CPHI FRANKFURT REVIEW di Tomba . This will double its capacity , both in generics and CDMO arena , while also enhancing operational safety and isolation technologies , the company said .
Likewise , Quotient Sciences completed the expansion of its drug substance manufacturing facility in Alnwick , UK . The £ 6 million expansion delivers multi-purpose capacity of up to 15 GMP reactor streams with reactor volumes ranging from 5 to 150L and tactical deployment of batch or continuous flow chemistry technologies to optimise manufacturing processes .
Univar Solutions announced the addition of four pharmaceutical ingredient labs at its ‘ solution centres ’ in Houston , Texas ; Osasco , São Paulo , Brazil ; Mexico City , Mexico ; and Essen , Germany . They will provide services such as formulation and prototype development , performance and application testing , chemical and product performance analysis , and custom blending for various dosage forms including oral solid dose , semisolid , liquid and topical .
Finally , Symeres acquired Exemplify BioPharma , another USbased CRO just before the show . Exemplify provides integrated drug development services in process and analytical chemistry and formulation development from a 1,750 m 2 site at Cranbury , New Jersey . Earlier , Symeres had acquired Organix , a supplier of lipids for mRNA therapeutics and vaccines in the Boston area . ●
A ‘ revolution ’ in continuous processing
Following launch at a symposium in Boston in September , Ampac Fine Chemicals ( AFC ), an SK Pharmteco company , has developed a new series of skid-based modules for continuous flow processes . These , it claims , will revolutionise the technique , closing the gap between benchtop development with microreactors and manufacturing scale .
Both AFC and SK Biotek have been active in continuous processing for many years in areas such as cryogenics , oxidation and SMB chromatography , but almost always at large-volume scales . Historically , the technique has been difficult to implement at small scale and during the early stages of drug development , when pharma companies want to get their clinical material in quickly , regardless of what the best or cheapest process is .
Each of the modular units is fully qualified and can be stacked on top of each other and connected up , delivering the exact process conditions the chemistry requires , said Bill DuBay , VP of global R & D , speaking to SCM at CPHI Frankfurt . Thus the cart can be built up for specific reactions , work-up , separation or distillation , with the process built piece-wise into it .
They units – as yet , they have no brand name - can typically produce 5-20 kg / day of API for clinical phase programmes , much faster than batch processes . All of them are of the same height , width and depth , DuBay added . “ Once you are done , you clean the unit operation , take them apart and reassemble them to go into the next process .”
Each module has its own interface , with an input-output plug that goes directly into the cart . The built-in computer can recognise which building block it is and the order it is in , so that the whole set-up can be operated manually based on in-house developed software . The whole skid can fit within the space of a kilo lab .
Ampac ’ s new continuous flow skids
The carts can be reconfigured in a matter of days once each of the modules are built . It takes weeks to put together a new or different module but once available it can be readily reconfigured as multi-product equipment , DuBay added . This means lower capex costs and avoiding the problem of the long lead times required to build dedicated skids , which has also often hindered the adoption of continuous processing in the early stages .
Scale-up for production in dedicated continuous units is said to be straightforward and inexpensive . According to Dubay , the concept is unique to AFC among CDMOs , though some Big Pharma companies , notably Eli Lilly and Novartis , have developed similar ones within specific projects .
The company is currently carrying out a demonstration project with a four-step process for an unnamed API within three kilo-lab hoods at its site in Rancho Cordova , California . It is also now working out what the opex savings are relative to the same process in batch .
Plans are to move the process , once ready , to its other site in Virginia and run them with its partner Phlow , a public benefit corporation focused on essential medicines . “ We will continue to build up our library of modules as we develop other APIs ,” said DuBay . “ We are also looking at scaling the carts up or out as we move to a bigger scale .”
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