The long-term safety and efficacy of biosimilars are largely based on clinical studies that have already been conducted on the reference biologic, but these studies may not always be sufficient to ensure that the biosimilar can comparably replace the reference product. Having an analytical strategy can provide important clinical data to indicate similarity between a biosimilar and its reference product. 

spoke with Patricia Hurley, PhD, senior director, Regulatory Consulting, and Duu-Gong Wu, PhD, senior director, CMC/Regulatory Consulting, both at PPD Consulting and Edward Tabler, associate director, PPD Laboratories’ bioanalytical lab, to gain insight into the impact that analytical testing on biosimilars has on their pathway to regulatory approval.

	When referring to this article, please cite it as F. Mirasol, "An Analytical Approach to Biosimilar Drug Development," 

BioPharm International Biopharma Laboratory Best Practices 

Articles

Features

Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.

An Analytical Approach to Biosimilar Drug Development

spoke with Aled Jones, senior product and applications manager at ProZyme; Philip Widdowson, European application development scientist at Thermo Fisher Scientific; and Dr Daryl Fernandes, chief executive at Ludger Ltd, about best practices for performing glycan analysis.


	Vol. 31
	October 2018
	Pages: 12, 14, 16–17

	When referring to this article, please cite it as S. Haigney, "Glycan Analysis Best Practices," 

Experts discuss best practices for performing glycan analysis.

Glycan Analysis Best Practices

Because the raw materials used in biologic drug development can impact drug interaction and patient safety, the testing of raw materials is necessary to ensure quality. 

spoke with Roisin Browne, site manager at Almac Sciences’ analytical services site in Athlone, Ireland; Andrew Bulpin, head of Process Solutions at MilliporeSigma; and Erik Foehr, PhD, vice-president, Analytical Sciences, at Pacific BioLabs to discuss best practices for analytical testing techniques and instrumentation used for raw materials testing.

	When referring to this article, please cite it as F. Mirasol, "Analytical Best Practices for Raw Materials Testing," 

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

Analytical Best Practices for Raw Materials Testing

About a decade ago, FDA and other regulatory agencies introduced a series of pharmaceutical guidance documents that included risk management and quality by design (QbD). These initiatives were aimed at modernizing the manufacturing of small-molecule drugs and biologics. The topics on risk management and QbD were published as International Council for Harmonization (ICH) guidance Q9 (1) and ICH guidance Q8 (2), respectively. Both concepts have

	been widely accepted by the industry within the manufacturing space and have been applied effectively to minimize production failure risks and define a design space where quality target product profiles can be managed and maintained.

	The pharmaceutical analytical community, unfortunately, has been rather slow in adapting these concepts, as well as design of experiment (DoE) (3), for in-process testing or release and stability assessment of drug substance and drug product. In this paper, the author outlines the reasons why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.

	Mario Dipaola is senior scientific director at Charles River Laboratories, Woburn, MA.

	When referring to this article, please cite it as M. DiPaola, "Best Practices in Analytical Method Development and Testing," 

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.

Best Practices in Analytical Method Development and Testing

Proteins must be characterized at many phases of biopharmaceutical research, development, and manufacturing, each with differing demands and requirements. Instrument capabilities-and limitations-influence the speed and success of development efforts. Researchers from biopharma, contract service organizations, and academia face challenges of selecting and optimizing appropriate techniques for protein characterization needs.

 shared similar concerns about the need to conduct complex protein characterization studies under the pressures of tight timelines and urgency to get new drug products to clinic and approval.

	When referring to this article, please cite it as R. Peters, "Complex Protein Studies Demand Dynamic Techniques," 

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

Complex Protein Studies Demand Dynamic Techniques

Contract research, development, and manufacturing organizations (CRO/CDMOs) are well established in the drug development lifecycle and are often used for dedicated activities along the drug discovery and preclinical development process. Each of these main areas (discovery and development) of the drug development process breaks into specific areas. These areas can include target identification, target validation, lead identification, early pharmacology, high throughput screening (HTS), adsorption, distribution, metabolism, and excretion (ADME), drug metabolism and pharmacokinetics (DMPK), bioanalysis, formulations, safety/toxicity, process development, and scale up, etc. Domain specialist CROs have emerged in this space as well as larger “platform” CROs who offer full “end-to-end” service.

	The shift to large molecule/biologics as drug candidates has been occurring for the past 10–15 years (1)-the trend often attributed to the success of Herceptin, Genentech’s blockbuster treatment for certain types of breast cancer. Many pharma and biotech companies have looked to mimic this success, as evidenced by the increase in new drug applications for biologic-based drugs, year-on-year for 10 years. As companies rapidly change their focus, they may lack the laboratory space, instrumentation, and often, the scientific domain knowledge to support biologics research without a huge resource investment.

Biopharma Laboratory Best Practices 2018 

	Paul Denny-Gouldson is vice president of Strategic Solutions at IDBS.

	When referring to this article, please cite it as P. Denny-Gouldson, "Barriers and Solutions to Effective External Collaboration in Biopharma," 

As biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.

BioPharm International-10-15-2018

An Analytical Approach to Biosimilar Drug Development

Glycan Analysis Best Practices

Analytical Best Practices for Raw Materials Testing

Best Practices in Analytical Method Development and Testing

Complex Protein Studies Demand Dynamic Techniques

Barriers and Solutions to Effective External Collaboration in Biopharma