Cork, Ireland-based Zenith Technologies is expanding its US footprint, opening sites in sites in Oakland and San Diego, California to tap demand for its manufacturing support.
One of the highest growth areas for the firm is for its automation and workflow technologies which - according to US sales manager Mike Smith - is being driven by the shift from small to large molecule manufacturing in the region.
“Companies are now faced with converting existing facilities that were built to produce a particular drug into multi-product facilities,” he told this publication. “As a result, they need to implement more flexible automation systems and code.”
He added Zenith has so far benefited “significantly” due to its focus on the life science industry, and believes this will continue as drugmakers look to reduce their manufacturing costs in response to continued pressure to reduce their prices.
“This is creating the need for increased automation and MES [manufacturing execution systems] technologies” he continued, adding some of the key drivers have been “to increase capacity, multi-product manufacturing capability, increase in manufacturing yield consistency, decrease in batch record release time, equipment data management.”
Unlike other industries – automotive, for example – the pharma industry has been slow to install automation technologies in its processes. According to Smith, this is primarily due to the stringent regulatory requirements for drug manufacturing.
“Other industries do not have the added complexity of validated manufacturing and cleaning processes that are prevalent with pharmaceutical manufacturing.
“Once a process is validated and documented, there may be significant implications for changes, there is also a heavy consideration towards patent expiry and how many batches are produced annually for various products.”
However, he continued, this is beginning to change.
“My feeling is that the FDA [US Food and Drug Administration] has made and is making significant strides regarding understanding automation philosophies when conducting site audits. The FDA would welcome more automation and less human involvement in most cases.”