Accelerate Your Biologics Clinical Tech Transfer and Supply
For your liquid or lyo products in vials in as little as five months
The Program
The Fast-Track Tech Transfer Program is suitable for injectables biologics drug products
- In any clinical phase
- In vials both as liquid or lyo products
It is also suitable across various modalities including:
- Mammalian-derived
- mAbs
- Bispecifics
- Scaffolds and other recombinant proteins
- Fc-fusion proteins and Fabs
- Microbial-derived
- Non-potent bioconjugates
Accelerate Your Timelines
The program gives you access to a leaner tech transfer scope that enables speed and enhances risk mitigation.
The tech transfer program is powered by our team of experts with a strong tech transfer experience, with more than 50 biologics drug product tech transfers successfully performed in the past 12 months.
Our team of experts are enabled by latest manufacturing technologies with a high degree of automation as well as by Lonza data-driven platforms for manufacturing processes, container closure systems, and analytics.
Minimize Your Regulatory Risk
Our Swiss state-of-the art manufacturing network is at the forefront of Annex-1 compliance.
The sites have a proven-track record of inspections from the main regulatory authorities. We are equipped with filling lines with isolator technologies and with Single-Use-Systems (SUS). Benefit from our comprehensive in-house quality control testing panel.
With our 100% success rate for IND-enabling CMC modules, our regulatory experts are here to support you in minimizing regulatory risk and achieving success for your regulatory filings.
Optimize Your Drug Quantities
The Fast-Track Tech Transfer Program enables you to optimize the drug quantities of your valuable biologics drug product.
The required drug substance quantities are reduced based on a lean tech transfer approach leveraging the Lonza data-driven platforms. At the same time, the drug product yield from the filling process is maximized thanks to our optimized processes and low loss line features such as 100% in-line weight check-in.
Get Access to World-Class Development and Manufacturing Support Expertise
At our Basel Center of Excellence, you can access a full range of specialized innovative services tailored to your needs and product phase. You can optimize your formulation, process or analytics for your liquid or lyo product in high or standard concentrations. You can address comparability as well as test in-use clinical administration.
In addition, you can get access to quick resolution of particle investigations throughout your development or manufacturing through our Forensics-On-Demand Program or perform extractable and leachables studies.
