Drug Product Development
Our product development services harness our 36+ years of experience in parenteral formulation and manufacturing to help clients overcome even the most challenging hurdles. From pre-clinical development through clinical supply and on to commercial manufacturing, we focus on optimizing your product’s stability and performance.
OUR CAPABILITIES
Liquid and Lyophilized Formulation & Process Development
Whether your product is a small molecule or a biotech pharmaceutical—protein, peptide or oligonucleotide—we can assist you in the design and execution of pre-formulation and formulation development studies to define your final formulation. The results of formulation development work will be integrated with primary packaging selection and process design phases, to meet or exceed your performance expectations for a clinically sound, marketable parenteral drug product.
If you choose to lyophilize your drug product, we have the experience and tools to design a stable dosage form, along with an effective and efficient lyophilization cycle. Our scientists apply extensive knowledge of successful formulation strategies for stabilizing sensitive protein and peptide pharmaceuticals. With a differential scanning calorimeter and lab-scale lyophilizers, we can expertly establish optimum lyophilization cycle parameters for your drug product.
- Liquid formulations
- Lyophilized formulations
- Suspension and dispersed-system dosage forms
- Manufacturing process design and optimization of existing processes
- Manufacturing scale-up and technology transfer
OUR PROCESS
Rapid Development of Elegant Drug Product Solutions
Our technical and analytical teams collaborate closely with clients, creating robust formulation processes for long-term clinical and commercial success.
01
Formulation Development
We develop stable drug product formulations for liquid and lyophilized drug products, including large molecules (proteins, oligonucleotides and peptides) and small molecules.
02
Manufacturing Process Development
We pioneer robust, compliant drug product manufacturing processes to fill parenteral drug products into vials and prefilled syringes.
03
Lyophilization Cycle Development
Our efficient lyophilization cycles can solve many challenges around drug product stability, storage and distribution—maximizing the shelf life of your drug product.
How Can We Help?
Let us apply our 36+ years of experience to help you solve your drug development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Labs.