• Biologics
    • Modalities
      • Mammalian
      • Microbial
      • ADCs / Bioconjugates
      • mRNA / LNP
      • Drug Product
    • Technologies & Products
      • Expression Technologies
      • Discovery Products
      • Bioprocessing Products
    • Discovery and Preclinical
      • Early De-risking & Optimization
      • Cell Line & Strain Development
      • Process Development & Optimization
      • Analytical Development
      • Formulation Development
      • Non-GMP Manufacture
    • Clinical and Commercial
      • Process Development & Optimization
      • Formulation Optimization
      • cGMP Drug Substance Manufacture
      • cGMP Drug Product Manufacture
    Technical Support
    Regulatory Support
    View all locations
    View all Biologics offerings
    Woman and microscope

    Knowledge Center

    View all the latest resources available on site


    Visit our Knowledge Center

  • Small Molecules
    • Services
      • Drug Substance (API)
      • Particle Engineering
      • Drug Product
    • Technologies
      • Highly Potent API (HPAPI)
      • ADCs
      • Spray Dried Dispersions
      • Micronization & Jet Milling
      • Inhaled Delivery (DPI)
    • Solutions
      • Early Phase API
      • Commercial Production API
      • Bioavailability Enhancement
      • Integrated Offerings
    • Knowledge Center
      • Webinars
      • Presentations
      • Publications
      • Meet the Experts
      • View all
    View all Small Molecules offerings
    View all locations
    Clinical drug development & preformulation

    Knowledge Center

    View all the latest resources


    Visit our Knowledge Center

  • Cell & Gene
    • Services
      • Process Development
      • cGMP Manufacturing
      • Regulatory Consulting
      • Bioassay Services
      • Tissue Acquisition
    • Modalities
      • Autologous
      • Allogeneic
      • Viral Vectors
      • iPSCs
      • Exosomes
    • Technologies
      • MODA® Platform
      • Cocoon® Platform
      • Nucleofector® Technology
      • TheraPEAK® Media
      • Endotoxin and Pyrogen Testing
    • Knowledge Center
      • Webinars
      • Articles
      • Whitepapers & Publications
      • eBooks
      • Presentations
      • View all
    View all Cell & Gene offerings
    View all Bioscience Products
    View all locations
  • Capsules & Health Ingredients
    • Health Ingredients
    • Nutraceutical capsules
    • Pharmaceutical capsules
    • Capsule filling equipment
  • Contact
  • Trending Topics
    New Cambridge, USA Lab Expands Our Early De-risking Capacity
    Upcoming Conference PEGS Boston 2023, USA
    New Whitepaper: Optimization of mRNA Manufacturing
    Shaped Around You - Committed to your molecule’s IND
    New Whitepaper: Late-Phase Drug Product Development and Launch
Trending Topics
New Cambridge, USA Lab Expands Our Early De-risking Capacity
Upcoming Conference PEGS Boston 2023, USA
New Whitepaper: Optimization of mRNA Manufacturing
Shaped Around You - Committed to your molecule’s IND
New Whitepaper: Late-Phase Drug Product Development and Launch
Biologics
Biologics
Modalities
  • Mammalian
  • Microbial
  • ADCs / Bioconjugates
  • mRNA / LNP
  • Drug Product
Technologies & Products
  • Expression Technologies
  • Discovery Products
  • Bioprocessing Products
Discovery and Preclinical
  • Early De-risking & Optimization
  • Cell Line & Strain Development
  • Process Development & Optimization
  • Analytical Development
  • Formulation Development
  • Non-GMP Manufacture
Clinical and Commercial
  • Process Development & Optimization
  • Formulation Optimization
  • cGMP Drug Substance Manufacture
  • cGMP Drug Product Manufacture
Back
Small Molecules
Small Molecules
Services
  • Drug Substance (API)
  • Particle Engineering
  • Drug Product
Technologies
  • Highly Potent API (HPAPI)
  • ADCs
  • Spray Dried Dispersions
  • Micronization & Jet Milling
  • Inhaled Delivery (DPI)
Solutions
  • Early Phase API
  • Commercial Production API
  • Bioavailability Enhancement
  • Integrated Offerings
Knowledge Center
  • Webinars
  • Presentations
  • Publications
  • Meet the Experts
  • View all
Back
Cell & Gene
Cell & Gene
Services
  • Process Development
  • cGMP Manufacturing
  • Regulatory Consulting
  • Bioassay Services
  • Tissue Acquisition
Modalities
  • Autologous
  • Allogeneic
  • Viral Vectors
  • iPSCs
  • Exosomes
Technologies
  • MODA® Platform
  • Cocoon® Platform
  • Nucleofector® Technology
  • TheraPEAK® Media
  • Endotoxin and Pyrogen Testing
Knowledge Center
  • Webinars
  • Articles
  • Whitepapers & Publications
  • eBooks
  • Presentations
  • View all
Back
Capsules & Health Ingredients
Capsules & Health Ingredients
Health Ingredients
Nutraceutical capsules
Pharmaceutical capsules
Capsule filling equipment
Back
Contact
Back
  • Home
  • Biologics
  • Mammalian Biopharmaceutical Services
  • Fabs, Fusion, Scaffold and Other Recombinant Proteins DNA-to-IND Program

Fabs, Fusion, Scaffold and Other Recombinant Proteins
DNA-to-IND Program

Realizing the potential of these next-generation molecules means finding appropriate expression technologies, analytical methods and development processes that can facilitate their path to market.
Talk to our experts
14-16* months from DNA to IND for fabs and fusion proteins.
15-18* months from DNA to IND for scaffolds and other recombinants proteins.
~40% of the large molecules we supported in 2021 are non-mAbs.
~45% of our non-mAbs are new molecular formats.

Our expression technologies and expertise help address challenges with new, more complex molecular formats

Antibodies still predominate in the clinic, however there is a large shift in drug development pipelines to more complex, next generation biologics, which often do not express well in current expression platforms.

We have decades of experience in developing and manufacturing novel molecular formats and other recombinant proteins, comprising approximately 40% of the large molecules our teams supported in 2021. This is achieved by leveraging extensive expertise and a breadth of innovative technologies, together with our proprietary GS Gene Expression System®.

To help you accelerate your path to the clinic, we offer integrated drug substance and drug product programs with the following typical timelines:

  • Fabs & fusion proteins: from DNA to IND in 14 to 16 months*
  • For scaffolds and other recombinants proteins: from DNA to IND in 15 to 18 months*

The technical scope and timelines for all programs can be tailored to your specific needs.

*Typical timelines. From DNA transfection. Subject to molecule evaluation.

Embrace molecule complexity 

Find out about our CLD enabling technologies

Related Offering

Ibex® Design | Standard mAbs DNA-to-IND Program
Benefit from our fixed price, fastest DNA-to-IND program that minimizes risk and uncertainty from...
Learn More
Bispecific Antibodies DNA-to-IND Program
We provide an integrated drug substance/drug product DNA to IND program with reliable timelines...
Learn More
Mammalian Cell Line Development
Benefit from our flexible approach to cell line development matching your project’s priorities in...
Learn More
Mammalian Process Development
We provide access mammalian cell culture process development, optimization and validation services...
Learn More
Mammalian Analytical Development
We provide analytical capabilities encompassing a wide range of technologies to support all stages...
Learn More
Mammalian Drug Substance Manufacturing
Our global biopharmaceutical mammalian manufacturing network offers a range of cGMP production...
Learn More
Parenteral Drug Product Formulation Development
We offer formulation development for all biologics modalities and dosage forms. Learn more.
Learn More
Drug Product Manufacture
We offer fully integrated biologics manufacturing services from selection and qualification of the...
Learn More
Biologics Regulatory Services
Partner with our dedicated biologics regulatory team to define the optimal regulatory strategy for...
Learn More
Biologics

Related Insights

Knowledge Center
Presentation (on-demand)
Embrace Molecule Complexity with Optimized Expression Technologies
Biologic drugs are increasingly complex, creating numerous challenges for biopharmaceutical...
Article
Small Biotech Success - Levicept
Levicept Founder and CEO, Simon Westbrook, discusses his experience in selecting and working with a...
Webinar (on-demand)
Tailored CMC solutions that meet the needs of novel molecular biologic formats
Antibodies still predominate in the clinic, however there is a large shift in drug development...
Knowledge Center

Latest news

View all Articles
29 Mar 2023
News Release
Lonza Completes Clinical and Commercial Drug Product Manufacturing Line in Visp (CH)
View Article
29 Mar 2023
News Release
Lonza Completes Clinical and Commercial Drug Product Manufacturing Line in Visp (CH)
View Article
29 Mar 2023
News Release
Lonza Completes Clinical and Commercial Drug Product Manufacturing Line in Visp (CH)
View Article
16 Feb 2023
News Release
Lonza Completes Expansion of Conjugation Facility in Visp (CH)
View Article
16 Feb 2023
News Release
Lonza Completes Expansion of Conjugation Facility in Visp (CH)
View Article
16 Feb 2023
News Release
Lonza Completes Expansion of Conjugation Facility in Visp (CH)
View Article
13 Feb 2023
Media Advisory
Lonza to Expand Early Development Services Offering into North America
View Article
13 Feb 2023
Media Advisory
Lonza to Expand Early Development Services Offering into North America
View Article
View all Articles
Ways to Contact
  • Contact Us
  • Regulatory Support
  • Locations
  • Partnering with Us
Resources
  • Knowledge Center
  • Meet the Experts
  • Upcoming Events
Terms & Conditions
  • Terms and Conditions
  • Legal Disclaimer
  • Privacy Policy
  • California CCPA Notice
  • Transparency in Coverage
Lonza.com
  • Company Overview
  • News & Media
  • Investor Relations
  • Sustainability
  • Careers
  • Sitemap
© 2023 Lonza. All rights reserved.