Formulation Development
HTD Biosystems offers formulation development services for biologics, including proteins, peptides, vaccines, and liposomes. We have extensive experience with various forms of modalities such as monoclonal antibodies, bispecific and multi-specific antibodies, fusion proteins, nanobodies, fab, enzymes, antibody-drug conjugates and pegylated proteins.
Protein & Peptide Formulation Using iFormulate Platform
HTD has also developed a platform for formulation development using design of experiments (DOE) called
iFormulate. Using this platform, we have helped hundreds of clients to rapidly formulate their drug substance into a stable formulation that has been approved by FDA as part of their IND or BLA applications. We provide a formulation development package that is based on a rational DOE design and backed by multi-variate data analytics and reporting.
Formulation Development of Liquid, Frozen or Lyophilized products
We have helped our customers with development of liquid formulations for parenteral delivery of proteins, antibodies, liposomes and vaccines.
Co-formulation Development of Biologics
Following an increased interest in coformulation development, we published a cover article on co-formulation development of biologics in combination products in the American Association of Pharmaceutical Scientists (AAPS) Magazine on Aug 2019. You can contact us to receive a reprint.
High Concentration Protein Formulations
We have worked with development of several high concentration protein formulations for our clients. We have used various methods to increase protein concentration from 1 mg/mL to 200 mg/mL. We also scale up the process, using Ultrafiltration and diafiltration (UFDF).
Vaccine Formulation Development
Alum-based vaccinesWe have extensive experience of formulation and lyophilization development of vaccines. You can learn more about our work with alum-based vaccines by reviewing one of the papers that we have published on Stability of a Trivalent Recombinant Protein Vaccine Formulation Against Botulinum Neurotoxin during Storage in Aqueous Solution
here.
Liposomal vaccines
We have also developed several liposomal vaccine candidates for our clients and collaborators and helped tech transfer these formulations to GMP manufacturing sites.
Learn more about our vaccine development capabilities
here.
Learn more about our formulation capabilities
here.
Protein Formulation Development for Pulmonary Delivery
HTD has collaborated with several universities on formulation development. For example we worked with Professor Kathleen Stringer on development of a pulmonary formulation of tissue plasminogen activator. The results were published in a series of papers including:
Accelerated dosing frequency of a pulmonary formulation of tissue plasminogen activator is well-tolerated in mice,
click here to read more.
Formulation Development of Liposomes, Lipid Nano Particles (LNP) & Gene Therapy Products
We offer services in liposome and LNP design, formulation and manufacturing process development. We have successfully developed several liposomal formulations for targeted delivery for cancer therapy. We can formulate and manufacture liposomes in several sizes and with different properties for interaction with specific immune cells and targets.
Find out more about our liposomal formulation and manufacturing capabilities
here.