Drug Development

HTD Biosystems helps with development of  biotherapeutics  

Stability Studies

Accelerated stability studies are a type of stability testing that is used to evaluate the stability of proteins in liquid and solid dosage forms under conditions that are more severe than those that the product will typically experience during storage and use. The goal of accelerated stability testing is to determine the shelf life of the product and to identify any potential degradation mechanisms that would occur under normal storage conditions.

There are several factors that can affect the stability of proteins in liquid and solid dosage forms, including temperature, humidity, light exposure, pH, and the presence of other chemicals or contaminants. During accelerated stability studies, the protein is exposed to conditions where the instability mechanisms happen more rapidly without exposure to extreme conditions that would cause protein degradation.  These studies are typically done below the onset of protein denaturation or other stress conditions that can affect protein stability.

To conduct accelerated stability studies of proteins in liquid and solid dosage forms, a sample of the product is prepared and stored under accelerated conditions for a specified period of time. The protein is then analyzed at regular intervals to determine its stability, including its concentration, purity, and functional activity. Any changes in the protein's properties are monitored and used to determine the shelf life of the product based on the primary instability mechanisms.

Accelerated stability studies are an important part of the development and quality control of proteins in liquid and solid dosage forms, as they can offer a preview of real time stability if performed correctly.  HTD has expertise in accelerated stability studies and can provide high-quality services to our clients to support the development of safe and effective products.


Peptide Development and Characterization

HTD offers a range of services for the development and formulation of peptide drugs. Our expertise in peptide drug development includes:
  • Peptide characterization: We use a range of techniques to analyze the purity, identity, and activity of peptides, including UV Spectroscopy.  Additional analysis such as mass spectroscopy and HPLC can be sourced out to our expert network.
  • Peptide formulation: We have extensive experience in developing stable, bioavailable formulations of peptides, including injectable solutions, suspensions, and lyophilized cakes.  We also employ a number of solubilization strategies for increasing peptide solubility through formulation.
  • Peptide stability studies: We conduct accelerated and real-time stability studies to evaluate the stability of peptides under different storage conditions and over time.
  • Peptide drug delivery: We have experience in developing targeted and controlled release formulations of peptides, including polymeric gels, nanocarriers and liposomes.
Our team of experts is dedicated to helping clients bring peptide drugs to market through innovative formulation development and quality-by-design approaches. We have a proven track record of successfully developing and manufacturing peptide drugs for preclinical and clinical studies.

Safety testing:
We conduct comprehensive safety evaluations of vaccine candidates using a range of in vitro assays, including sub-visible particle analysis, vaccine integrity, and antigen-adjuvant interactions.

If you are looking to develop a new vaccine or need support with an existing vaccine project, we can provide the expertise and resources you need to succeed.

Parenteral Drug Delivery Systems

In addition to our expertise in targeted drug delivery systems, HTD Biosystems also has a strong track record in the development of parenteral drug delivery systems.

Parenteral drug delivery refers to the administration of drugs through routes other than the oral route, such as injectable formulations administered intravenously (iv), sub-cutaneously (sc), intra-muscular (im), and intra-dermally (id).

Our team of scientists and engineers has a deep understanding of the challenges and opportunities of parenteral drug delivery, and we have developed a wide range of injectable formulations, including solutions, suspensions, emulsions, and lyophilized products.

We have a proven track record of success in the development of parenteral drug delivery systems for a wide range of indications, including cancer, inflammation, infectious diseases, and immunology (vaccines). We are committed to advancing the field of parenteral drug delivery and to developing innovative solutions that improve the effectiveness and safety of treatments for patients.