Analytical Testing to Support Biopharmaceutical Products - Due to their complexity, biopharmaceuticals require a vast array of testing using orthogonal techniques. - BioPharm International


Analytical Testing to Support Biopharmaceutical Products
Due to their complexity, biopharmaceuticals require a vast array of testing using orthogonal techniques.

BioPharm International

During these various phases, cell line selections, cell culture processing, harvesting, and purification are all studied and optimized. GMP regulations require that these processes be validated. Therefore, assays must be developed and large amounts of data must be collected on critical parameters such as purity, contamination, degradation, etc.

Cleaning Validation

Cleaning validations may also be carried out on equipment, surfaces, etc., to check for residual detergents, product, or microorganisms. In many cases, a simple, nonspecific assay such as total organic carbon (TOC) can be used. However, in other situations, specific analyses (one that can determine the concentration of a specific chemical) are performed using HPLC. Moreover, an increasing number of applications that use single-use or disposables, such as filters, tubing, and bags for biopharmaceuticals can introduce unwanted extractables into the final product. The qualification and quality control of all components coming into contact with the drug formulation has become an integral part of any FDA application process.

Process Validation

Process validation is a legal requirement in the industry to demonstrate through appropriate testing and documentation that the finished biopharmaceutical produced by a specified process meets all release requirements for quality. Successful process validation requires thorough process development, identification of controlled and critical parameters, and establishment of specifications throughout the process. A minimum of three consecutive lots of product meeting the established quality specifications is necessary to validate a process. Many of the tests described here are used during process validation. These validations may entail collection and testing of large volumes of samples.

Stability and Release

Table 4. Ongoing stability and release tests like these are conducted after drug approval.
Once the drug is approved there will be ongoing testing to support stability and release of the product. This typically covers critical parameters such as characterization, identity, concentration, purity, excipient testing, potency, sterility, and safety. An example of a specific testing matrix is shown in Table 4.


In conclusion, an enormous amount of analytical testing is required to support a biopharmaceutical product throughout its lifecycle, from discovery and early development through stability and release testing. Due to their complexity, an extensive number of methods are required to fully characterize them. Many biopharmaceutical organizations may need to consider outsourcing portions of their analytical testing to remain competitive.

Jon S. Kauffman, PhD, is the director of Method Development and Validation and Biopharmaceutical Services at Lancaster Laboratories, Lancaster, PA, 717.656.2300,

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