September 15, 2017 PAP-Q3-17-FA-003
Major trends in the pharmaceutical industry, from the growing emphasis on evidence- and value-based medicine and patient-centric drug development to the increasing focus on niche and personalized therapies rather than blockbusters, are driving significant change. Heightened M&A activity, a concentration of core capabilities accompanied by increased outsourcing and a drive to accelerate the development and commercialization of safe and cost-effective drugs are all part of the new normal for pharmaceutical manufacturers.
Engineering/design firms have been affected as well. Successful firms have deepened their expertise by adding key personnel with direct manufacturing/engineering experience in the pharma industry and often act as consultants, providing strategic advice.1 Most have also developed new approaches that facilitate facility/process design, construction and validation through streamlining of activities. Examples include implementation of effective computer-integrated engineering systems1 and collaboration with equipment and other suppliers.
New facilities must be flexible and incorporate state-of-the-art equipment that ensures increased efficiency with reduced downtime to achieve greater productivity.2 Increased use of automation to improve quality and enable continuous processing will lead to further manufacturing improvements.3 For instance, the concept of overall equipment effectiveness is rapidly gaining importance.4 Pharmaceutical companies and their engineering/design firm partners must be skilled at acquiring and integrating equipment.5 Next-generation manufacturing strategies are becoming imperative and are at least being considered by most pharmaceutical companies and implemented by leading players.2
Like the pharmaceutical industry, relationships between pharmaceutical engineering/design firms and equipment suppliers have undergone significant change in recent years. The “old school” approach involved getting the most short-term “apparent” value for the customer from the supplier, with specifications so detailed that despite any changes in scope or other issues, the supplier would bear the cost, according to Robert L. Roy, P.E., Director, Aseptic Technology at IPS-Integrated Project Services, LLC. “This approach, however, ignored the need for pharma companies to maintain strong relationships with their suppliers for the life of the facility,” he says.
The “millennial approach” features no relationship whatsoever with the supplier. Pharmaceutical equipment is treated like commodity items, with suppliers called to provide quotes. It also ignores the tremendous complexity associated with modern pharmaceutical production requirements, including the myriad equipment features required to produce product of adequate quality and those required to satisfy regulatory demands, according to Roy. “This approach only satisfies owners that don’t understand the industry, and only temporarily, because numerous issues typically arise during start-up and transition to production that require administrative work-arounds, leading to a less efficient and more expensive operation,” he explains.
The “right school” approach involves strong relationships between engineering/design firms and equipment suppliers, so that both can be engaged early on in the equipment design process. This approach is essential because, according to Roy, equipment suppliers work with many owners and in the process distill the best and most current pharmaceutical thinking in the world. “In order to purchase and install equipment with the ‘best available technology,’ a solid understanding of the various equipment features and approaches selected by owners is required. We need to know which features are truly ‘value added’ vs. those that are overly cumbersome or costly and thereby impede efficient, high-quality manufacturing. Only by having established relationships with equipment suppliers is it possible to gain this crucial information,” states Roy.
There are some caveats, of course. Relationships between engineering firms and equipment suppliers must be cooperative and mutually respectful, states Carmine Stropoli, P.E., Director of Life Sciences Technologies with M+W Group. “Equipment suppliers need our investment and trust, and we need their equipment and trust. But beyond that, they need to nurture a continuing relationship with the buyer, and we need available information and pricing for the development of our plans and budgets, their useful insight on trends and their experience in the various installation applications of their equipment,” he observes.
Pharmaceutical facilities and processes tend to be highly complex and customized, and therefore relationships between design firms and suppliers are quite important. In addition, “process equipment and technologies continually evolve to align with the changing needs and requirements of pharma operations, methodologies and newer drug administration devices. Having a cooperative relationship with suppliers expedites information sharing and an understanding of the supplier’s capability to meet the requirements of a project, including such items as containment, continuous processing, isolation technology, robotics, real-time quality control, serialization, disposables, etc.,” asserts Stropoli.
Indeed, strong, long-term relationships are somewhat symbiotic, according to Roy. “For example, based on an engineering firm’s familiarity with each suppliers’ strengths and weaknesses, when requested by an owner, the firm can recommend suppliers best suited for the job.” Furthermore, the pace of preparing proposals, pricing, facility layouts, utility requirements, etc., requires ready information on equipment offerings from suppliers, according to Stropoli. Having ongoing relationships with suppliers helps facilitate the flow of information.
Whatever the state of the facility, suppliers should only be contacted and involved when there is at least an idea of the performance requirements for the equipment, including any integration requirements, and how the equipment may be basically arranged within a facility, according to Stropoli. “It is counterproductive to involve a supplier any sooner, but their eventual participation is valuable,” he adds. He also points out that involving suppliers in the early stages, especially for newer applications, reinforces the cooperative relationship to help roadmap the path forward for the preparation of specifications and eventual purchase of equipment.
Early engagement when enough of the scope is defined to have productive discussions, and outlining the need and bidding process that will be undertaken to consider and evaluate the offerings of the supplier are essential for developing successful relationships. Design firms must also treat suppliers fairly and objectively.
For instance, Roy notes that suppliers need reasonable turn-around times on quotations, and design firms must be mindful of supplier workloads and availability. “Treat the suppliers like you would treat yourself,” is his recommended approach. Suppliers should also not be used for check-price bids. They will quickly become aware of this tactic and the relationship will sour, according to Roy. From the design firm’s perspective, responsiveness is an essential supplier attribute. “We see responsiveness as part of these give-and-take relationships that when at their best can be highly productive and worthwhile for both parties,” observes Roy. Stropoli adds that proposals should clearly address the items contained within the specifications relative to performance requirements, testing, installation and scheduling.
Engineering/design firms and equipment suppliers alike are aware of the regulatory, pricing and competitive pressures facing their pharmaceutical industry customers. They are working closely with buyers, regulatory bodies and one another to develop solutions that will meet the needs for accelerated, efficient, safe and high-quality manufacture of the complex drug substances and drug products of the future.
Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.