CMC ANALYTICAL SUPPORT

CMC Analytical Testing Services

cGMP Lot Release Testing

Extensive Experience

Scorpius' highly skilled analytical method development scientists and QC analysts have years of experience, working across many types of products and analytical technologies to ensure that test methods are fit for purpose. Our expertise spans a variety of molecules and formulations. We offer a comprehensive range of analytical testing services for the characterization of complex biologics, vaccines, and advanced therapies.

Range of Analytical Methods

A variety of analytical methods are available including compendial and client specific/custom assays. Our laboratories are equipped with sophisticated analytical technologies including HPLC, spectroscopy, flow cytometry, Biacore^™, Luminex^®, Isoplexis and fluorescent microscopy. Working with us, you gain an experienced partner with knowledge of phase appropriate method qualification and validation requirements suited to the pace of development.

With QA oversight, our product characterization and QC release testing services provide cGMP-compliant testing programs designed to ensure the safety of your biopharmaceutical while keeping timelines on track.

Lot Release Testing Capabilities:

Sterility or bioburden
Endotoxin
Mycoplasma
Adventitious virus testing
In vitro and in vivo virus screen
Retrovirus testing
Product titer/concentration
Product identity
Product purity
Product potency
Residual DNA
Host cell protein
Process residuals

Product Stability Testing

Meeting ICH Requirements

Scorpius' state-of-the-art contract analytical laboratory provides biopharmaceutical stability testing and stability storage conditions that meet ICH requirements for stability studies, shelf-life testing, and shelf-life determination. We conduct stability studies following client-supplied methods, compendial methods or methods that have been developed and validated by our own analysts.

Validated & Continuously Monitored Storage

Our stability storage chambers are fully validated and controlled using a validated, continuous monitoring system. The chambers and monitoring system are supported by external back-up power generators that mitigate any power failure. Stability programs are conducted under cGMP and ICH guidelines, and individual assays can be run under cGMP conditions with QA oversight. Regardless of the type of biological product, we can design and implement comprehensive product stability testing and storage programs to meet regulatory and client requirements.

Real-Time & Accelerated Stability Testing

Shelf life is commonly estimated using results from both real-time stability and accelerated stability tests. In real-time stability testing, a product is stored at recommended storage conditions and monitored until it fails product specifications. In accelerated stability testing, a product is stored at elevated stress conditions (e.g., high temperatures and/or humidity). Degradation at the recommended storage conditions can then be predicted using known relationships between the acceleration factor and the degradation rate. Forced degradation studies are particularly useful in early product development to optimize the formulation, determine the optimal storage conditions and maximize product stability.

Stability Testing Capabilities:

Real-time stability

Accelerated stability

Forced degradation studies

Long-term stability

Services