We are a contract laboratory that provides custom lyophilization services to our clients. HTD has successfully lyophilized many drug products and transferred the process into large-scale manufacturing. We develop lyophilized formulations for biologics (e.g. protein, antibodies, antibody-drug conjugates, enzymes), vaccines, liposomes, diagnostic kits, small molecules, implants and combination products to enhance product stability.
Lyophilization Process Development
We help our clients with complete process development of a scaleable lyophilization process that can be easily transferred to a cGMP manufacturing suite. Our scientists have extensive expertise with development of lyophilized products including:
At HTD we ensure that the lyo product has the required moisture content, cake appearance and stability. We test the lyo product using different assays such as:
We offer fill-finish and GLP manufacturing capabilities of up to 1000 vials using our pilot scale lyophilizers. We support our client with custom lyo cycle development, lyo-process development, batch product record and tech transfer.
We have developed lyophilized formulations for biologics, diagnostic kits and vaccines to enhance product stability. These include:
Proteins, antibodies, enzymes, peptides
Nucleic acids, DNA, siRNA, mRNA, oligonucleotides
Antibody-drug conjugates
Vaccines
Liposomes and lipid nanoparticles
Small molecules
Diagnostic Kits
Combination products
Excipients for lyo formulation development
Excipients are inactive ingredients that are used in lyophilized protein formulations to improve the stability, performance, and convenience of the product. Excipients can be classified into several categories, including bulking agents, stabilizers, and process aids. Stabilizers are excipients that are used to protect the protein from degradation and to improve its stability during storage. Examples of stabilizers include sugars (e.g., sucrose, trehalose), amino acids (e.g., arginine, histidine), and surfactants (e.g., polysorbates, lecithin). Overall, excipients play an important role in the development of lyophilized protein formulations, and our team of protein scientists has extensive experience in the selection and optimization of excipients for specific applications. Please click here to learn more.
Contract Research and Development
Services for bilogics drug development
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HTD has worked and collaborated with many companies, governments, and academia.
About us HTD is a private company located in Livermore, California. HTD has worked and collaborated with other companies, governments, and academia. Our researchers have helped other companies develop their products.
