As outsourcing becomes the norm across the pharmaceutical manufacturing landscape, the complexities and considerations associated with the increasingly unique drug products on the market today have made choosing a CDMO partner more difficult – and more critical – than ever.
When looking for the right CDMO, pharmaceutical companies can help ensure their project’s success by focusing on five primary attributes in their potential partner: quality, flexibility, speed, cost-effectiveness, and experience. By evaluating a CDMO’s track record, understanding its internal processes, and gauging its willingness to conform to the processes and procedures of its clients, pharmaceutical companies can make informed choices and achieve better outcomes as a result.
The Five Key Attributes Of A Great CDMO
With hundreds of CDMOs of all different shapes and sizes to choose from, pharmaceutical companies can find themselves struggling to determine the right fit for their needs. Establishing a framework for vetting CDMOs can be the first step to success; by focusing on the attributes that distinguish a CDMO from its competitors, pharma companies can avoid the delays and pitfalls that can lead them right back to square one. Some of the most important things to look for in a CDMO partner can be found by emphasizing these five traits:
Of the five core characteristics a pharmaceutical company should hope to find in a CDMO partner, a demonstrated focus on quality is the most important. Manufacturing partners can be fast, or comparatively inexpensive, or willing to incorporate any number of workarounds to make a project feasible, but if the final drug product falls short of commercial or regulatory quality standards, the rest of that equation ceases to matter. Every decision surrounding a manufacturing process has to be undertaken with the end product’s quality in mind, from what equipment to use to which people to hire, before looking at how to save time, spend less, or move faster.
Applying the concept of flexibility in the pharmaceutical space is, itself, flexible – it can affect timelines, packaging, workflows, and processes, and can extend across business units and functions. To accommodate a range of customers, products, and processes, CDMOs must be flexible in not just how they work, but how they collaborate; adapting to a customer’s quality management systems, working with their various teams, or learning to communicate according to their specific needs are all core to achieving flexible, optimized workflows.
Speed is a critical facet of a CDMO’s value proposition for customers, and having the right speed for the right product and volume is the recipe for optimized scalability. From manual assembly to semi-automated and fully automated lines, employing the right speed to suit the product, the market, and the customer need is crucial. But this applies to more than manufacturing processes; having the project management tools and systems that allow a project to go from kickoff to parcel in months instead of years is equally important. Conversely, the ability to pace a project appropriately can be equally important – finding a CDMO that can balance speed and optimized supply chain management, staffing, and process times can be just as critical as achieving an accelerated commercial launch.
When it comes to cost-effectiveness, CDMOs should be positioned to leverage process analytical testing (PAT), including in-machine inspections, verifications, and non-destructive testing to control expenses. Being able to verify, using data, that an assembly is correct throughout the course of a process rather than at the end reduces risk at final release testing, marrying quality and cost by eliminating waste and lessening labor. While many pharma companies may be keen to select the CDMO with the lowest cost estimate, this inclination can end up costing them in the long run. It’s important to be deliberative when comparing proposals, particularly if one stands out as markedly inexpensive when compared to the rest. How comprehensive is their plan? Is there the potential for multiple change orders? Does it truly meet every one of the project’s goals? Understanding the rationale behind the price tag is important to choosing the most economical CDMO rather than the cheapest one.
While quality is the most important consideration when choosing a CDMO, the most important clue in determining whether a manufacturing partner is capable of achieving the quality and scale needed to ensure the success of a project lies in its experience. Having both long-standing and varied experience – encompassing a range of therapeutic modalities, delivery systems, packaging options, and scales – can be invaluable for pharma companies, particularly ones that lack the financial resources to accommodate rework.
PCI’s Value Proposition For Customers
At PCI Pharma Services, these five attributes are all part of its comprehensive approach to contract manufacturing. To ensure quality, PCI works to lower the defect rate of products by conducting more early testing and trials using placebo or water-filled syringes. Another key means of improving quality is to reduce handling, and to this end, PCI employs in-line processes from primary packaging/assembly to the carton and into the shipper, minimizing the potential for loss and streamlining manufacturing. Finally, one of the most important aspects of PCI’s approach to quality is in its early process drift detection. By performing frequent machine inspections and assembly verification, as well performing testing as often as hourly rather than at the end of the batch, PCI is able to identify process drifts before they result in defects.
A key component to ensuring flexibility for PCI has been in creating multiple formats on one machine or platform, allowing users to shift between processes rather than have dedicated lines for each. This machine flexibility, when combined with an array of machines capable of performing a wide variety of processes, allows CDMOs like PCI to offer quick start-up and streamlined scale-up, both of which are valuable for customers at every phase of development. Equipment like PCI’s auto-injector assembly lines, which can transition between producing three separate makes of device with streamlined retooling and changeover, are just one example of the access to resources customers are afforded to meet the demands of their manufacturing paradigms.
In providing a one-stop-shop for customers that allows them to scale up seamlessly, PCI offers solutions to fit nearly any manufacturing scenario. Its Biotech Center of Excellence, which was recently expanded through major capital investment, represents PCI’s commitment to creating more manufacturing capacity to support the expanding biologics space. PCI combined partnerships with leading suppliers with increased high-speed automatic syringe assembly and labeling, vial labeling and cartoning, and auto-injector assembly to revolutionize its capacity and flexibility. These improvements were coupled with building out existing cold storage capabilities and leading-edge manufacturing suites to create a comprehensive, state-of-the-art manufacturing and packaging facility.
PCI understands that by the time a customer has reached the packaging stage they are eager to finally bring a product to market, making the speed of both manufacturing and management integral to bringing their therapeutics over the commercial finish line. PCI is experienced in scaling products within highly constrained timelines; for one of its recent projects, related to vaccine production, PCI was able to scale up to commercial production within six months of receiving the order. Its ability to achieve the necessary speed to facilitate such quick turnarounds is the result of PCI’s focus on quality and flexibility, coupled with its extensive experience. With facilities around the globe and leading expertise in a range of packaging options, PCI can offer customers packaging that is more economical, more environmentally benign, and even more patient-centered.
PCI has designed packaging options in the past to help facilitate self-administration of injectable medication for patients with arthritis; its experience in designing packaging that goes beyond traditional expectations can help customers realize additional value for their products in a regulatory atmosphere that places increased emphasis on patient acceptance and adherence.
While all of these factors – quality, flexibility, cost-effectiveness, and speed – help to make a CDMO competitive in the current market landscape, it’s ultimately, experience that allows PCI to avoid past pitfalls and delays. Being able to perform equipment assessments and device selection in conjunction with device manufacturers is key to helping customers make data-informed choices regarding component selections and have design input throughout the process. Ultimately, the earlier that a CDMO like PCI is brought into the process, the more customers can leverage its expertise to avoid issues and create opportunities to be proactive.
By Alex Weaver, Sr Director of Engineering, PCI Pharma Services