Biosimilar Drug Development – the analytical strategy is a keyfactor for your success The generation of analytical data for the comparison between a biosimilar and the originator product is the initial assumption in the development of biosimilars.

Achieving biosimilarity can be a controversial and complex topic when deciding the right time point and range of analytics. Protagen Protein Services (PPS) with 20 years of market experience in protein analytics and over 500 customer projects successfully completed, we guide you as your pilot and analytical service provider in your efforts, offering a stepwise approach to all aspects of analytical characterization combining structural, physical and functional data in order to provide a meaningful assessment of biosimilarity.

Effectiveness and Economic Efficiency

The effiency and longterm safety for a biologics are largely based on clinical studies that have already conducted. Any biosimilar development project aims at developing a product highly similar to the reference biologics. Having an analytical strategy to compare the physicochemical properties of a biosimilar to its reference product can therefore provide important clinical data to indicate that clinical similarity exists in safety and efficiency between reference product and biosimilar and streamline the development process. Changes in critical quality attributes (CQA) which can occur during the manufacturing process have to be tightly controlled and constantly balanced against the originator’s fingerprint. For a successful approval of biosimilarity, the worldwide authorities’ stringent requirements have to be met. Hence, in terms of effectiveness and economic efficiency it is advisable to set up and follow a comprehensive analytical strategy approach from an early stage on their way to regulatory approval.

At PPS, a team of more than 100 specialists focused on analytics is currently cooperating with 25 companies all over the world in the field of developing biosimilars. We work on a basis of mutual trust and reliability. Every client is unique, and so are our individual and well-tailored approaches at how to design a project set-up that fits your strategy.

Best Possible Understanding of the Originator

Knowing the reference product as thoroughly as possible is essential and an averse risk based approach for the development of a biosimilar. Physicochemical and functional biologic characterization are the biggest portions of the development. They are also the most complex challenges, beginning with the characterization of as many of the quality attributes of the originator as possible, and ending up with establishing the acceptable range of variation for each attribute that is considered to be critical. For the initial step we can provide the whole supply chain in worldwide originator sourcing, from single source to batch-to-batch, to make the reference product accessible for further analysis. PPS havs analyzed over 30 originators in the last year and set up a broad experience in analytical methods to characterize originators for further assessments.

The Process Defines the Product

The more profoundly your approach is designed, the better will be your understanding of the manufacturing process. Applying suitable methods as part of a comprehensive approach from an early stage on is the key. According to FDA and EMA guiding principles on how analytical tests should be performed to assess the analytical similarity or comparability between a reference product and a proposed biosimilar, PPS will be your perfect partner in supporting early selection and preliminary qualification steps.

We provide a broad set and combination of orthogonal analytical methods revealing structure-function relationships, delivering in-depth comparability information and allowing extrapolation towards non-measured attributes to compare the physicochemical and biological characteristics of the two products, in some cases down to the fingerprint level. The method set in able to cover the primary, secondary and higher order of protein structure; the purity and impurities; the post-translational modifications, such as glycan profiles. We have the capacities and the long-term experience to accompany complex biosimilar development projects by establishing the quality target product profile (QTPP), by applying forced degradation and using state-of-the-art methods to detect potential differences, and by evaluating molecules and processes according to tailored comparability exercises and regulatory standards.

The Equilibrum of Risks, Costs, and Quality

Developing a biosimilar product is a long-term process covering years and usually generating considerable costs. So much more it is worth considering risk minimization measures right from the start while maximizing solid results. Fixed budgets give you economic safety during our cooperation. With PPS as your consultant and partner you will benefit not only from our up-to-date expertise in characterization and testing methods but also from our worldwide network including sourcing companies and representatives of regulatory authorities in order to ensure good quality and to meet the valid standards for approval.

We will be happy to assist you with your project.

Protagen Protein Services GmbH

Don’t hesitate to contact us:

Ulrike Konrad, Business Development Manager

Phone: +49 (0) 231 9742-6100

Email: [email protected]