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Empowering the future of medicine

Audacious. Agile. Advanced. Getting the best medicines to patients faster demands everyone bring their “A game.” We’re ready to put our collective talent and resources to work, freeing you from the obstacles impeding the success of your novel therapy.

Drug Substance

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Clinical and commercial drug substance manufacturing services to support your product's growth.

With integrated multi-product facilities all within North America, we are positioned to manage your program's unique needs from development to scale-up from early phase to commercial tech transfer.

Best-in-class capabilities: 

Certified multi-product facilities all located within North America 

Strong network of facilities, equipment, materials, digital solutions, and operational excellence to fit your program’s specific needs 

Early phase to commercial tech transfer expertise with established stage-gate approach 

Extensive experience and expertise in various products, including mAbs, enzymes, fusion proteins, and bispecifics

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Development and manufacturing capabilities

Development
Biologics
BIOLOGICS
Single-use bioreactors
(SUBs): 3L - 500L

Bio non-toxic conjugation
Biologics Viral Vectors
BIOLOGICS + CELL THERAPY
Analytical method development and advanced analytics

Process characterization and validation

Tech transfer and scale-up
Manufacturing
Biologics
BIOLOGICS

Monoclonal antibodies, recombinant proteins, plasma proteins, conjugates

Single-use bioreactors (SUBs):
50L - 2000L

Analytical method qualification and validation for in-process, release and stability testing

Clinical and commercial manufacturing

Integrated aseptic fill/finish

Advance with confidence

Process optimization and scale-up for reduced COGs  

Optimization of clinical programs for robust and reliable commercial supply of bulk drug substances

Accelerated process and analytical development for speed to early clinical introduction

Process characterization and validation to support late-stage clinical and commercial manufacturing 

Wide range of experience with biologics, including: mAbs, fusion proteins, enzymes, bi-specifics, complex recombinant proteins, conjugated proteins, and microbial proteins

Integrated formulation and fill/finish 

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What's new at Resilience

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November 20, 2025
Resilience Announces Long-Term Financing of up to $825 Million to Accelerate CDMO Strategy
Press Release . Biomanufacturing . Drug Product . Sterile Fill/Finish . In The News . Financing
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November 20, 2025
Redefining CAR-T Speed and Strength with DAR-T™: A Conversation with Nicholas Kirian
Cell Therapy . Technology . Resources
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October 29, 2025
Resilience Announces Long-Term Financing of up to $825 Million to Accelerate CDMO Strategy
Press Release . Biomanufacturing . Drug Product . Sterile Fill/Finish . In The News . Financing
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July 11, 2025
How integrated data systems enhance clinical development and manufacturing
Biomanufacturing . Tech Transfer . Technology . Development
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June 27, 2025
CDMOs Are Making Their Supply Chains More Resilient & Secure
Biomanufacturing . In The News . Development
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June 05, 2025
Navigating the Evolving Landscape of Fill/Finish: Trends, Challenges, and What’s Ahead
Biomanufacturing . Drug Product
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May 08, 2025
On Demand Webinar:  Fill/Finish Services - Outsourced Pharma Capacity Update
Biomanufacturing . Drug Product . Sterile Fill/Finish . Webinar
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May 06, 2025
Cell Therapy Innovations: Reducing Costs to Improve Patient Access
Cell Therapy . Biomanufacturing
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March 28, 2025
Executive Interview: Advancing Therapies That Transform Lives
Company Culture
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March 26, 2025
Resilience and JobsOhio Announce Continued Partnership and Expansion in Blue Ash
Press Release . Biomanufacturing . Drug Product . In The News . Partnerships
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January 30, 2025
Presentation: Rapid Multi-Omics Cell Therapy Characterization and QC
Cell Therapy . Technology . Presentation . Resources
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January 29, 2025
Whitepaper: 3-Day Short Cycle CAR-T Manufacturing Process
Cell Therapy . Technology . White Paper . Resources
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January 15, 2025
Resilience is proud to support CARGO Therapeutics' novel allogeneic CAR-T cell therapy
Press Release . In The News . Media Coverage
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January 14, 2025
Presentation: Expedited Cell Therapy QC: Sample in, to QC Report in 48 Hours 
Cell Therapy . Technology . Presentation . Resources
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January 08, 2025
Resilience Partners with Parvus Therapeutics for Development and Manufacturing of PVT401, a Novel Autoimmune Drug Candidate for IBD
Press Release . In The News . Media Coverage
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December 05, 2024
Resilience Announces Appointment of William S. Marth, RPh., MBA as Chief Executive Officer
Press Release . Company Culture . In The News . Media Coverage
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November 05, 2024
On-Demand Webinar: Outsourced Pharma Capacity Update - Drug Substance
Biologics . Facilities . Webinar . Presentation . Drug Substance
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October 28, 2024
Key Steps in the Vaccine Scale-up Journey
Vaccines . Regulatory
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October 03, 2024
Resilience Secures Funding to Expand Domestic Manufacturing for Critical Pharmaceutical Ingredients
Press Release . Biomanufacturing . In The News . Media Coverage . Government/NGO
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September 30, 2024
Resilience Appoints Dr. Susan Billings, Chief Commercial Officer
Press Release . Company Culture . In The News . Media Coverage
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July 10, 2024
Boston, MA: Process & Analytical Development and Manufacturing Facility
Vaccines . Biologics . Facilities . Gene Therapy . Process and Analytical Development . Resources
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July 01, 2024
On-Demand Webinar: Outsourced Pharma Capacity Update - Fill/Finish
Drug Product . Sterile Fill/Finish
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June 27, 2024
On-Demand Presentation: Improving cell line development in CHO with a focus on product manufacturability
Biologics . Presentation . Resources
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June 27, 2024
Meet the Team: Viral Vector Development & Manufacturing
Gene Therapy . Biomanufacturing . Tech Transfer . Company Culture . Process and Analytical Development
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June 05, 2024
Alachua Campus Tour Video
Government/NGO
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May 02, 2024
Revised Annex 1 and the Focus on Microbial Control Strategies
Biomanufacturing . Drug Product . Regulatory . Sterile Fill/Finish . Resources
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April 25, 2024
Starburst Data Rebel Awards: Data Product of the Year
In The News . Awards . Technology
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March 25, 2024
Building Velocity into Fill/Finish Timelines: Your Guide to Quality and Regulatory Success in the CDMO Space
Biomanufacturing . Drug Product . Tech Transfer . Sterile Fill/Finish . Resources
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March 07, 2024
On-Demand Webinar: Outsourced Pharma Capacity Update 2024 - Large Molecules
Vaccines . Biologics . Facilities . Biomanufacturing . Drug Product . Tech Transfer . Process and Analytical Development
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February 23, 2024
On-demand Webinar: Optimize research and delivery of complex medicines using data insights
Webinar . Partnerships . Technology
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February 20, 2024
Resilience Expands Clinical and Commercial Drug Product Manufacturing Capabilities and Capacities
Press Release . In The News . Partnerships
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February 19, 2024
Scale Your Vaccine Development with Path-to-PAD
Vaccines . Process and Analytical Development
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February 13, 2024
How Resilience Is Bringing Forward Thinking to Disrupt the Biomanufacturing Landscape to Increase Access to Medicines
Company Culture
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February 05, 2024
National Resilience and Taiwan Bio-Manufacturing Corporation Announce Groundbreaking Partnership in Biomanufacturing Innovation
Press Release . In The News . Partnerships
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January 11, 2024
Successful Development and Manufacturing of Vaccines Containing Aluminum Adjuvants
Vaccines . Sterile Fill/Finish
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January 04, 2024
Developing New Medicines Through Artificial Intelligence
Technology . Artificial Intelligence . Protein-Engineering
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January 04, 2024
Resilience to Present at the 42nd Annual J.P. Morgan Healthcare Conference
Press Release . In The News
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December 21, 2023
The Stage-Gate Model: A Proven Approach to Streamline Biomanufacturing
Tech Transfer . Technology . White Paper . Resources
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December 20, 2023
Resilience builds lab supply chain tracking platform on AWS
Biomanufacturing . Partnerships . Technology
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December 12, 2023
On-demand Video: Efficiency Meets Economy: The Power of Single-Use Chromatography in mAb Purification
Biologics
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December 11, 2023
Resilience Announces Expansion in West Chester
Press Release . In The News . Partnerships
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November 30, 2023
How digital twins help improve biomanufacturing quality and security
Digital Twins . Technology
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November 17, 2023
On-demand Video: Idea to Clinic – Aim to Reduce your Manufacturing Timeline by ~30%
Biologics . Biomanufacturing
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November 07, 2023
Resilience Appoints Bill Marth as President of Services
Press Release . Partnerships
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October 26, 2023
Accelerating Clinical Timelines of Induced Pluripotent Stem Cells (iPSCs) with Pluristyx
Cell Therapy . Biomanufacturing . In The News . Partnerships
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October 03, 2023
BridgeBio and Resilience Announce Strategic Multi-Year Partnership
Press Release . Partnerships
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August 29, 2023
The Challenges and Solutions for Viral Products
Vaccines . Biomanufacturing
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August 28, 2023
How Early-Phase Companies Can Future-Proof Their Cell Therapies
Cell Therapy . Process and Analytical Development
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August 28, 2023
Resilience Announces Joint Venture with Lifera in Saudi Arabia
Press Release . Partnerships
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July 13, 2023
Opening of Resilience's West Coast Cell Therapy PAD Center
Cell Therapy . Biomanufacturing . In The News
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July 12, 2023
On-Demand Webinar: High-Throughput Process & Analytical Platforms to Accelerate Gene Therapy Scale-Up
Gene Therapy . Process and Analytical Development
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July 05, 2023
Overcoming Obstacles in Gene Therapy Manufacturing
Gene Therapy . Biomanufacturing
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May 23, 2023
On-Demand Webinar: Future-Proof Your Aseptic Filling
Webinar
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May 16, 2023
Resilience Enters Into Strategic Collaboration with Labcorp to Accelerate Cell and Gene Therapies
Cell Therapy . Gene Therapy . Biomanufacturing
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May 11, 2023
Problem Solving for Aseptic Filling
Drug Product . Sterile Fill/Finish
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May 08, 2023
On Demand Webinar: Outsourced Pharma Capacity Update-Large Molecules
Vaccines . Biologics . Facilities . Biomanufacturing . Drug Product . Tech Transfer . Process and Analytical Development
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May 04, 2023
Leveraging Partnerships to Achieve Cell Therapy Success
Cell Therapy . Biomanufacturing
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April 03, 2023
Master Cell Banks: Laying the Foundation to Final Product Success
Gene Therapy . Biomanufacturing
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March 24, 2023
Resilience Approved For $410M Financing From The Department Of Defense, In Partnership With The Development Finance Corporation, To Establish Resilient Biomanufacturing Capacity
Press Release . Financing
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March 23, 2023
Looking Ahead: What Does the Future Have in Store for Nucleic Acid-Based Therapies?
Nucleic Acids
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February 16, 2023
Resilience Signs Multi-Year Strategic Biomanufacturing Partnership With Leading Pharmaceutical Company
Press Release
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January 25, 2023
Alachua Biomanufacturing Expansion Video
Vaccines . Biologics . Gene Therapy . Biomanufacturing . Drug Product . Tech Transfer . Sterile Fill/Finish
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January 10, 2023
Resilience Announces Equity Investment From Mubadala And Funding Of New Biopharma Manufacturing Facility In The United Arab Emirates
Press Release
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January 03, 2023
Resilience to Establish Biomanufacturing Partnership with AstraZeneca and Purchase Manufacturing Site
Vaccines . Biologics . Biomanufacturing . Sterile Fill/Finish
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November 29, 2022
Cell Therapy – What Does It Take To Become a Mainstream Option
Cell Therapy . Biomanufacturing . Resources
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November 29, 2022
On Demand Drug Substance Manufacturing and Drug Product Fill/Finish Solutions Presentation
Biologics . Biomanufacturing . Drug Product . Tech Transfer . Sterile Fill/Finish . Process and Analytical Development . Webinar
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November 29, 2022
Resilience To Establish A Biomanufacturing Partnership With AstraZeneca And Purchase AstraZeneca’s Manufacturing Site In West Chester, Ohio
Press Release
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October 12, 2022
National Resilience Honored By Goldman Sachs For Entrepreneurship
Press Release
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October 05, 2022
On-Demand Webinar: Establishing a Stage-Gate Approach to Biomanufacturing
Webinar
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August 23, 2022
Resilience Becomes Biomanufacturing Resource Partner For California Institute For Regenerative Medicine
Press Release
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August 15, 2022
Resilience Announces Collaboration To Manufacture And Deliver Biotherapeutics For Rare And Complex Conditions
Press Release . Partnerships
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June 08, 2022
The Parker Institute For Cancer Immunotherapy And Resilience Announce Strategic Alliance To Develop Next-Generation Cancer Therapies
Press Release . Partnerships
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June 06, 2022
Resilience Announces $625 Million Series D Financing To Expand Network, Bring Innovative Technologies To Biomanufacturing
Press Release
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June 02, 2022
Resilience And MD Anderson Launch Joint Venture To Accelerate Development And Manufacturing Of Innovative Cell Therapies For Cancer
Press Release . Partnerships
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February 15, 2022
Resilience Establishes Multi-Product Development And Manufacturing Collaboration With Takeda’s Plasma-Derived Therapies Business Unit
Press Release
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February 09, 2022
Resilience Subsidiary Ology Bioservices Awarded Contract Worth Up To $250 Million From U.S. Department Of Defense For Botulinum Neurotoxin Treatment
Press Release
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December 02, 2021
Resilience Acquires SwiftScale Biologics, A Leader In Cell-Free Protein Synthesis Technology
Press Release
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October 15, 2021
Resilience And Harvard University Announce Five-Year R&D Alliance To Incubate New Technologies, Launch Companies To Advance The Manufacture Of Complex Medicines
Press Release . Partnerships
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October 12, 2021
Resilience Joins Forces With Children’s Hospital Of Philadelphia To Develop Next-Generation Biomanufacturing Technologies, Create Impactful Therapies
Press Release
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September 08, 2021
Resilience To Manufacture mRNA For Moderna’s COVID-19 Vaccine
Press Release
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August 02, 2021
Meet The 24 Biotech Startups That Top VCs Say Are Poised To Take Off In The next 12 Months
In The News
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July 28, 2021
Bluebird Bio And Resilience Announce Strategic Alliance To Develop Next Generation Cell Therapies
Press Release
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May 18, 2021
Resilience Receives USD $164 Million Investment From The Government of Canada to Modernize and Expand Its Ontario Biomanufacturing Site, Improving Pandemic Preparedness
Press Release . Financing
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April 12, 2021
Resilience Continues Expansion With Acquisition Of Biologics Manufacturing Company Ology Bioservices
Press Release
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March 03, 2021
How An East Bay Site May Lead A Biotech Manufacturing Revolution
Press Release
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March 02, 2021
With Stars Aligned And Cash In Reserve, Bob Nelsen’s Resilience Plans A Makeover At 2 New Facility Additions To Its Drug Manufacturing Upstart
Press Release
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March 02, 2021
Resilience Expands North American Capacity With The Acquisition Of Two Premier Biologics Manufacturing Facilities
Press Release
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February 16, 2021
Fireside Chat With Rahul Signhvi, CEO Of Resilience
Press Release
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February 15, 2021
Resilience Bags Sanofi-Genzyme Plant In Boston
Press Release
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February 11, 2021
Sanofi Prepares To Transfer Allston Plant To A New Company, But Not Its City Tax Breaks
Press Release
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November 30, 2020
Raging At The Pandemic, A VC Raises $800M For A Company That Aims To Transform Biotech Manufacturing
In The News
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November 23, 2020
Resilience Launches To Change The Future Of Medicine Through Manufacturing Innovation
Press Release

Drug Product

resi-drug-product-background

Clinical and commercial drug product manufacturing 

Resilience is ready to deliver to your team the benefits that can only come from setting a new pace in drug product manufacturing. When you work with us, you’ll access our unique, interconnected network, specifically designed to address the breakpoints inherent in traditional drug product manufacturing so that no single point of failure will set you back.

 

Best-in-class capabilities:

Fill/finish of therapeutics, non-viral vaccines, and other emerging technologies:

mAbs, proteins, plasmid-derived, mRNA, non-viral vaccines, peptides, oligonucleotides, small & large molecules

Aseptic liquid formulation

Adjuvant, suspension, and other complex formulations

Fill/finish

  • Vials
  • Pre-filled syringes
  • Cartridges

Visual inspection

  • Manual, semi-automated, and high-speed, fully-automated visual inspection
  • In-process CCIT capabilities with high-speed visual inspection

Device assembly and packaging

  • APFS, Ypsomed AI, SHL AI platform for device assembly
  • Can support additional device and proprietary platforms
  • Bulk, multi-unit and single unit PFS, cartridge and vial labeling & packaging
  • Serialization and aggregation

Drug Product Scale

Drug Product Scale 10212025-1

Advance with confidence

Rapid tech transfer capabilities

Clinical and commercial GMP and non-GMP manufacturing experience with a proven track record for execution (250+ fill/finish batches)

Regulatory and quality team with an average of 20+ years of experience at the forefront of regulatory and quality compliance for multiple modalities

In-house and 3PL ambient and cold storage capabilities (expansion underway for in-house and 3PL cold storage)

In-house analytical and service testing and stability

Experienced in forming strategic collaborations to onboard new capabilities and capacity

Clinical and commercial PFS/Vial/Device Assembly & Packaging expansions underway at Cincinnati site

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Speak with an expert

You’ve no doubt filled out a million forms before. But this is the first one to us – and we’re excited to hear from you. Let’s see if your biomanufacturing needs and our capabilities are a good match.

RESILIENCE