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Contract Development and Manufacturing
of Liposomal Formulations

Liposomes protect, transport and release your drug at the right place and time. By this, a reduced dose achieves better efficacy and avoids side effects with a non-invasive application. A liposomal formulation can clearly improve the therapeutic index of your drug.

License agreements are offered for the respective substance on an exclusive basis. Contracts can be arranged step by step - proof of concept, in-depth analysis, GMP production, product license - or all in one.

Formulation Development

Polymun offers the development of liposomal formulations for all kinds of pharmaceutically active ingredients such as oligonucleotides, small molecules and proteins as well as vaccine antigens. Different encapsulation techniques are employed, depending on the nature of the drug. Hydrophilic substances are passively entrapped. Amphiphilic substances are actively loaded, hydrophobic drugs and membrane proteins are incorporated into the membrane of the liposomes.

Analytical Method Development

A broad spectrum of analytical methods has been established with various liposomal formulations for testing of intermediates, APIs and finished drug products. They can be readily adapted for new products. Qualification and validation of analytical methods for each project are performed according ICH guidelines.

Process Development

Our patented liposome production technology is the key to a high quality solution for a broad range of active ingredients and vaccine antigens. Alternative to Polymun's own technologies, non-proprietary technologies and existing customer processes can be implemented. Based on our long-term experience, we will develop the optimal process for your liposomal formulation.

GMP Production

Polymun produces GMP material including all necessary documentation for IMPD/IND.

Filling

- Manual filling of glass vials (2 mL to 20 mL) with up to 1800 vials per fill
- Manual filling of plastic containers (various sizes and formats)
- Available soon: Automated filling line for glass vials (2 mL to 20 mL) with up to 10,000 vials per fill
- Available soon: Freeze-drying

- Validation of filling process by media fills

Release and Stability Testing

- Release testing of drug substance and final drug products including release for human use by a Qualified Person according to EMA requirements
- Stability studies at various temperatures: -70 °C, -40 °C, -20 °C, 2-8°C, 23-27 °C, 35-39 °C, 38-42 °C, photostability

Clinical & Regulatory Support

Polymun has organised many clinical studies in various indications over a period of more than 20 years. This expertise is now available as service for our customers for clinical and regulatory support.

 


Advantages of Liposomal Formulations

PROTECTION

Liposomes shield the drug from degradation. In the body, liposomes prolong the biological half-life.

SOLUBILIZATION

Liposomes can enhance solubility within the aqueous core and the lipid membrane.

TARGETED DRUG DELIVERY

Depending on their lipid composition, liposomes are able to localize, to target and to interact specifically with the affected tissue.

NON-INVASIVE APPLICATION

Liposomes can target the skin and the tissue below. The mucosa is an excellent target for quick uptake of liposomal drug formulations. Alternatively, liposomes can be inhaled in order to target the lung.

SUSTAINED RELEASE / LOW APPLICATION DOSE

Liposomes constitute a depot of the drug resulting in sustained release. Thereby, undesired peak concentrations are avoided and availability is prolonged. This results in a lower frequency of application and the reduction of side effects.

TOXICITY MINIMIZATION

Liposomal formulations are used in cancer treatment for reducing the toxic side effects of the drug.

OVERVIEW

  • Formulation Development
  • Analytical Method Development
  • Process Development
  • GMP Production
  • Filling
  • Release and Stability Testing
  • Clinical & Regulatory Support

GMP Production

Process Development

DOWNLOAD LIPOSOMAL BROCHURE

Polymun Liposome Technology 
Broschure (pdf, 1MB)