Formulation development
Analytical method development
Process
scaling
We offer the development of encapsulated drugs for all kinds of pharmaceutically active ingredients based on various lipid-based formulations such as:
The developed formations are tested in accordance with the QbD (Quality by Design) and ICH guidelines.
Our analytical services are designed to support our partners development projects, however we will support any standalone analytical project. We also supply tests, starting materials and intermediate products.
SyVento Research and Development Team is located in Cracow, Poland, where the extensive knowledge in biotechnology and nanotechnology meets the deep understanding of the business. 80% of the research team members have PhD in life sciences –mainly biotechnology and chemistry.
SyVento supplies a wide range of equipment, including HPLC (with UV-VIS, DAD, fluorescent, ELSD and MS detector), particle size and zeta-potential measurement devices, viscosity meters, freeze-dryers and spectrometer.
We offer the possibility of scaling the production of formulations based on lipid nanocarriers by transferring solutions developed in the laboratory on a semi-technical and technical scale. Thanks to the extensive equipment base, we are able to perform up-scaling starting from very small batches and up to 50L batches.
Encapsulation of messenger RNA inside lipid nanoparticles
Development of nanocarriers dedicated to various administration routes IM, IV, SC
Encapsulation of hydrofile substance inside liposomes
Development of nanocarriers to reduce toxicity, improve the pharmacokinetic profile
Liposomes as a nano carrier for an inhaled substance
Optimalization of liposomes production in accordance with the GMP standard
Liposome formulation containing a contrast agent
Development of liposome formulation containing a contrast agent
1
1A. Building a library of potential formulations
2A. Performing in vitro screening tests, including determination of the potential toxicity of excipients
3A. Selection of auxiliary substances for further research
2
1B. Determination of the key composition and critical process parameters
2B. Physicochemical characteristics of the formulation along with research on appropriate biological models
3B. Selection of the best formulations for further testing, together with the determination of key test parameters
3
1C. Refining the manufacturing process
2C. Determination of toxicity, PK, BD, in appropriate biological models
3C. Selection of candidates for the GMP scale up process.
4
1D. Production of a batches for clinical trials
2D. Conducting clinical trials / qualifying supervision over the trial
Advantages of Liposomes
Increase in efficacy and therapeutic index (eg. Actinomycin D)
Act as Scaffold for additional agents
Possibility of several routes of administration (both inhalator and intravenous)
Protect encapsulated drug from metabolic digestion
Increases half life of drug
Biodegradable, bio-compatible & non-immunogenic
Can be made into variety of sizes
Reduced dosage
Reduces systemic toxicity of drug (eg. Taxol, Amphotericin B)
Amphiphilic
Can be targeted to specific tissues or cells
Can carry both lipid & water soluble drugs
Improved pharamacokenetic effects
Can be used as sustained drug release
It helps in reducing the exposure of sensitive tissues to toxic drugs (unmodified Liposomes gather in specific tissues like reticuloendothelial system)
Passive (A) and (B) active targeting of nanocarriers. Nanocarriers reach tumours selectively through the leaky vasculature, or in other cases, where the nanocarrier size determines the retention in the tumour tissue. Drugs in the absence of nanocarriers diffuse freely in and out the tumour blood vessels due to their small size, and therefore their effective concentrations in the tumour decrease rapidly. The EPR effect is where drug-loaded nanocarriers cannot diffuse back into the blood stream due to their large size, resulting in progressive accumulation. In active targeting, ligands grafted at the surface of nanocarriers bind to receptors (over)expressed by cancer cells or to angiogenic endothelial cells. Adapted and reproduced with permission
Let’s collaborate and create quality liposome encapsulated drugs together.
Chemików 1
32-600 Oświęcim
Poland
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