Bioanalytical Services

CMC Analytical Support Services

The production of cGMP-grade biologics demands that a product’s manufacturing processes, characteristics, and analytical test methods be well-defined to ensure that the product is safe, effective and consistent between batches. These activities, known as CMC (chemistry, manufacturing and controls) are required by global regulatory agencies throughout product development.

The analytical testing package supporting CMC has elements that require comprehensive capabilities and specialized expertise, requiring operation within a cGMP-compliant quality management system.

The experts at Scorpius not only understand the process from the initial research stage through to cGMP manufacturing, but are also knowledgeable in global regulatory guidance and requirements as well as the utilization of “phase-appropriate” cGMP compliance methodologies. The FDA and other global regulatory agencies collectively support regulatory flexibility for early-phase manufacturing and testing of advanced therapies including cell and gene therapies, protein therapeutics and vaccines. A phase-appropriate approach reduces the cGMP compliance burden during clinical development and facilitates a faster route to early-phase clinical studies.

Scorpius offers CMC analytical testing support for both cGMP product release testing, as well as product stability programs conducted under cGMP and ICH guidelines.


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, and 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 product-specific or custom assays. Our laboratories are equipped with sophisticated analytical technologies. By 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 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

The types of lot release testing available from Scorpius include:

  • Product titer/concentration
  • Product identity
  • Product purity
  • Product potency
  • Process residuals
  • Product safety


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 potential 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 client and regulatory 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 product formulation, determine optimal storage conditions and maximize stability.

Stability Testing Capabilities:

Real-time stability
Accelerated stability
Forced degradation studies
Long term stability