Aseptic Fill & Finish

Stability Programs

At Althea, we can design, set-up, and manage stability studies that follow ICH compliant protocols. Our stability capabilities are in master and working cell bank characterization, method transfer and optimization, long-term stability studies, and accelerated stability studies.

With our comprehensive stability program capabilities, we can design, or help you design, a stability study that is appropriate for your protein and stage of clinical testing. This design includes everything from frequency of testing and choice of temperatures to identification of appropriate stability-indicating assays and stability-limiting product degradations.

PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.

QUALITY & REGULATORY
Taking pride in our history of quality.

Core Services

ICH Compliant Protocols

LIMS Stability Module

Method Transfer and Optimization

Accelerated Stability Studies

Storage Conditions

-70°C ± 10°C
-40°C ± 10°C
-20°C ± 5°C
5°C ± 3°C
25°C ± 2°C (60% RH ± 5% RH)
40°C ± 2°C (75% RH ± 5% RH)

Long-Term Stability Studies

Integrated
Value

Biologics Manufacturing

Forget about shipping valuable API from facility to facility and qualifying additional vendors. At Althea, after producing and formulating your API, we can readily fill your clinical or commercial drug product into vials or syringes. This means less product transfer, less cost, less time.
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Protein Analytics/
Stability Testing

At Althea, you have a leading analytical laboratory working with your product every step of the way, through development and production. This means more efficient product understanding and the ability to tune your process as your product advances. Learn More