QUICK TO CLINIC™
The pressure to file an IND makes accelerated Phase I safety testing a priority. Our novel Quick to Clinic programs for small and large molecules deliver your small and large molecule with speed. Now you can meet important milestones – such as filing the IND – or secure additional funding with all the confidence your project needs and, we can supply. Because helping you reduce the time it takes to get your discovery to the patients who need it matters, our Quick to Clinic for programs are made with speed and flexibility.
Small Molecule & Oral Solid Dose (OSD) Quick to Clinic™ Program
In as little as 14 weeks from receiving your small molecule API, you can have your Phase I drug product manufactured, labelled, packaged and delivered to the clinic. That’s 1 month faster than most standard timelines, and includes a one-month stability study. Plus, you now have access to five dosage forms:
- Blend in bottle
- API in bottle
- Softgel capsules
- Blend in capsule
- API in capsule
Benefits of our Small Molecule & OSD Quick to Clinic™ Program
- Speed is important, but consistent high quality is a must – Our regulatory and RFTIT/OTD (Right First Time in Full/ On-Time Delivery) performance are second to none.
- All the data you need – With 1-month stability studies, you’ll have the data you need to make informed proof of concept decisions and to complete your regulatory submissions.
- Unmatched capabilities and experience – Meet the unique needs of your molecule and business with expansive resources and the experience of thousands of projects.
- Lay the foundation for commercial success – You’ll establish a clear path that could take you all the way to commercial success. Reach your milestones faster. Never compromise quality.
Large Molecule Quick to Clinic™ Program
In as little as 14 months, you can have your released biologic drug product ready for your Phase I, First-in-Human trial. That’s six months faster than most standard timelines and includes a minimum of one month of stability data. This innovative program for biologic molecules provides you with:
- Cell line development (optional, not required)
- Cell culture and purification processes
- Liquid-filled vial drug product formulation
- Analytical methods
- Early non-GMP material for toxicology studies
- Released GMP drug substance
- Released GMP drug product
- Viral clearance and stability study data
Benefits of our Large Molecule Quick to Clinic™ Program
- Fast: released drug product in as little as 14 months, which is enabled by our:
- Platform cell culture and purification processes
- Automation: Beacon, ambr® 15, and Tecan systems
- Integration of drug substance and drug product timelines where work is done in parallel
- Pre-qualification of common vials
- Templated, QA-reviewed documentation
- > 45 years of experience with similar programs
- Flexible: we will work with your cell line, our cell line, or a third-party’s cell line:
- We give you the flexibility to work with your cell line and media, a third party’s, or our own.
- Your process is not tied to proprietary media
- Our Gibco™ Freedom™ CHO-S™ cell line is free from royalties and annual fees – there is a simple one-time fee for a single or multiple molecules
- With the Freedom CHO-S cell line, you have the ability to transfer or sell the molecule without any additional fees
- The Freedom CHO-S cell line is well established and fully documented
- Full: you get a comprehensive solution to support your IND submission and Phase I trial:
- Cell culture process screening
- Complete cell line document (Freedom CHO-S only)
- Drug product formulation screening
- Sufficient material for toxicology studies, viral clearance studies, and retains
- Released drug product with a minimum of one month of stability data
- Optional clinical packaging and labeling solutions
- Optional cold chain storage and distribution
Nobody can get you to Phase I clinical trials faster with more dosage forms, higher quality and a drug product with more built-in value than Patheon, by Thermo Fisher Scientific.