Standardization in business requires us to take a step back from the belief that our technology and processes are unique and require specialized tools or environments. The revelation that significant efficiencies can be made in both time and cost when customization is reduced suggests the industry is developing a more pragmatic approach that will ultimately benefit patients.
Product managers in all industries, from food service to commodities, have learned that an N=1 approach to development or production is not always good for business.
The increasing scrutiny over the cost of biopharmaceuticals, combined with the need to bring life-saving therapies to emerging regions, requires businesses to balance social and financial needs, while driving patient access. Standardization is one tool that is essential to building a successful global business strategy.
“Standardization means moving away from customized solutions toward more off-the-shelf, platform approaches. Everyone in the industry likes to think their product is special, but in many cases it should be possible to use a configurable, but standardized option,” explains Olivier Loeillot, general manager of bioprocess at Cytiva.
“Consider monoclonal antibodies (mAbs). While they require sophisticated technology and manufacturing processes, many of them already use similar production platforms, so adopting a standardized approach should be fairly straightforward, using standardized equipment or processing environments based on single-use technologies. Today, there are even pre-fabricated modular facilities available for mAb manufacture.”
Given the complex nature of biopharmaceuticals, there will always be products that are unique from a manufacturing point of view. Some products will require more specific technology (vaccines often fall into this category), while for newer modalities, like gene therapies, the industry is determining the optimal platform process, so standardized solutions are a way off. But most products are actually not that differentiated from a manufacturing point of view, and this is actually a positive.
You may not want to be special
For Pfizer, the idea of standardization became increasingly important after an experience in China. “The domestic markets of the US and Europe are often driven by the same types of products, but for the emerging markets, we needed a completely different approach to make our life-improving biologics and vaccines available to people who need them,” says Matt Roberge, senior director, global technology and engineering, at Pfizer.
Roberge and his team learned an important lesson. The pharma industry can use fantastic science to make fantastic products that require specialized manufacturing. But it’s all for nothing if the product doesn’t reach patients.
“There is a growing realization that heavy, stainless steel manufacturing plants aren’t responsive to change – they take a long time to build and can introduce inefficiencies when it comes to transferring projects from one site to another – something that is more likely to happen as governments express an increasing preference for local manufacturing,” says Roberge.
In addition, the manufacturing process and associated parameters are linked to clinical trials; when moving the process to another location, it must be replicated exactly. This is where standardization across sites becomes important.
In many cases, companies also need to scale down manufacture. It is traditional to manufacture products in very high volumes at a low number of plants, but if companies want to produce locally the market will be smaller, necessitating smaller production volumes.
“Many aspects of pharmaceutical development today are customized, with different approaches, processes and equipment often being used for different molecules, which adds to the final price,” adds Loeillot.
“Customized solutions inherently have a number of disadvantages. The biggest is the time needed for a solution to be developed and delivered, which can be significant, and the R&D work required means higher costs than off-the-shelf solutions.” In addition, once the solution has been developed, there will always be a risk of shortage, as it will only ever be produced for one customer by one supplier.
Medicines for all
Pfizer has now started to adopt standardized approaches where possible, and this has not only benefitted patients – who are now gaining access to new medicines – but has also benefited the company in creating new options to help meet the ever-evolving needs of the global healthcare industry.
“As just one example of how standardization has benefitted the company, one of our development functions used standardization to decrease the time involved in some formulation steps, without impacting safety, quality or compliance,” says Roberge.
For every product, the team would pick a new vial and stopper design, which involved different studies each time. It took about 18 months to optimize the design for each product coming through the pipeline. In time, a standard platform was implemented, so scientists used the same selection of components and manufacturing processes.
“This change was an adjustment, but the timelines went down to a fraction of what they had been, so they saw the advantages and how much it freed them up to pursue additional projects,” says Roberge. “At the start of the drug development process, there will always be a need for flexibility to allow scientists to be truly creative, but as a molecule advances, there is a real opportunity for standardization.”
There will always be those wary of standardized approaches. Consider the journey of single- use systems; when they first emerged, some companies were reluctant to use them. “In time, they became well accepted as a standard solution in biopharma manufacture,” says Loeillot.
“It is also important to point out that a standardized solution does not mean a ‘rigid’ solution; even with a standardized approach, there will still be options to configure for different molecules – and it can be more flexible than hard-plumbed stainless-steel infrastructure.”
Roberge suggests a lesson from history. “I once heard a micro-economic theory, which I think is very relevant to the pharma industry,” he says. “Many years ago, the Queen of England was the only one wealthy enough to purchase expensive silk stockings handmade by a craftsman. The profit made by the craftsman was limited because he was only selling one pair at a time. When someone figured out how to make those same silk stockings on a machine, for very little cost, the market opened up – many more people now had silk stockings, in a huge variety and a large industry was born.”
Applying this to pharma, Europe and the US are the Queen – only they can afford medicines (and even then many people in those countries still need better access), and the rest of the world’s population cannot.
Standardization will not work for every single product, but applied in different ways throughout the industry it could make a big difference. Those who can find a way to make drugs cost less, while addressing new medical challenges will exist in the future, because they will have figured out how to make a difference in the lives of billions of people.