How to accelerate biologics early development to IND with Quick to Clinic

Quick to Clinic™ is an integrated early development offering designed for biotech companies looking for a dependable solution to scale up recombinant antibodies from discovery to first-in-human (FIH) trials. With Quick to Clinic, you balance early development timelines, risks, and future scale-up and commercialization needs.

Speed up your early development to as little as 13 months from the start of transfection to IND with best-in-class technologies, allowing you to file faster and get to patients sooner. Enabled by:

Manage risk using a carefully constructed program backed by supply security from a company with broad technology portfolio and deep scientific expertise leading to an assurance that you don’t have to sacrifice quality for speed. Enabled by:

Focus on today’s challenges and let us prepare you for the future. Getting your molecule from discovery to IND faster is just the first step. A high-yield expression system and robust process platform prepare you for long-term commercialization success. Enabled by:

A robust platform and trusted cell line

A critical aspect of any early development work is the cell line that underpins the platform process. Quick to Clinic leverages Gibco™ Freedom™ ExpiCHO-S™, an in-house cell line targeted to deliver antibody titers in the 3-5 g/L range. The Gibco Freedom ExpiCHO-S expression system provides a modernized and miniaturized 4-5 month cell line development timeline to final clone selection, cGMP host cells banked in chemically defined media free of any animal-derived components, and a licensing program with no royalty payments or exit, quickly setting you up for long-term success.

WHAT YOU PROVIDE

Starting material: Gene

  • DNA sequence – genetic code

WHAT WE USE

  • Thermo Fisher Scientific Gibco™ Freedom™ ExpiCHO-S™ Platform
  • Patheon pharma services’ platform process and Thermo Fisher media/feeds with commercially available raw materials

WHAT WE DO

Drugs affecting the immune system’s response to an infection by either turning up or down the immune system’s response.

  • Cell Line Development using Berkeley Light Beacon® System
  • Evaluation of upstream and downstream platform process using high throughput automation technologies such as ambr® 15 microbioreactor & Tecan miniaturized purification platform
  • Formulation screening
  • Analytical method establishment & qualification
  • Toxicology batch
  • cGMP batch: 500L – 2000L
  • Viral clearance study
  • Stability testing

WHAT YOU GET

Drugs affecting the immune system’s response to an infection by either turning up or down the immune system’s response.

  • Early toxicology material
  • Released drug substance
  • Released drug product
  • Minimum 1-month stability data for IND
  • Templated qualityreviewed reports
  • Clinical trial packaging and labeling (optional)
  • Regulatory CMC dossier for IND/IMPD filing

Learn more about accelerating your development time

Additional Resources