DRUG DEVELOPMENT SERVICES
HTD provides services for accelerating development of parenteral drugs, using novel high throughput technologies. HTD's unique expertise in design of experiments (DOE), formulation of nano-lipid particles, protein formulation, vaccine development and lyophilization, makes it the right partner for any company that is seeking to outsource formulation development or is interested in targeted delivery of DNA, peptides and proteins.
Design and Development of Smart Delivery Systems
With a combined expertise in protein formulation development, lyophilization, solid-state structure and liposomal drug delivery systems, HTD is the right partner for development of your next smart delivery system for delivering antibodies, immunotherapy medicines, anti-cancer drugs, antigens, vaccines, DNA and Proteins. We have extensive experience from pH sensitive liposomes, PEGylated liposomes, remote loaded liposomes and other forms of nano-particulate systems both as liquid and as freeze-dried products. Concepts developed at our company have been licensed to companies such as Pfizer by our clients.
We provide customized lyophilization services and develop efficient freeze-drying cycles for various biotech drugs ranging from small molecules, peptides, proteins, and drug delivery systems (e.g liposomes). Our expertise and experience in thermal analysis and solid state characterization helps us in developing robust lyophilized formulations and freeze-drying cycles that can be efficiently tech-transferred to cGMP manufacturing facilities. Similar approaches are also applied to spray drying of drug products.
HTD lyophilization flyer
HTD has a vast experience with vaccines and over the years has developed several vaccines for its clients. The vaccines developed by HTD Biosystems are currently at different stages of clinical trials. HTD has been involved in development of traditional aluminum salt based vaccines (such as a pentavalent vaccine against Botulism) both as a liquid and as a freeze-dried product, cancer vaccines and other therapeutic vaccines for human and veterinary medicine. In these projects, HTD has collaborated with different stakeholders and partners, such as universities, small and large Pharma and International companies.
"Great Results, Expert, On Time" .
HTD Biosystems accelerates development of biotech drugs, using a unique formulation development platform iFormulate. This concept is based on an efficient high throughput algorithm that utilizes rational design of experiments and formulation parameters, to develop pharmaceutically acceptable drug product. Protein formulation development by iFormulate
Over the years we have helped our clients with development of their protein drug candidate into a stable drug product. We have developed high dose protein formulations and helped our clients overcome challenging formulation problems such as protein aggregation, and solubility problems. Using iFormulate platform, HTD helps with rapid antibody screening and selection for the most stable formulation.
We provide biophysical analysis of your protein or antibody. These include:
Particle size analysis, conformational analysis, determination of denaturation temperature, solubility, concentration, solid-state characterization, moisture
We help our clients with GLP fill-finish for toxicological studies. Our fill-finish capacity is 1000 vials per lot in Class 100 under aseptic technique.