Global pharmaceutical market turnover is estimated to be $ 1 trillion (1012). Biopharmaceutical is the $ 200 billion subset where processes are characterized by:
- Need for gentle mixing, biopharmaceuticals by definition deal with living organisms (cells) and/or large protein molecules that will not survive if stirred vigorously (hence low shear mixers are required).
- Need for containment (nothing allowed to leak out) plus isolation (nothing allowed to leak in). Batches can cost millions to prepare (harvesting cells from tissues etc.) and may represent millions in revenue. Magnetic coupled mixers eliminate the leakage-prone vessel-penetrating shaft, thus keeping the good stuff in and the bad stuff out. Also, the batch itself might be harmful to humans, so that same magnetic mixer protects us from the potentially harmful contents of the vessel.
- Need for extremely sterile environments. Batches worth millions of dollars, can be ruined by a few bacteria left over after an inadequate cleaning/sterilization cycle. Equipment to be used in sterile environments has enormous requirements on cleanability (i.e. design that eliminates the risk for ‘puddles’ of product between cycles, extremely smooth surfaces where there are no ‘cracks’ for bacteria to hide). Since the products are often injected into the patient, this puts very high demands on sterility (much higher than say an oral drug). One of the demands is that once a process has been designed, the manufacturer enters a validation process to have a third party certify that all Good Manufacturing Practices were followed and that it conforms to the relevant standards (for example the ASME BioProcessing Equipment (BPE) standards). This validation takes 1-2 years and costs the manufacturer ‘millions of dollars.’