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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:

Outsourcing as a Key Strategy to Lower Your Costs and to Accelerate Your Product’s Launch

What makes a good partnership? Passion? Common goals? Complementary qualities? Protagen Protein Services provides it all. We offer you a strong, supportive partnership, allowing you to focus on your core competencies.

Biopharmaceutical companies are facing a growing complexity by expanding their drug development pipelines.

Get a Partner on Board

In the challenging world of biopharmaceuticals development, companies are required to become more efficient. Massive growth in pharmaceutical industries and in global emerging markets, combined with price pressure and increased development spendings, have increased the demand for outsourcing partners. Outsourcing support is the key not only to lower your costs in research, development and manufacturing, it also enlarges your scale of know-how, equipment and experience from your partners. Relying on our project leaders you will benefit in all aspects of your project: proactive communication, primary point of contact, planning and coordination of work and discussion of results.

Stay Focused

Outsourcing projects to PPS as a Contract Research Organisation (CRO) allows you to focus on your core competencies while we focus on analytical excellence for our customers. With more than 20 years of experience PPS have a long proven track record in protein chemistry and protein analytics, from which you as our client will benefit from. Based on current and currently evolving technologies, we are providing support across a broad range of specific activities, including characterization, stability and comparability testing, bioanalytical and release testing. Our experts are contributing their knowledge of instrumentation and software, a deep understanding of data processing and data interpretation, and their long-term and up-to-date expertise with regard to release requirements. Auspicious conditions for along-term partnership, ensuring cost efficiency and best possible development and testing processes at the same time for your company.

One-for-all Solution – cost-effective, individual, sustainable

Strategic and therefore longterm partnerships with CROs, rather than outsourcing single analytical assays, increases efficiency in communication, planning and performance. A strategic multi-year partnership helps reducing expensive tech transfer, saves internal resources, and assures access to state-of-the-art equipment and years of experience. Additionally the pharmaceutical product can be supported for multiple production sites or license partners without compromising or binding internal analytical resources. Focus on your internal resources, and let us partner you for the details – based on a individual, well-tailored program from development to release testing.

We will be happy to assist you with your project.

Don’t hesitate to contact us:

Thomas Flad

Dr. Thomas Flad

Director Business Development
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com

PPS Info Letter Nº 1/2018

Powered by Protagen Protein Services: Mass Spectrometry for Early and Enclosing Host Cell Protein Identification

Mass spectrometry (MS) becomes an essential tool for the conclusive identification of host cell proteins (HCP) and for a clear understanding of the purification process at an early stage. Based on two decades of experience in that field, Protagen Protein Services improves your production and purification processes by applying MS to the detection and identification of HCPs.

Enhancing Specificity and Efficiency

HCPs are process-related impurities clearly being considered as critically relevant and undesirable in the final drug substance. By their very nature, HCPs have the potential to provoke destructive reactions within the Drug Substance and/or to elicit an immune response in humans. However, current bioprocess technologies cannot produce absolutely HCP-free material from a living organism like commonly used Chinese Hamster Ovarian cell cultures (CHOs). Determining not only the quantity but also the identity of HCPs during any biopharmaceutical’s production is of utmost importance for patient safety and massively influences the product’s approval timelines. The application of MS to the detection and identification of HCPs significantly enhances the specificity and efficiency of your testing methods and minimalizes the risk of critical HCPs in the final product to an acceptable level.

Guidelines Mirror Growing Sensitivity

Undetected HCPs can have serious effects on a product’s character ranging from lipase and endoprotease activities or protein denaturation to unwanted immune responses and other direct impacts on the patient. Health authorities, knowing about the importance of evaluating HCPs, have been developing a growing sensitivity for HCP monitoring within the last few years, not least because of recent incidents having led to the complete withdrawal of clinical studies. The fundamental issue thus lies in establishing the best possible risk management based on an adequate 1. measurement, 2. monitoring, and 3. control of HCPs. Relevant guidelines, like USP, EP, and ICH, demand the highest possible degree of control for best detection and purification results.

Detection and Understanding: Increase Your Product’s Safety by Means of an Encompassing MS-based Risk Management

Most protagonists within the biotechnology industry currently use a combination of ready-made and customized ELISA immunoassays in order to reveal unwanted critical HCPs. Although these black box assays, based on the detection of antibodies, can come very close to it, they will provide neither a guarantee for an all-embracing disclosure nor for a complete understanding of process-related impurities. In order to fill the gaps to a complete detection and understanding of HCPs, an unbiased approach is necessary. PPS thus encourages you to apply MS technology in addition to the established immunoassay approaches to judge the safety of existing HCP control strategies. “Mass spectrometry can be widely applied and straightforwardly adjusted to different HCP related issues during product development”, says Thomas Flad, Director Business Development. “As HCPs do not have to be known prior to analysis, MS is the most reliable technology to meet up with the regulatory request for the application of orthogonal methods in the process of purifying the biological product from any cell-based impurities to a tolerable level before approval. Most importantly, PPS has recently successfully identified and quantified HCP within several late stage development candidates and thereby substantially supported approval processes”.

Protagen Protein Services partners you in establishing a comprehensive understanding of your product’s nature from harvest to approval. Applying mass spectrometry at an early stage as an additional tool to ELISA testing methods will significantly accelerate your product’s release process and enhance its chance of success.

We will be happy to assist you with your project.

Don’t hesitate to contact us:

Thomas Flad

Dr. Thomas Flad

Director Business Development
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com