Contractors Support Material Testing

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Materials used in the formulation and manufacture of drug products must meet certain qualifications, as do the companies that manufacture these materials. Contract development and manufacturing organizations (CDMOs), contract testing laboratories (CTLs), and contract manufacturing organizations (CMOs) can assist sponsor companies with the testing of these crucial drug components. Testing may include analytical testing, impurities testing, and qualification services.

According to Iain McGhee, vice-president of Quality at Ascend Advanced Therapies, contract organizations can provide proprietary and sourced analytics and assays as standalone services or included in a complete program. “Regardless of who you work with, CMO/CDMOs should be able to provide suggestions on a range of testing depending on the customer program,” says McGhee. “If they do not offer this in house, they should have validated partners to do this with.”

Contractors can either do the testing or work with other, outside testing facilities to perform testing on raw materials to ensure compliance with specifications and standards. At Andelyn, according to Rajiv Vaidya, head of MS&T, the company uses a two-phased approach to raw material testing. The process is performed in-house as much as possible to keep everything streamlined. “We have a program in place to continuously evaluate and in-source as much material testing as possible,” says Vaidya. “There is a sweet spot to understanding the balance between what should and should not be done in house—it depends not only on speed and cost but what is the best or most excellent provider for any given test, whether outsourced or in-house. We will only in-source a testing method after we’ve confirmed definitively that the methodology and result will be at least equivalent to the CTLs.”

Testing materials

Determining how to test bio/pharmaceutical materials depends on the API, the dosage form, and the stage of the material, according to Mayank Nagar, vice-president and head–Tech Services and New Product Launches, North Americas at Dr. Reddy’s Laboratories, and Himanshu Joshi, director, New Product Launches, North Americas at Dr. Reddy’s Laboratories. Testing may be performed from pre-formulation through packaging and life-cycle management, say Nagar and Joshi.

Contract organizations can provide custom material testing services for a sponsor company’s needs, including identity tests, purity tests, assays, polymorph testing, and compatibility testing, say Nagar and Joshi. “Various physicochemical testing [such as] dissolution, particle size, description, density, LOD are routinely being serviced by CMOs. Additionally, safety, sterility testing, microbiology, and confirmatory testing are other services provided to sponsor companies,” they say.

CDMOs can also provide final product release testing, according to Kim Arsenault, Quality Compliance manager, BIOVECTRA, such as the following:

• using high-performance liquid chromatography (HPLC) to provide assay and impurity content utilizing ultraviolet (UV), charged aerosol (CAD), or mass spectrometry (MS) detectors
• testing for residual solvents by using gas chromatography (GC)
• performing Karl Fischer (KF) titration to test water content
• detecting elemental impurities by using inductively coupled plasma with mass spectrometry (ICP–MS) or optical emission spectroscopy (ICP–OES)
• microbial limits and bacterial endotoxins testing
• performing identity testing using chemical techniques or infrared (IR) spectroscopy
• performing enzyme-linked immunosorbent assay and sodium dodecyl sulfate-polyacrylamide gel electrophoresis biochemical methods
• testing for compendial compliance of pH, optical rotation, and loss on drying
• performing gravimetry, titrimetry, and colorimetry bench techniques.

Production stage and the grade of materials used matters, according to McGhee. “Ironically, a lower grade of material with impurities can sometimes makes results look better. However, these results will not scale as the grade tightens—we need to know this early on,” he cautions.

Conclusion

Utilizing CMOs and CDMOs to perform the necessary analytical and quality testing of raw materials used in the production of bio/pharmaceutical products can ensure that these medicines are safe and effective for patients. Contract organizations typically have the knowledge, expertise, and equipment to perform the necessary testing.

“Generally, CMOs/CDMOs should be able to perform the tests outlined for characterizing APIs as listed in ICH [International Council for Harmonisation] Q6A, including characterization of physicochemical properties (e.g., pH, melting point/range, IR), particle size determination, polymorphic form, assay and impurity testing (including tests for chirality, identification tests, residual water content, residual solvents, inorganic impurities), and microbial limits (if applicable),” says Joshua Hoerner, general manager and executive vice president, Purisys (part of the Noramco Group). “It is also important to have hyphenated or specialized techniques [such as] LC–MS, GC–MS, LC–CAD/LC–ELSD, and NMR [nuclear magnetic resonance] for investigative or characterization purposes, should a sponsor’s product experience unexpected results during release or stability testing,” he concludes

About the author

Susan Haigney is lead editor with BioPharm International®.

Article details

BioPharm International®
Vol. 37, No. 9
October 2024
Pages: 32–33

Citation

When referring to this article, please cite it as Haigney, S. Contractors Support Material Testing. BioPharm International 2024 37 (9).