Clinical manufacturing services
End-to-end, fully compliant manufacturing services for biotech and pharma drug developers conducting clinical trials
At Thermo Fisher Scientific, we recognize the need for speed and reliability in clinical manufacturing. Our state-of-the-art facilities are equipped with advanced automation and innovative technologies to handle even the most challenging projects. Our comprehensive clinical manufacturing capabilities include microdosing of APIs and API blends, manufacturing of matching IMP placebo tablets, and over-encapsulation and blinding of parenteral drugs. Aligned with strict regulatory and quality guidelines, our services ensure compliance and consistency at every phase of your research studies.
Our clinical trial manufacturing capabilities
Clinical blinding of various packaging formats
- Pre-filled syringes, vials, bottles, nasal sprays, and IV bags
- Fully automated blinding of comparators via single- and multi-product over-encapsulation, including:
- Method development and validation
- Stability testing
- Data generation for release and IMPD submission
- Matching IMP placebo tablets, parenteral drugs, and over-encapsulation
Microdosing of API and API blends with Modu-C LS Containment (Harro Höfliger)
- Two Modu-C LS systems available, including one fully contained
- High-speed manufacturing of API in capsules, inhalation capsules, and matching placebos using Modu-C LS, featuring:
- 100% check-weighing of net weight per capsule via sensor control (advanced mass verification)
- Fully contained encapsulation for API doses as low as 1 mg
- Different dosing principals (e.g., drum dosing with sonication or with MicroVibe™ instruments)
- Processing of spray-dried powders and other low-flowability products using an ultrasonic dosing station
- Simplified and accelerated tech transfer and scale-up from clinical to commercial manufacturing
- Integrated in-process control based on weight
- Safe handling of hazardous materials
The site in Basel supports all aspects of the clinical trial supply chain—including primary and secondary packaging, labeling, regulatory support, distribution, returns and destruction, and comparator sourcing. Additionally, it provides cold chain supply management and in-house engineering for tooling, equipment customization, and product automation. The site also provides advanced capabilities in microdosing technologies, supporting the accurate formulation and delivery of ultralow drug doses essential for early-phase clinical development through commercialization.
The Allentown site is our largest ambient and cold packaging, storage, and distribution facility. The site has expanded its services to include commercial packaging with serialization, offering primary packaging of oral solid doses for blister packs and bottles, along with additional secondary packaging services for syringes, prefilled syringes, and pens—as well as autoinjector assembly and labeling.
The Horsham facility offers automated global distribution and integrated biologic product capabilities. It provides a comprehensive service line supporting all aspects of the clinical trial supply chain—including primary and secondary packaging, labeling, regulatory support, distribution, and returns and destruction.
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