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Drug product development
Unlock the full potential of your peptide or antibody drug with our support. Trust us to help you bring your innovative therapies to life and achieve your goals faster.
Preformulation
Discover the suitable formulation conditions for your drug candidate together, including potential excipients, buffers, environmental factors such as pH, and their maximum and minimum ranges.
1
Formulation development
Reduce potential risks and select the best formulation for your drug substance, focusing on your target product profile (TPP) before it enters more extensive testing phases.
2
Lyophilization cycle development
If there is no other way to stabilize your drug product during the target shelf life, let's develop a robust and cost-effective lyophilization cycle together. Hand in hand with your product’s formulation and characteristics let's create a suitable cycle.
3
Process development
We navigate you lay out your process and identify Critical Process Parameters (CPPs) and Key Performance Indicators (KPIs), allowing us to generate excellent process understanding and establish appropriate manufacturing steps.
4
Pilot scale-up
Need help scaling up your technology from laboratory scale to pilot scale? Make your process reproducible with us and produce small-scale batches under robust technology.
5
Laboratory transfer
Is seamless tech transfer needed from one laboratory to another institution? Or do you require troubleshooting during the process? Let’s reduce the challenges together!
6
Primary packaging selection
We support you in carefully selecting the specialized primary packaging for your product to maintain your quality target product profile (QTPP) as well as its stability.
PP
Forced degradation stress testing
To identify a drug product’s primary degradation pathways under harsh conditions or during the manufacturing process, we can design stress studies to gain better insight into the intrinsic stability of your drug under forced conditions.
DT
Product contact materials compatibility
What actions should be taken to thoroughly, efficiently, and effectively ensure product safety from the perspective of extractables and leachables? Let's map your product contact materials and their potential effect on your drug!
MC
Stability studies
We plan, review, or evaluate your stability studies and results in accordance with your product's Critical Quality Attributes (CQAs) and your needs at the current development stage.
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Contact us
Navicula Zrt.
Address: Hungary 2600 Vác, Jókai Mór utca 8.
EU TAX number: HU25980521
As your dedicated partner and R&D pharmaceutical expert, we offer comprehensive consulting services in the areas of drug product preformulation, formulation development, lyophilization cycle development, stability testing evaluation, as well as scale-up and technology transfer in the biotechnology field. Boost up your early drug development activities, reduce the potential risks and collaborate with us to create customized solutions that align with your specific needs and timeline. Additionally, we are a trusted partner in supporting late-phase development. Allow us to stand by your side throughout every step of your biotech drug product development and manufacturing process!
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