy CDMO, has entered deals with Streamline Bio, an autonomous robotics company, and Syenex, a synthetic biology company specializing in targeted delivery technologies. 

Made Scientific and Streamline Bio have announced successful initial validation of Streamline Bio’s AI-driven precision robotics platform in a live cell-therapy production environment. With successful completion of initial validation work at Made Scientific’s Princeton, New Jersey, facility, the companies are now advancing the path toward GMP integration, including the launch of early-adopter programs, and collaboration on deploying the fully robotic cell-therapy manufacturing solution.  

Separately, Made Scientific and Syenex have announced a technology partnership to advance the scalability and efficiency of engineered T cell therapies through the use of Syenex’s bioengineering systems, UltraCell and RapidCell, providing improvement in gene delivery efficiency and engineering timelines.  

Syenex and Made Scientific will continue to build upon initial proof of concept with Syenex’s bioengineering platforms to address scalability and cost challenges of traditional lentiviral- and retroviral-vector-engineered T cell therapy manufacturing. These systems offer up to 10x improvement in gene delivery efficiency, may enable reduced manufacturing timelines, and lower cost of goods through advanced delivery vector engineering, according to the company.  

Source: Made Scientific 

Formulation Development/Drug Product Manufacturing 

Vaxcyte, Thermo Fisher in Up-To $1-Bn Fill–Finish Services Pact 
Vaxcyte, a clinical-stage vaccines company, has announced a new agreement with Thermo Fisher Scientific for Thermo Fisher to provide additional fill-finish commercial manufacturing for Vaxcyte’s broad-spectrum pneumococcal conjugate vaccines (PCVs), in a deal worth up to $1 billion. 

Thermo Fisher will provide custom commercial fill–finish capacity for Vaxcyte’s broad-spectrum PCVs at Thermo’s Greenville, North Carolina, facility. The initiative, including both manufacturing and related services, represents a long-term US commercial manufacturing commitment for Vaxcyte representing up to $1 billion. 

Source: Vaxcyte 

Lonza Launches New Aseptic Drug Product Filling Line 
Lonza has announced the operational readiness of its new aseptic drug-product filling line, designed for biologics and highly potent products, such as antibody-drug conjugates.. 

The filling line was granted a GMP license following Swissmedic approval and strengthens Lonza’s existing capacity for liquid and lyophilized vial filling while introducing advanced containment technology to safely manufacture highly potent biologics. 

Source: Lonza 

Symbiosis Expands Sterile Mfg Capacity 
Symbiosis, a sterile fill-finish CDMO, has successfully completed qualification of its new FPD 50 Flexicon automated fill-finish line at its new commercial production facility in Stirling, Scotland. 

The system operates under a Grade A Restricted Access Barrier System (RABS). It incorporates rapid transfer ports for aseptic handling and high-accuracy vial filling with pump technology. The system also features a rotary crimp mechanism to ensure consistent overseal application and secure closure. 

Symbiosis will commence commercial production at the new facility in the fourth quarter of 2025, manufacturing batches of up to 15,000 vials, and representing the latest in a series of recent milestones for the company. 

Source: Symbiosis 

Afton Scientific Breaks Ground on Sterile Injectables Expansion 
Afton Scientific, a CDMO of sterile injectables, has broken ground on a $200-million sterile injectables manufacturing expansion at its site in Albemarle County, Virginia. The expansion was first announced in October 2024. 

Source: Virginia Governor’s Office 

General

Cytiva, Copa Data Partner for Automation Control Technology 
Cytiva and Copa-Data, an industrial automation software company, are collaborating to develop and implement Module Type Package (MTP) technology into Cytiva’s Unicorn control platform. 

For industrial automation, MTP simplifies modular process automation, wherein a manufacturing process is divided into mobile modules that can be easily swapped or re-configured for different production needs. Key benefits of MTP include: 

  • Faster integration of Cytiva ÄKTA systems running on Unicorn software with overarching site systems; 
  • Reduced engineering and validation efforts for customers since less custom coding is required; 
  • Time savings and cost reductions; 
  • Improved flexibility, scalability, and cross-vendor compatibility; and 
  • Scalability, allowing plants to adapt to changing production needs without overhauling entire systems. 

The collaboration aims to introduce new solutions by 2026. 

Source: Cytiva