NEW!
Steriles Express solutions for drug product development
Start strong. Finish fast.
Need a first clinical batch or preparing for late-stage clinical trials?
Thermo Fisher Scientific’s new Steriles Express early development and tech transfer solutions help you get there—faster.
Every day counts in drug development. Delays can put investor funding, critical milestones, and patient access at risk.
Our Steriles Express solutions are designed to compress timelines for early sterile development and technology transfer, helping you move efficiently from development through clinical supply with contractual timeline commitments and shared execution risk via a pay-for-performance model.
Why choose our Steriles Express solutions?
Get your first clinical batch for Phase I or Phase II in as little as 20 weeks* or transfer your late-phase program to Thermo Fisher in just 26 weeks*.
If we don’t meet our committed timeline, we pay you back.
Backed by a robust global network, a strong regulatory track record, and continued investment in innovation, we have a proven track record of success.
Explore the details of our Steriles Express solutions
Steriles Express Early Development
first clinical batch in 20 weeks*
Program components:
Applies to liquid formulations in 2R, 6R, 10R, and 20R vial sizes, with batch sizes of up to 10,000 units.
- Analytical services
- Microbiology
- Laboratory-scale batch manufacturing
- Technical documentation
- Phase I or II CTM batch manufacturing
Final deliverable: GMP clinical batch delivered within 20 weeks* from project kick-off
Timeline guarantee: We will pay back 1% after the first two weeks of delay, plus 1% per additional week, up to 5% total
Optional add-on services (not included in the timeline guarantee):
- CCI (method evaluation)
- Assay and related substances by SEC or HPLC (method evaluation, method transfer, or Phase I/II validation)
- DS identification by cIEF
- Product-contact parts compatibility
- Stability studies on laboratory-scale batches
- Fill volume qualification
- Stability studies on Phase I or II CTM batches
Participating sites: Monza, Ferentino, Plainville
Steriles Express Tech Transfer (TT)
Phase III CTM batch in 26 weeks*
Program components:
Applies to liquid formulations in 2R, 6R, 10R, and 20R vial sizes, with lot sizes of up to 10,000 units.
- Analytical services (protein concentration by SoloVPE or UVA280; method evaluation, transfer, or Phase I/II validation; cleaning residuals assay)
- Microbiology
- Laboratory-scale batch manufacturing
- Product-contact parts compatibility studies
- Filter validation studies
- Technical transfer documentation
- Phase III CTM batch manufacturing
Final deliverable: GMP Phase III clinical batch delivered within 26 weeks* from project kick-off
Timeline guarantee: We will pay back 1% after the first two weeks of delay, plus 1% per additional week, up to 5% total
Optional add-on services (not included in the timeline guarantee):
- CCI (method evaluation)
- Assay and related substances by SEC or HPLC (Phase III validation)
- DS identification by cIEF
- GMP feasibility batch
- Stability studies on GMP feasibility-scale batches
- Fill volume qualification
- Stability studies on Phase III CTM batches
Participating sites: Monza, Ferentino, Plainville
*Actual timeline may vary and is a good faith estimate based on best available data. Timeline begins on Thermo Fisher’s kick off meeting and ends on release of CTM by Thermo Fisher.
Start strong and finish fast with Steriles Express.
Contact a Thermo Fisher Scientific representative to learn how Steriles Early Development Express and Steriles Tech Transfer (TT) Express can help speed up your program—and determine which solution is right for your development needs.