Formulation development is an important aspect of product development.
We utilize our extensive experience, expertise, and novel technologies to address complex formulation and drug delivery problems
At HTD Biosystems Inc., we utilize Design-of-Experiments to identify the right formulation.
Using our pre-designed formulation plate iFormulate and high throughput technologies, we are reducing the time and cost that it takes for a biotech drug substance to transit from discovery to clinic.
We provide services for product and process development of biopharmaceuticals using a rational formulation design strategy and high throughput technologies, that help our clients transit into clinical trials more rapidly and at reduced cost. We offer complete preclinical package including pre-formulation, formulation, lyophilization cycle development, pilot plant freeze-drying and fill-finish.
Expertise in multivariate experimental design (DOE) and our pre-designed iFormulate™ plates in combination with high-throughput technologies such as label-free nano Differential Scanning Flourimetry (nano DSF) gives us a competitive advantage compared to traditional formulation development. We can thus determine and predict protein stability and provide the right formulation rapidly and at reduced cost.
By a rational formulation design and accelerated studies, we will identify 2-3 lead formulations, using minimum amount of active drug substance. We will work with our client to make sure the final drug product, lyophilized or liquid is stable and in accordance with the FDA requirements. We help our clients with writing documents required for IND filing. Client will own all the results, the product and the potential patent.
Our Approach to Protein Formulation Development