HTD Biosystems is your expert in drug development, with a strong track record of success in bringing innovative therapies from discovery to the clinic. Our team includes seasoned professionals with a wealth of experience in drug discovery, preclinical development, clinical development, and manufacturing.
HTD Biosystems specializes in customized lyophilization and biotech drug development services, utilizing advanced techniques and extensive experience to deliver high-quality pharmaceutical products.
The benefits of working with HTD include flexibility, innovation, speed, and customer focus. We are able to respond quickly to changing project conditions and customer needs. We are open to taking calculated risks and trying new approaches to ensure that we are at the forefront of drug formulaton/delivery research and development.
Protein Characterization & Formulation Development
Our protein characterization includes tertiary conformational, thermal stability, and colloidal stability (by DLS and FlowCam subvisible particle) analysis and biochemical protein analysis. We leverage our unique iFormulate™ platform. This platform utilizes an advanced algorithm for high-throughput analysis, integrating rational multivariate experiment design using DOE with four critical formulation parameters. Its focus is on developing stable drug products, including high-dose protein formulations. It effectively tackles challenges such as protein conformational and thermal stability, protein aggregation and solubility, The deliverables are developing both stable liquid and lyophilized products.
Lyophilization Process Development
Our lyophilization development focuses on freeze-drying proteins, liposomes, diagnostic kits, and small molecules. We emphasize the importance of successful scale-up to large production size dryers. The deliverable is a robust cost-effective cycle with detailed characterization data to rationalize lyophilization cycle and the drug product.
Manufacture of GLP Tox Lots Under Aseptic Fill/Finish Operations
We can aseptically manufacture and Fill/Finish Tox lots under GLP using BPRs that can be transferred to a cGMP facility for liquid and lyophilized products.
Liposomal & Lipid Nanoparticle Development
HTD has expertise in the development of liposomes and lipid nano particles for drug delivery applications of small molecules, proteins, and nucleic acids. We have developed a number of Drug Products such as vaccines, delivery systems of entrapped small molecules, and lipophilic drugs.
Consulting Services in Drug Development & Process Development
Our consulting services in biopharmaceutical drug and process development provide expertise in developing biological drugs, addressing challenges like product stability and manufacturing optimization. We collaborate with pharmaceutical companies to expedite product development, ensuring compliance and efficiency in bringing safe, effective biopharmaceuticals to market by bringing clarity to your Target Product Profile.
Posted Date: 11/27/2023
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