Biopharmaceuticals, also called biotherapeutics or biologics, have revolutionized therapies of various deseases such as diabetes, certain types of cancers and immunologic conditions. In particular with regard to chronical and severe clinical conditions like multiple sclerosis, rheumatoid arthritis or cancer they are considered to be the future of treatment. Especially in nascent personalized medicine patients with serious rare deseases can benefit massively from tailored biologics in the future.
Biologics are large protein drug molecules with complex structures produced from a biological source within a biotechnology process. The first such product approved for therapeutic use was human insulin as a recombinant protein. Insulin is the most commonly used biopharmaceutical agent worldwide. biotherapeutics as a product group include hormones, monoclonal antibodies (mAbs), cytokines, growth factors, gene therapy products, vaccines, cell-based products, gene-silencing/editing therapies, tissue-engineered and stem cell therapy products. Many of the biotherapeutic molecules being in development or recently having been approved are mAbs and these are considered the most rapidly growing drug class in oncology, anti-immunity, and chronic inflammatory diseases.
The development and manufactoring of biologics is a complex process, which starts by identifying potential drug targets, and by finding a suitable drug lead. The candidate then, is tested through toxicology studies, until finally its safety and efficacy has to be assessed in clinical studies before the drug is ready for approval and commercialization.
Throughout the drug development, an increasingly deep understanding of the molecular features and their relevance for the potency of the candidate is of utmost importance.
We offer in-depth experience in analytical service in protein science for:
- Antibody Drug Conjugates (ADC)
- Bispecific Antibodies
- Fab Fragment
- Fusion Proteins
- Other Formats
PPS provides analytical support across a broad range of specific analytics, including characterization, stability and comparability testing, bioanalytical and release testing. Our experts bring in 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.
Developability is an assessment of the suitability of a biological candidate to be successfully developed into an effective therapy. Can the candidate be manufactured, formulated for the appropriate route of administration and provide the desired pharmacology and pharmacodynamic characteristics? Protagen Protein Services (PPS) provides comprehensive and state-of-the-art developability assessment service for your biopharmaceutical candidates, in order to address potential manufacturing and safety risks at the early stages of the discovery and development processes can build quality into your product, by design
The development of a manufacturing process for the production of a biological is very complex and is typically comprised of four parts: Upstream Processing, Downstream Processing, Formulation and Delivery
Proteins are complex molecular entities derived from biological processes. They differ from each other in their size, molecular structure and physiochemical properties. These differences allow for protein analysis and characterization by separation and identification. Protagen Protein Services (PPS) offers protein analytics as part of an integrated package of expert analytical services
The assesment of the appropriate and functional components in formulation development for biopharmaceuticals is a prerequisite for a market success of a new drug product. Formulation development support can start from the beginning accompanying the molecule development cyclewhen information on stability is not yet available
Comparability studies play a vital role in biopharmaceutical developments. With regard to changes within production processes, the purpose of assessing comparability is to show that the pre- and post-change drug products are comparable in terms of quality, safety, and efficacy. Regarding the development of biosimilars, comparability studies are required to generate evidence that demonstrates similarity of the biosimilar and the innovator product with regard to the quality, safety and efficacy. Comparability studies are supposed to include characterization studies and the eyaluation of physicochemical properties, biological activity, product- and process-related impurities, and stability.
Host cell proteins (HCPs) are low-level, process-related protein impurities in drug products derived from the host organism during biotherapeutic manufacturing. Protein impurities may generate undesired side effects. So characterizing protein impurities is a key requirement of ICH Q6B. We identify and quantify all the proteins in your mixture using mass spectrometry.
Method Validation and Verification
Method validation and verification provides objective evidence that a analytical method is fit for purpose, meaning that the particular requirements for a specific intended use are fulfilled. This includes full method validation according to ICH guidelines or verification based on PharmEu or USP documents and can be followed by release testing.
Forced Degradation Studies
Forced degradation is the process of subjecting drug compounds to extreme chemical and environmental conditions to determine product breakdown levels and preliminary degradation kinetics, and to identify potential degradation products. Forced Degradation Studies or also called Stress studies will be performed according to ICH Q1A. Stress studies are required throughout the entire development of biopharmaceuticals. We perform stress studies ideally prior to method validation to also be able to use the generated stress samples for method validation.
Stability studies are a critical step in the drug development process. These studies allow assessing the shelf life of a new drug and also allow studying possible degradation pathways in more detail. In the field of biosimilar development, stability studies are mandatory to show the comparability of biosimilar and innovator also under stress conditions.
Drug products entering the pharmaceutical market require release testing in accordance with regulatory standards. Good Manufacturing Practice (GMP) is a set of guidelines for the production and testing of drugs such as biopharmaceuticals. The main focus of GMP is to ensure the safety of drugs GMP standards for protein drugs include the manufacturing of both new molecular entities and biosimilars. Sophisticated technologies in protein characterization and analysis are required to guarantee the efficacy, identity, purity and safety of biotherapeutics.
Good Manufacturing Practice (GMP) is a set of guidelines that outline rules that apply to the production and testing of drugs such as biopharmaceuticals. The main focus of GMP is to ensure the safety of drugs and to set up a rational for the safe release of drugs into the market. As a consequence of the complexities of protein drug manufacture, the GMP standards were amended for biotherapeutics in order to cope with the manufacture of both new molecular entities and biosimilars. As a result, sophisticated technologies in protein characterization and analysis are required to guarantee the efficacy, identity, purity and safety of bio-therapeutics.
This guidance document ICH Q6B provides a uniform set of internationally accepted specifications for the characterization of biotechnological and biological products to support new marketing applications. These specifications establish the set of criteria to which a drug substance, drug product or materials at other stages of the manufacturing process should conform in order to be considered acceptable for its intended use. They are one part of the total strategy designed to ensure both product quality and consistency.
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:
- Clone Selection & Process Development
- Extendend Characterization & Comparability
- Stability & Release
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science. More than 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry.
PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity