Lyophilization Services 

Lyophilization Development

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: 

Analytical Testing & Stability Studies

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:

Pilot Scale GLP Manufacturing

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.

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Protein FormulationProtein Formulation
Lyophilization Services
Lyophilization Process Development
Lyophilized FormulationLyophilized Formulation
Manufacturing of Pilot Lots
Lyophilization Optimization & Scale Up

Formulation Development

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.

Lyophilized FormulationLyophilized Formulation
Contract Research and Development
Services for bilogics drug development