Does this affect our industry?
Now is a time of change in many areas. These changes affect the way that we design and operate our facilities to a significant degree.
The worldwide recession brought with it changes in company fortunes which mixed with an on-going rebalancing of global wealth, together with a decline in the product pipeline, have combined to place significant challenges on the traditional pharmaceutical companies, “big pharma”. They have been further challenged by the generic manufacturers and the CMOs with this declining pipeline as products come off patent making a focus on cost of goods inevitable; a condition that has affected OSD products for some time and now, of course, includes challenges from bio-similars. Further, new product is emerging that is developed in different forms and by significantly different means than the API/chemical excipient processes of “traditional” chemical based products. Likewise, the advances in capability to increase titre mean that the biologics manufacturers have the opportunity to rethink their manufacturing processes.
There is inevitably an issue with development cost and the effort and expense in relicensing products has been prohibitive. This tends to mean that changes in process have to be hard fought or just not worth consideration. This has stood as a barrier to new development for each of the three enterprise formats.
This has meant that we have been tinkering with continuous processes and closed processing for some time without getting serious about the implementation of either, with some notable exceptions. This has made sustainable options difficult to achieve as open or semi-closed product in large, cumbersome facilities based on equipment responding to old, yet admittedly tried, chemical formulae or biological set-ups dating back in the case of the former to the late 19th or early 20th centuries; or the latter to just post mid-20th century is still the norm for much of our industry; as are open fronted fume hoods/cupboards in research.
There is now the opportunity, whether it be in R+D, development research, CT, scale-up, OSD, biopharma or OTC, through taking a leading role in the on-going science, technology and sustainability revolution available through developments both within our own and transferred from other industries providing significantly greater operational flexibility than that available through traditional laboratories or batch manufacture and the opportunity for, once in place, significant sustainable cost gains throughout the process. Not the least these include:
- new principles of chemical design for manufacture through the use of QbD principles
- new materials and manufacturing methodologies making process closure and/or continuous operation more accessible:
- smart engineering plastics as metal replacements providing smarter, simplified valving system’s and smooth bio-safe connections
- improved equipment production techniques and design practices providing more ergonomic interfaces and safer accessibility
- opportunities for integration of smarter isolation systems allowing system closure as secondary , or even tertiary, containment reducing the need for further room containment
- increased automation and robotic options, when linked with PAT identification and characterisation, allowing rapid, controlled, quality assured transfer of product from one process stage to another
- smaller, modular, flexible equipment set-ups and rigs providing the opportunity for greater interaction with the world at large
- smarter and more visible control systems allowing more portable interfaces
- an enlightened approach to operations through the availability of additional metrics and quotas; i.e. no longer just a financial bottom line, but sometimes an energy or emissions budget in kWh, CO2, etc
Many of the above are accessible to all stages of drug development from the R+D laboratory through to warehousing and packaging operations providing a more sustainable approach.
There is always a cost to join, but when linked with a more open risk-based regulatory environment and with new sustainability-based parties to whom companies are accountable – some are voluntary, such as rating system reviewers and internal corporate sustainability managers, and others mandatory, such as regulators and energy code officials – mean that engaging with a more sustainable approach to design, implementation and operation is not only feasible but available and increasingly necessary.
What does that mean in engineering and architectural terms?
Other than our obvious engagement in the above as designers and engineers of systems, as operational engineers and architects involved in pharmaceutical process and facility design, engineering and maintenance we are members of a global industry that, for all the right and wrong reasons, needs to respond to the commercial pressures of drug discovery, development, and production.
So we have a set of choices – follow the mean and achieve sustainability by legislative default or engage up front in ensuring that we achieve significant improvements ahead of the game. Throughout the drug product supply chain from the way we design facilities, including the settings we place them in, to the processes we use to produce, manufacture, package, store, receive and export use of sustainable options provides overall gain.
An extract from an article for Pharmaceutical Engineering