Drug development is a challenging process and needs an effective project management. Increasing complexities of markets, long-term business strategies, and release requirements are giving point to relying on the expertise and experience of an extern partner such as PPS. We offer you a strong, supportive partnership, allowing you to focus on your core competencies while relying on our deep know-how, long-term experience, and detailed expertise concerning development processes, testing methods, and release requirements. The PPS project management provides guidance and advice for your project’s challenges in order to ensure its successful completion.
Our project managers have a broad scientifical and technical background. Within our PPS project management program every project is accredited with a project team dedicated to being a valuable partner in your research and to supporting you at gaining a deeper understanding of your molecule. Charged with the responsibility of keeping a project on schedule and within budget your PPS project management team proactively identifies any potential issues before problems arise. Our logistical and scientifical partnership program mainly focuses on
- logistical support such as
- logistics and sample coordination
- elaboration of a comprehensive reference product data sheet and a method control chart
- scientific support with
- originator screening
- stability studies
- impurity characterization
- clone selection
- process development and optimization
Professional und individual supervision
Each project is being overseen by a project manager who is experienced in GMP operations and committed to ensuring feasibility and alignment of your expectations with our technical capabilities. The PPS project manager is your responsible contact person throughout the whole cooperation process, fit to answer almost all upcoming questions directly without additional internal inquiry loops. Your project manager
- supports you at developing a detailed project plan,
- identifies necessary adjustments to mitigate risks,
- actively monitors the project and keeps you informed through regular reports and meetings,
- ensures your project stays within timeline and budget.
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