Given the estimated $1 billion1 price tag of bringing a drug to market, biologic and pharmaceutical manufacturers increasingly rely upon single-use aseptic processing systems for more flexible, reliable and cost-effective operations.
Too often, though, individual manufacturing sites within large, multinational companies develop and execute their own approaches to single-use processing. This creates redundancies and inefficiencies that slow product launches, unnecessarily stretch internal resources, and affect quality and reliability.
Fortunately, a few adjustments in how global teams operate can yield appreciable improvements in single-use processing across an organization.
Balancing global and local operations
To better serve global markets, manufacturers continue to set up facilities closer to the local markets they support. This trend offers obvious benefits: speed, particularly related to ship times; familiarity with the specific needs of local and regional customers; and compliance with applicable regulatory considerations. The move away from centralized manufacturing, however, presents its share of challenges, as evidenced by the following real-life anecdote:
Three separate engineering teams within a global manufacturing company were simultaneously performing the same single-use connector study to evaluate extractables and product performance. The groups in North Carolina, Germany and Singapore were unaware of their overlapping efforts until a shared external supplier notified them. Each effort had its own timelines, facilities and risk analyses — circumstances unlikely to deliver improved speed, costs or productivity.
Other factors impede global efficiency, too. Regional manufacturing operations often face a lack of highly skilled, experienced employees familiar with the industry’s latest advances. Single-use technology (SUT) has been used at manufacturing scale for only the last decade. Single-use systems (SUS) in GMP also continue to grow, but limited SUS knowledge among local workforces sometimes drives local manufacturing operations to reinvent the wheel. Each new process or technology takes time to debug and can contribute to delayed product launches and greater exposure to risks such as contamination in the drug manufacturing process.
Relying on previously validated processes from other sites saves time and costs while mitigating risk. Leveraging this experience, however, requires knowing it exists within the company or through its partners.
Know your experts
The first step in streamlining the development and implementation of global standards is to identify subject matter experts (SMEs) both within and outside the organization.
Start by creating a list of internal SMEs by area of expertise and site. Then, produce an additional SME list comprised of external resources. The knowledge and experience of vendor-partners is often underutilized. For example, process manufacturing teams can easily save two to 10 weeks on component design and engineering reviews simply by using existing vendor drawings and part numbers. External SMEs also are a resource for performance testing data and in-depth material characterization. Typically external partners have already optimized their products and systems for ease of use, system efficiency and flexibility, and compliance to GMP parameters such as sterility.
To share this collective knowledge, drug manufacturers should develop a searchable, company-wide database of SMEs, technical specifications, historical research studies and outcomes that is accessible to scientists and engineers.
A community of practice
Communication and collaboration are greatly enhanced by creating a “community of practice” — a group of SMEs from multiple locations and with specific backgrounds. Team members regularly share new technologies, best practices and challenges by site or project.
Again, highly qualified suppliers should be considered integral members of the SME community. Close collaboration between companies and their vendors streamlines the development process and increases the likelihood of success. Some suppliers offer no-cost engineering expertise and assistance as an investment in a long-term business relationship. This saves money and mitigates risk by using solutions already tested and proven to perform in existing applications.
Suppliers versed in relevant ISO standards also can manage the design controls process and provide documentation indicating the finished component meets company and regulatory requirements. Process controls — like installation, operation and performance qualification (IQ, OQ and PQ) validations — seamlessly enter the design history file, which keeps projects moving along. External resources also bring useful perspective gained from working with multiple companies, and they allow internal resources to focus on other matters.
Industry organizations are another excellent source of information. Committees of the Bio-Process Systems Alliance (BPSA), for example, have addressed best practices for major categories of single-use technologies. Experts from BPSA member companies have developed consensus guidelines on quality test methods related to key performance attributes of single-use technologies. Output from these collaborative efforts includes descriptions of testing options, recommendations on testing frequency and summaries of available test references and industry standards.
Internal agreement within a company regarding which industry standards to follow will support continuity across the organization. Of course, local circumstances — unique regulatory requirements, for example — sometimes impact costs or timelines in a way that is too burdensome to ignore. A common-sense willingness to deviate from standard practice when necessary is important for optimized manufacturing.
Streamlining for success
Single-use processing continues to expand, particularly in emerging markets. Rapid growth presents one more argument for better communication, collaboration and standardization within companies and the industry.
Harmonization across global single-use processing operations delivers the efficiencies, cost savings and quality critical to the success of pharmaceutical companies today and into the future.