Robust Formulations for Therapeutic and Commercial Success

From the early stages of research and development, a robust formulation is crucial for paving the road to a successful commercialization because biopharmaceutical molecules are often inherently unstable and require stabilization. Our formulation development services deliver biopharmaceutical drug products that are robust for manufacturing, storage, handling, and administration to patients. We offer formulation development for wide range of structurally diverse (bio)pharmaceuticals, including proteins, vaccines, gene therapy products, viral vectors, nucleic acids, antibodies or related products, peptide, cell therapy products, drug delivery system and small molecules. 

Liquid, frozen and lyophilized formulations tailored to your needs

We develop formulations for liquid, frozen and lyophilized drug products that fit the needs of your molecule and development phase. In a unique collaborative approach, our experts concentrate on your target product profile (TPP) and tailor the study design to your requirements. We consider drug substance availability, relevant deadlines and your overall development strategy when conducting a project. Already during initial project discussions with us, you will benefit from the advice of our distinguished scientific advisory board. Also, our large service portfolio gives you the flexibility to readily switch from a liquid to a lyophilized formulation or explore different formulation types in parallel.

With many years of experience in the field of formulation development, we offer:

● preformulation screening: including identifying suitable formulation corridor and composition (pH, ionic strength, protein concentration, excipients, etc.); identifying degradation products; selecting stability-indicating methods; high throughput formulation approaches based on design of experiment are possible to reduce the required material and time
● preclinical formulation development: liquid, frozen or freeze-dried formulations (e.g., for toxicological studies) are developed and can be produced under aseptic conditions
● transfer of formulations to the external CMO of your choice including process transfer on site if desired. This reduces your costs and maintains your flexibility
● formulation development for clinical phase I and II
● formulations for late clinical development (phase III) and commercial application

Get a tailored formulation development for your product

Our formulation development will be tailored to your specific drug substance, development phase and target product profile (TPP), and is backed by many years of experience with similar drug substances. Click on a product type to explore our entire portfolio of specialized development and analytical services.

Quality & biosafety level of this service

We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:

Our know-how related to formulation development

Pekin Pharma is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars.

Our other services

Pekin Pharma provides a wide range of science-driven and tailor-made solutions for many research, development, and analytical challenges. Explore all our services and learn  how Coriolis can support your drug development program. Together, we can make future therapies available to patients and improve the quality of life for humankind.

Turnkey Project for Biosimilar manufacturing

Pekin Pharma provides complete design, engineering, construction, start-up of new pharmaceutical facilities, even assisting the Clients through scouting activities of potential Know How Licensor, transferring the Know How, providing Validation Master Plans and Standard Operating Procedures, validating, aligning industrial processes to URS and regulatory requirements.

The necessary training for operation and maintenance of the lines is provided by our expert technicians at the system start-up, ensuring a full understanding of how the equipment works and how to operate for effective sanitization/sterilization and troubleshooting. Different training for different access levels to the system is taken into account and recorded on the group certificate of attendance. Action options and limitations for the End-User, which are diversified according to the access level, are clearly highlighted during training.

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