StemCell Therapy

This fast-evolving field uses nanoscale or nanostructured materials to impart unique pharmacokinetic and therapeutic effects such as enhanced dissolution rate and oral bioavailability, targeted delivery, enhanced efficacy and reduced toxicity.

The control of materials in the nanometer size range requires scientifically demanding chemistry, analysis and manufacturing techniques. Our nanomedicine expertise encompasses formulation, process and analytical development, GMP manufacturing and dossier development.

We are experts in the following formulations:

Once we identify a suitable formulation, our scientists develop phase-appropriate production processes in accordance with cGMP and mitigate technology transfer issues by using the same teams for development and manufacturing.

Techniques include:

In our cGMP-compliant manufacturing facilities, we can produce volumes of a couple of millilitres to multiple litres, using batch-type and continuous-flow processes. We also work with highly-potent drug substances and can deliver nanosuspensions and nanoparticle solutions as sterile finished drug products in vials or syringes.

To support product development and to perform quality control of GMP-produced drug products, we utilise state-of-the-art analytical techniques such as:

Having advanced a wide range of nanomedicine formulations into the clinic, we are used to developing new manufacturing techniques and analytical procedures under fierce regulatory scrutiny. Our understanding of the regulatory landscape gives your nanomedicine project the greatest chance of approval.

Read the original:
Nanomedicine | Ardena

This entry was posted on April 14, 2019 at 8:46 am and is filed under Nano medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |