PDF《Polymun Scientific》

Liposome Technology Polymun Scientific Immunbiologische Forschung GmbH Services Formulation Development Analytical Method Development Process Development GMP Production Filling Clinical &

Regulatory Support clinical &

regulatory support IMPD?/?IND, IRB Submission Pre-/Clinical Development Concepts Organisation of Clinical Studies Legal Representative Requests for Scientific Advice Technology Full Scalability Single Step Process Aseptic Process Homogeneous, Uniform Vesicles Excellent Batch to Batch Consistency Mild Procedure C Stability Liposome Technology Polymun Scientific Immunbiologische Forschung GmbH 苏州微流纳米生物技术有限公司 进口均质机、脂质体挤出器、激光粒度仪 www.

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18550201458 Liposomal Formulation of Drugs excellent Batch to batch consistency Mild Procedure ensures Stability The crossflow injection technique is a very mild procedure that allows processing of sensitive drugs. High quality raw materials and precisely controllable process parameters guarantee high batch to batch consistency C essential for pharmaceutical products. Consequently, we achieve long term stability of liposomes even at room temperature. 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. Polymun liposomal products are stable over years Months ?g/ml mg/ml mg/ml PDI nm

0 3

6 9

12 18

24 36 0,0 37,5 75,0 112,5 150,0 SIZE 0,00 0,06 0,12 0,18 0,24 PDI 0,0 0,3 0,6 0,9 1,2 1,5 LIPID2

0 4

8 12

16 20 LIPID1

0 250

500 750

1000 API Airport VIE Size (nm)

10 0.1

100 1,000 Intensity (%)

20 15

10 5

0 batch

1 batch

2 batch

3 batch

4 batch

5 28.5 % 29.1 % 28.5 % 27.8 % 28.1 % Encapsulation rate Size distribution by intensity 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. A broad spectrum of analytical methods has been established for this purpose. Polymun produces GMP material including all necessary documentation for IMPD/IND. We assist in planning and implementation of clinical trials. Finally, 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. Different encapsulation techniques are employed, depending on the nature of the drug. Hydrophilic substances are passively entrapped. Amphiphilic substances are actively loaded and hydrophobic drugs or membrane proteins are incorporated into the membrane of the liposomes. 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 Polymuns own technologies, non-proprietary?technologies and existing customer processes can be?implemented. Advantages of liposomal formulation 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. 苏州微流纳米生物技术有限公司 进口均质机、脂质体挤出器、激光粒度仪 www.willnano.cn TEL :