Formulation development is essential for the therapeutic and commercial success of a promising therapeutic molecule.
Our Formulation development studies aim to render a biopharmaceutical drug product robust for manufacturing, storage, handling and administration to patients. We offer this service for many (bio)pharmaceutical drug substances, including proteins (such as monoclonal antibodies or hormones), peptides, vaccines, AAVs, virus-like particles, nucleic acid-based products, ATMPs or GMOs and more. A robust formulation is crucial already in early stages of research, because biopharmaceutical drug substances are often inherently unstable and require stabilization for handling. A variety of different product types are possible to stabilize a biopharmaceutical drug substance. Most common are liquid and lyophilized formulations. However, also frozen liquids or high-concentration liquid formulation (HCLF) can be required.
We are formulating innovation
By following our mission of “Formulating innovation”, we combine technologies, knowledge and experience to add substantial financial value to our client's projects by: generating IP for your pharmaceutical compound to support formulation patent application, supporting patent life cycle management in later phases, reducing time-to-market with tailor-made development strategies, increasing value of your drug development project for out-licensing and M&A activities. Coriolis will seek no financial participation in generated IP – no royalties, no milestone payments.
A good formulation development needs good analytical methods
A good formulation development can only be conducted when its foundation is a broad analytical portfolio, because if the employed analytics cannot detect critical degradation pathways, all formulations will appear stable. Thus, Coriolis Pharma will recommend a tailored analytical package to gain the maximum information on the stability of the molecule of interest from the generated sample.
With many years of experience in the field of formulation development, we can offer:
- pre-formulation screening: including identifying suitable formulation 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
- pre-clinical formulation development: liquid, frozen or dried formulations (e.g., for tox-studies) are developed and can be produced under sterile conditions
- transfer of formulations to the external CMO of our customers choice (thereby being much more price competitive and flexible) including process transfer on site if desired
- formulation development for clinical phase I and II
- formulations for late clinical development (phase III) and commercial application
Drug substances we work with
We have 13+ years of experience in handling a large variety of different products, including the following:
Antibodies, hormones and other therapeutic proteins
DNA, RNA and oligonucleotides
Gene- and cell therapy products and other GMOs
Oligopeptides, peptide hormones, and small proteins
Viral vectors, mRNA vaccines, virus-like particles and more.
Synthetic or biological small molecules