Quick to Clinic -Large Molecule Biologics Development Services
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:
- Use of platform cell culture and purification processes and analytical methods
- Careful construction and parallelization of drug substance and drug product activities
- Deploying high throughput automation technologies like Beacon® Optofluidic System, ambr® 15 and 250 microbioreactors, Tecan miniaturized purification system, and LC-MS based multi attribute methodology for characterization
- Streamlining of drug substance and drug product handover activities and pre-qualification of common vial formats
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:
- Avoiding high-risk activities such as using stable pool material for the tox batch, or use of modular viral clearance studies
- Templated, pre-prepared documentation (e.g. development reports, technology transfer protocols, etc.)
- Drawing from > 30 years of expertise developing over 100 recombinant protein products
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:
- Using a template platform process based on strong Process Development experience with > 80 PD programs completed since 2017
- Leveraging the Gibco™ Freedom™ ExpiCHO-S™ cell line with no royalty payments
- Drawing on a strong commercialization experience successfully handling >20 late-phase, pivotal study, commercialization programs from 2015 and >16 completed PPQ campaigns from 2017
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
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
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.
Starting material: Gene
- DNA sequence – genetic code
- Thermo Fisher Scientific Gibco™ Freedom™ ExpiCHO-S™ Platform
- Patheon pharma services’ platform process and Thermo Fisher media/feeds with commercially available raw materials