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Quick to Clinic: Your accelerated path to IND for biologics development

Thermo Fisher Scientific’s Quick to Clinic™ platform is a comprehensive solution designed to help expedite biologics development. This innovative service integrates advanced technologies and expert guidance to streamline the path from discovery to clinic and help ensure your biologics can reach patients faster.

What is the Quick to Clinic platform?

The Quick to Clinic platform is a specialized solution that combines Thermo Fisher’s extensive experience in biologics development with cutting-edge tools and methodologies. This dependable solution is tailored to scale up recombinant antibodies from discovery to first-in-human (FIH) trials, and offers a seamless, end-to-end solution that provides you:

  • Accelerated process development: Rapidly optimize your biologic production processes with our state-of-the-art platform.
  • Flexibility: Starting from either a gene sequence or a research cell bank, the Quick to Clinic platform offers options tailored to your specific needs.
  • Regulatory support: Benefit from our deep understanding of regulatory requirements to help ensure compliance and mitigate risks.
  • Preclinical manufacturing: Assured high-quality and regulatory compliance during cell line development, production, and toxicology testing.
  • Analytical testing: Comprehensive testing services to help ensure the safety, purity, and potency of your biologics.
  • Performance analysis: Multi-attribute method (MAM), leveraging liquid chromatography-mass spectrometry (LC-MS), to obtain glycan profiling, purity, and charge variant data.

Quick to Clinic platform timeline and options

Options
Timeline
What you provide
What we use
What we do
What you get
Option 1
DNA to drug product (DP) release in as few as 12 months*
DNA sequence/gene
Transposase technology in CHO-K1 GS knockdown cell line system, and platform process, formulation, and analytics with commercially available RMs.
Cell line development

Early non-GLP toxicology material

Released drug substance

Released drug product

Stability data for IND

Templated quality-reviewed reports

Clinical trial packaging and labeling

Option 2
Research cell bank (RBC) to drug product (DP) release in as few as 13 months*
RCB of stable pool or final clone

Your cell line RCB, media/feed strategy*, and cell stability data.

Our platform process, formulation and analytics development.

Evaluation of our platform process

Platform formulation

Analytical methods

Toxicology batch

cGMP batch at any scale

Validation and characterization study

Stability testing

Options
Timeline
What you provide
What we use
What we do
What you get
Option 1
DNA to drug product (DP) release in as few as 16 months*
DNA sequence or gene
Transposase technology in CHO-K1 GS knockdown cell line system, and our platform processes and analytics with commercially available raw materials.
Cell line development

Early non-GLP toxicology material

Released drug substance (DS)

Released drug product (DP)

Stability data for IND

Templated quality-reviewed reports

Clinical trial packaging and labeling

Option 2
Research cell bank (RCB) to drug product (DP) release in as few as 15 months*
RCB of stable pool or final clone

Your cell line RCB, media/feed strategy*, and cell stability data.

Our platform processes and analytics with commercially available RMs.

Evaluation of our platform process

Formulation development

Platform analytical method

Custom analytical method development

Toxicology batch

cGMP batch at any scale

Validation and characterization study

Stability testing

Why choose the Quick to Clinic platform?

Thermo Fisher’s Quick to Clinic platform is designed to address the unique challenges of biologics development. A critical aspect of any early development work is the cell line that underpins the platform process. This solution leverages transposase-based technology in CHO-K1 GS knockdown cell line, a commercial-ready cell line capable of delivering antibody titers up to 8 g/L.*

Speed to market

Helps to reduce development timelines and accelerate your biologic’s journey to clinical trials with innovative technology, giving you a competitive edge.

 

Robust cell line

Commercial-ready CHO-K1 GS knockdown cell line capable of delivering antibody titers up to 8 g/L.*

Expertise and support

Leverage our global network, team of seasoned professionals, industry-leading technologies, and state-of-the-art facilities to help overcome development challenges.

Global network of experts and facilities from development to drug product readiness
 

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Biologics
Capabilities of the Quick to Clinic platform
St. Louis, MO, USA
Groningen, NL
Cell line development
 
Process development
 
Analytical and formulation development
 
Preclinical scale production
50–250 L
 
Clinical scale production
 
500–2,000 L

Figure 1. Capabilities of the Quick to Clinic platform. Cell line development through clinical scale production process development, as well as analytical and formulation development, are completed at our state-of-the-art facility in St. Louis, Missouri. The process is then transferred to the Groningen, Netherlands facility for clinical scale production up to 500–2,000 L, and lastly moves to the Monza, Italy site for sterile fill-finish.

* Terms and Conditions: Titer levels provided are estimates based on third party results and may vary depending on molecule type or other factors. Timeline from DNA to drug product for all Quick to Clinic platform options may vary depending on molecule type or other factors and are estimates to be finalized after third party cell line development dates are available and confirmed.

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