CASE STUDYUNITED
WITH
STRENGTH & PURPOSE

Delivering a large-scale product at a rapid pace
Challenge
When a pharmaceutical client needed to introduce, manufacture, and validate five stages of challenging chemistry to support aPhase III clinical development program, the Thermo Fisher Scientific pharma services team had to get to work. Speed, scale, andcomplexity immediately became the hallmarks of this project.
The team had to:Complete the tech transfer,clinical manufacture,validation, and commercial
manufacture of API under
accelerated timelines

Manufacture at least
4.5MT of clinical API
within 7 months

Complete successful
validation of a five-stage
process with 12MT of API
shipped within 12 months

Delivering an accelerated program to support the client’s ambitious timelines for market authorization was no small feat for thisteam. Deploying 28 technical experts, the pharma services team developed a project plan to ensure rapid startup.

Solution
Upon mobilizing chemists, engineers, analysts, and a dedicatedprogram manager, the technical teams adapted at speed toaccommodate the numerous process and analytical changes
required across the five stages of chemistry. To meet production
startup dates, they completed significant site engineering andequipment modifications, along with recruitment and training
to ensure adequate resources to support the project.

Mobilizing the rightexpertise, with detailed
planning to act with agility

The supply chain team led a thorough and rigorous crossfunctional planning program that included detailed end-to-end
materials and tracking, batch production, intermediate and
API testing, release, and shipment. In turn, a high volume of
documentation supported production across multiple modules
running simultaneously.

Phase-appropriate
systems approach

Project timeline:Month 1Month 2Month 3Month 4Month 5Month 6

Month 7Month 8Month 9Month 10Month 11Month 12Month 13Month 14Month 15

Initial client contact and scoping
Project kickoff
Construction/equipment modifications: 5 x steps for 8 modules
Source, deliver, test, and release materials: 5 x steps
Analytical method transfer/development: 5 x steps
Technical transfer: 5 x steps
Step 1: Clinical manufacturing
Validation/commercial manufacturing
Step 2: Clinical manufacturing
Validation/commercial manufacturing
Step 3: Clinical manufacturing module #1
Validation/commercial manufacturing module #1
Clinical manufacturing module #2
Validation/commercial manufacturing module #2
Step 4: Clinical manufacturing
Validation/commercial manufacturing module #1
Clinical manufacturing module #1
Validation/commercial manufacturing module #1
Step 5: Clinical manufacturing module #1
Clinical manufacturing module #2
Validation/commercial manufacturing module #2
QC test/release intermediates/APIFirst API shipped
5 Stages validated across 8 modules
8T API shipped

Results
Manufacture of the first stage of clinical API commenced 12 weeks from project kickoff and ramped up quickly, with 6 modules(~50% of site capacity) brought into production within 7 weeks.
Within 13 months, the pharma services team manufactured:

8.5MT of clinical-grade API

4.5MT of commercial API

Thermo Fisher’s pharma services team met the client’s timelinedemands and delivered large-scale validated product rapidly
and reliably.

Successful pre-PAI
inspections to support
accelerated regulatory
timelines

Successful validation & execution offive stages of chemistry acrosseight production modules“The team is very flexible and responsive to ourrequests, engages well, and shows great availability
and good cooperation. We have access to anexperienced and skilled Thermo Fisher Patheonteam, and there is continuous learning from batch tobatch. This is a good partnership. The team has thewillingness and capability to change report templates
to reflect our needs and to introduce additional
controls in the lab for in-process methods. I’m also
impressed with the thorough root cause analysis
investigation and good track record on RFT.”—Pharmaceutical client+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com© 2022 Thermo Fisher Scientific Inc. All rights reserved.
Published 08/22