Improving The Production of Pegylated Pharmaceuticals – Quadro Ytron
BACKGROUND / REQUIREMENT
An international Biopharmaceutical company was looking to effectively wet and disperse Activated PEG into WFI water in support of the development of a PEGylated pharmaceutical. PEGylation, is a process of attaching the strands of the polymer PEG to molecules most typically peptides, proteins, and antibody fragments, that can help to meet the challenges of improving the safety and efficiency of many therapeutics. PEGylation, by increasing the molecular weight of a molecule, can impart several significant pharmacological advantages over the unmodified form, such as:
- Improved drug solubility
- Reduced dosage frequency, without diminished efficacy with potentially reduced toxicity
- Extended circulating life
- Increased drug stability
- Enhanced protection from proteolytic degradation
The company was looking for a way to more rapidly add and hydrate this material, in a repeatable manner, without excessive aeration. Using in-tank dispersing mixers, the hydrophilic PEG has a strong tendancy to clump, float and build-up on the vessel wall. In addition, batch to batch product variation was a concern.
QUADRO ’ S APPROACH
The Quadro Ytron® ZC Powder Disperser is uniquely engineered to incorporate and disperse extremely difficult-to-wet ingredients into a liquid stream in a single-pass. The advanced design of the ZC Disperser’s rotor/stator provides for intense shearing of the powders prior to hydration, to produce homogeneous dispersions that are completely free of lumps and “fish-eyes”. A near-perfect vacuum permits concentrations up to 35% by weight to be generated with minimal air entrainment. Because the powder is completely hydrated, yield is maximized and over-processing and wastage are eliminated compared to other in-line high shear and in-tank technologies. The ZC will typically reduce batch times by 90% and also result in average powder savings of 5 – 10%.
Following trials at Quadro Engineering and the companies R&D facility, the company purchased an integrated powder wetting & dispersing module, consisting of:
- Quadro Ytron ZC disperser, 316ss wetted parts, .48 RA Electropolished
- Integrated single use, plastic bag, powder delivery system with full recovery wash port with an integrated feed pump, flowmeter and flow control valves
- Touch screen User interface with recipe control
- PLC automation for start-up and shutdown sequencing of pump, disperser and valve components, flow control and totalizing, include bag rinse toward end of powder addition cycle.