Radiopharmaceuticals that combine smart peptide technologies with flexible GMP conform manufacturing capabilities
Peptides play an important role in the rapidly-growing field of theranostics. This is because the properties of peptides are ideal for delivering both radioactive markers and therapies to a tumor. Pepscan employs some of the industry’s finest chemists to design the radiolabeled peptides fit for your purpose.
Pepscan has a proven track record in the field of radiopharmaceuticals and synthesized precursors for radiolabeled peptides suitable for a wide range of applications. Next to existing peptides for customers, Pepscan also produces peptides emerging from our Peptide Discovery services. These services utilize our unique CLIPS™ phage display platform to discover highly constrained de novo peptides with enhanced affinities, selectivities and proteolytic stabilities.
Turning your project into a success story
We assist you in progressing your peptide project through the various stages of clinical development, application and commercialization. Our lean processes and organization meet the pharmaceutical industry’s standards and support us in making your project a success story.
At the start, every project undergoes a feasibility and optimization process. Once we identify the optimal process, we create and review a detailed plan in consultation with you and your team. As an additional service, we deliver a CMC report that can be used for regulatory filing (IMPD /IND/HREC). Our facility, including aGrade D cleanrooms, can manufacture APIs in volumes from milligram to gram, conforming to GMP for clinical phases 1 and 2 (according to EudraLex, volume 4, part II). For Phase 3 and commercial supply, we produce in an FDA/Swissmedic-inspected plant in Switzerland.
Metal chelators for one-step labeling of peptides
Pepscan’s chemists introduce metal chelators either at the N-terminus or at the side chain of a lysine residue in the sequence. The chelators we offer are:
- DTPA, DOTA, NOTA, DOTA-GA and others. These chelators display a high affinity to commonly used multivalent radioactive metals, like Lu-177 (177Lu), Ga-67 (67Ga), In-111 (111In) or Y-90 (90Y), or the cold metals Gd(III), or Y(III) used as MRI contrast agents or in PET or CT imaging.
- DFO (for Zr4+ or Fe3+ complexation), can also be introduced in peptides with only a few restrictions.
- Technetium (Tc) chelators, e.g. mercaptoacetyltriglycine (MAG3) or water-soluble derivatives thereof, are readily incorporated into site-specific labeled peptides with Tc-99m (of 99mTc).
- Radioactive iodine labels (125I) are readily introduced via iodination at any tyrosine residue (or derivative thereof) in the sequence.
- Pepscan provides disulfide-rich (DSR) peptides for tumor-targeting applications, in combination with almost every commercially available fluorescent dye (e.g. AlexaFluor 488, 594, 647 and Rhodamine/TAMRA).
- Pepscan produces your desired complex peptides, incorporating non-natural amino acid building blocks, like naphthylalanine, citrulline, etc.).
Key benefits of working with Pepscan
- We are a full-service peptide service, from peptide discovery and lead optimization to R&D production.
- Our strong track record and flexible GMP manufacturing capabilities mean that you can start your project with confidence.
- Our in-house peptide expertise at our facility in Lelystad, the Netherlands enables short timelines for the several phases of GMP-compliant production.
- Our best-practice template for processes, analytical methods and documentation greatly reduces development effort and time.
- Our experts will optimize synthesis protocols in peptide chemistry during a feasibility project.
- We offer a range of GMP-compliant analyses, including amino acid analysis, peptide content, water content, and residual solvents (ACN/TFA/DMF, etc.).
“Since we only need small doses of this complex GMP-grade product, we were looking for a company that has both the facilities and expertise to make this work for us. The scale of Pepscan’s organization not only provided us with a level of flexibility that probably cannot be found in large scale CDMOs but also allowed us to work closely with all people involved in the development and manufacturing process.” Read furtherHerman Steen, CEO of BiOrion