Starpharma is an innovative biotechnology company with over 20 years of dedicated experience advancing novel solutions through our cutting-edge dendrimer technology platform. Our commitment to innovation drives us to explore new possibilities via internal development, as well as strategic partnerships and collaborations, all with the aim of delivering meaningful patient outcomes using our advanced dendrimer technology.

Starpharma has extensive chemistry, analytical, manufacturing, and quality experience spanning drug discovery through to the development of clinical trial material and supply of commercial medical devices. We have modern facilities and equipment in our laboratories designed to support the development of our in-house projects and partnerships.

Starpharma has extensive research and development (R&D) capability for in-house and partnered programs. Our experienced chemistry team routinely perform the following activities:

• DEP® dendrimer synthesis – conjugation of small molecule active pharmaceutical ingredients (APIs) to dendrimers for improved solubility, pharmacokinetics (PK) and drug release.
• Targeted DEP® dendrimer synthesis – conjugation of targeting moieties such as antibodies, antibody fragments and peptides to dendrimers (with payloads) for improved targeting to diseased tissue.

Starpharma performs in-process reaction monitoring and quality control (QC) release. Our experienced analytical team regularly perform the following:

• High-Performance Liquid Chromatography (HPLC): method development, validation and testing:
  • Reverse Phase Chromatography (RP)
  • Size Exclusion Chromatography (SEC)
  • Ion Exchange Chromatography (IEX)
  • Hydrophilic Interaction Liquid chromatography (HILIC)
  • Hydrophobic Interaction Chromatography (HIC)
• Liquid Chromatography - Mass Spectrometry (LC-MS)
• Water content testing
• Enzyme-linked Immunosorbent Assay (ELISA)
• Endotoxin testing
• Fourier Transform Infrared Spectrometry (FTIR)
• Nuclear Magnetic Resonance Spectrometry (NMR)

Starpharma obtained a manufacturing licence from the Australian Therapeutic Goods Administration (TGA) in 2020 to produce non-sterile dendrimer drug conjugates for use in clinical trials. Starpharma was most recently audited by the TGA in April 2024. Our custom-made manufacturing facility contains reactors, filters and ultrafiltration equipment designed to safely handle cytotoxic materials on scale.

Our experienced Quality team is involved throughout the product development and manufacturing process and works collaboratively with internal and external stakeholders to foster a quality culture within the organisation.

Starpharma’s mature Quality Management System is certified to both ISO 13485 and Good Manufacturing Practice (GMP) and places great importance on product quality, ensuring our products are manufactured, tested, and released according to the highest quality standards, complying with the safety and efficacy standards set by the TGA and other regulatory agencies.