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We are a highly specialized contract research and development organization in the field of injectable
peptides and proteins for human use.
About us
Formula Lab is dedicated to designing laboratory scale development programs for the next generation therapeutic peptides and proteins.
What we do
Services
Drug Product Development
We specialize in providing comprehensive support for the formulation development of injectable peptides and proteins across all core disciplines. Our expertise spans from the initial stages of development, where we can create formulations for toxicity studies and non-clinical pharmacology, to the finalization of the drug product for human use. All of our development work is conducted in our laboratory located in Copenhagen, Denmark.
Technology Transfer
We go above and beyond by ensuring a seamless transition of the drug product to GMP manufacturing. We take on the responsibility of either transferring the drug product to the first GMP manufacturer or assisting in the screening and selection of a suitable Contract Manufacturing Organization (CMO) for clinical manufacturing. Our commitment to your project extends beyond formulation development, ensuring a holistic approach to your pharmaceutical needs.
Data Analysis
We deeply value the power of advanced data analysis. When you entrust us with your data, we guarantee to maximize its value through meticulous data visualization and sophisticated statistical modeling. Moreover, we offer in-silico modeling of your molecule, extracting invaluable insights without the need to sacrifice even a single milligram of API.
Regulatory Documentation
And to add the final touch, our team of CMC experts is delighted to assist in the technical writing of the Module 3 sections in your clinical trial dossier. We bring with us substantial expertise in navigating the intricacies of US and EU regulations, particularly for aseptically manufactured injectable drug products. Your comprehensive pharmaceutical journey is our commitment.
Analytical Development
We provide analytical services in our own laboratory. In lead selections studies we employ standardized methods, and in subsequent clinical development stages, we apply quality-by-design principles to develop customized UHPLC-methods for your drug candidate enabling evaluation of purity, impurities, aggregation and other key quality attributes.
In Silico Modelling
We provide comprehensive computational analyses to support the early development of peptides, proteins, and antibodies. Our workflows identify labile amino acids, predict degradation pathways, performs electrostatic mapping and calculate key physicochemical parameters, offering valuable insights without consuming API. From primary sequence analysis to structural modeling of your drug, we deliver clear risk assessments that guide formulation, analytical strategies, and regulatory documentation.
Why Choose Us?
Science
We possess a deep understanding of the applied scientific domain related to peptide and protein therapeutics
Experience
Our Management has more than 50 years of industry experience and have worked on several molecules which are popular commercial products today
Timelines
Reaching your clinical milestones is our mission. We always craft project plans that guarantee you hit those timelines