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WuXi Biologics non-GMP pilot plant (NPP) was established in September 2011. Located in the Waigaoqiao Pilot Free Trade Zone, Shanghai, it has 1,400m2 clean suite space and offers the following capabilities:
The NPP Shanghai site (NPP-SH) has 600m2 upstream non-GMP clean suites and 800m2 downstream non-GMP clean suites. It is equipped with a variety of state-of-the-art process equipment including:
100% disposable/single-use elements from the seed train to production at all scales.
Since its foundation, the NPP Shanghai site has successfully completed over 500 batches of non-GMP drug substance for over 260 projects with over a 99% success rate. The pilot plant has a demonstrated production capacity of 100 to 120 batches per year.
Since its establishment, the NPP Shanghai site has delivered over 500 batches of drug substance for over 260 projects with the successful rate of over 99%.
NPP-SH has delivered over 260 projects with the products covering a variety of molecule types. Besides monoclonal antibodies, which comprise the majority of products produced at the site, and increasing number of other products are being manufactured that include mAb intermediates for ADC drugs, bi-pecific antibodies and Fc-fusion proteins. Moreover, the downstream technical platform is capable of handling a wide variety of recombinant proteins, including polypeptides, Fabs, membrane proteins and enzymes.
NPP is capable of handling a variety of biopharmaceutical molecule types.
Process scale-up is one of the key roles of the non-GMP pilot plant. At WuXi Biologics, factors including consistent power over volume (P/V), oxygen transfer/utilization rate (OTR and OUR) and alignment on the timing of turning on the micro-sparger between different scales etc., are taken into consideration during cell culture process scale-up. Empirical platform experience, together with scale-up calculation tools built upon kLa models of various bioreactors, are employed to ensure smooth technology transfer and successful scale-up of processes from PD scales to 50 L and up to 500 L scale. In addition, comparability of productivity and product quality attributes between the two scales are evaluated.
Using perfusion in N-1 seed expansion is widely used in the industry to realize process intensification and different modes of the production culture. Using a rocking bioreactor for N-1 perfusion process has additional benefit over a stirred-tank reactor coupled with a cell retention device.
With a rocking bioreactor for N-1 perfusion culture, the last few stages in a typical seed train can be combined into one and some stirred-tank reactors can be saved.
Raman spectroscopy offers non-destructive, continuous, real-time measurements to monitor the performance during cell culture, thus providing a good PAT tool for biologics manufacturing. At the NPP, multiple case studies have demonstrated that Raman spectroscopy can be utilized together with existing bioreactor controllers to realize automatic control of a perfusion culture.
In-line dilution with ÄKTA is widely used in the biopharmaceutical industry, to enable easier purification processes and buffer preparation and improve efficiency.
This technology can also help to improve capacity, realize cost saving and easier buffer delivery.