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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

resi-drug-substance-background-parallax 1

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 viral vectors, vaccines, mAbs, enzymes, fusion proteins and bispecifics

Cell bank GMP Production
(MCB and WCB) 

BSL1 and BSL2 capable manufacturing suites

resi-manufacturing-equipment

Development and manufacturing capabilities

Development
Vaccines
VACCINES

Single-use bioreactors
(SUBs): 3L - 500L

Viral and recombinant
vaccine process and
analytical development

Pall iCellis Nano

Univercells

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

Bio non-toxic conjugation

Molecular development and
characterization

Continuous manufacturing
development
Viral Vectors
VIRAL VECTORS
Single-use bioreactors
(SUBs): 250mL - 200L

AAV and LVV Platform
processes and analytical
methods

NGS and mass
spectroscopy
charcterization
Vaccines Biologics Viral Vectors
VACCINES/BIOLOGICS/VIRAL VECTORS
Analytical method development and advanced analytics

Process characterization and validation

Process and formulation development

Tech transfer and scale-up

Cell line development

Pilot plant up to 1000L
Manufacturing
Vaccines
VACCINES
Univercells and iCELLis
adherent single-use
bioreactor technology, up to
500m2

Suspension vaccine
manufacturing up to 2000L

Viral, recombinant, and
mRNA vaccines
Biologics
BIOLOGICS
Continuous and fed batch
manufacturing up to 2000L

Monoclonal antibodies,
recombinant proteins,
plasma proteins, conjugates
Viral Vectors
VIRAL VECTORS
Suspension vector
manufacturing up to 2000L

AAV, LVV, Ad, HSV
Vaccines Biologics Viral Vectors
VACCINES/BIOLOGICS/VIRAL VECTORS

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, including: mAbs, fusion proteins, enzymes, bi-specifics, complex recombinant proteins, conjugated proteins, and microbial proteins 

Integrated formulation and fill/finish 

RESI-24-003d-3DKA-07-SC-Pesrp01-BG-2

What's new at Resilience

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

mAbs, proteins, plasmid-derived, mRNA, vaccines, viral vectors (up to BSL-2), peptides, oligonucleotides, small & large molecules

Aseptic liquid formulation

Adjuvant, suspension, and other complex formulations

Fill/finish

  • Vials
  • Pre-filled syringes
  • Cartridges

Automated inspection, device assembly, and packaging

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

Drug Product Scale

Resilience Drug Product Scale per site

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 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 RTP and Cincinnati sites

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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.

NATIONAL RESILIENCE