Twenty years ago, many pharmaceutical and biopharmaceutical companies viewed their drug delivery system manufacturers as just vendors or suppliers. With an increase in sensitive biologic drugs that require specialized packaging, containment and delivery needs that is changing. How the two work together is evolving in order to maintain efficacy and patient safety with new drugs coming onto the market. Today, pharma companies are looking for ways to reduce internal resources and expect more ownership of the supply chain to fall on their drug delivery system partners, including drug handling, cold chain storage, sterilization, and analytical testing. This means that it is more important than ever for drug delivery system manufacturers to maintain an efficient and robust supply chain, so they can best serve their customers’ needs and, in the end, make sure patients are able to receive the treatments they need when they need them.
Common causes for supply chain disruptions
Disruptions in the pharmaceutical supply chain happen all too frequently and, according to the American Society of Health-System Pharmacists, can lead to drug shortages that affect patient care. There are a number of scenarios that can impact the supply chain, including:
Quality issues. Over the past several years, there have been a number of disruptions to the availability of sterile injectable drugs when quality issues necessitated the slowing or stopping of production. As regulatory agencies clamp down on quality and turn their focus more toward patient safety, quality issues in the supply chain can delay securing regulatory approval, lead to costly recalls for pharmaceutical and biopharmaceutical companies or, in the worst-case scenario, potentially harm a patient.
Problems transporting sensitive drug products. For many biologics, maintaining container closure integrity (CCI) during cold storage can be difficult. Concerns about CCI failure have been raised for the storage and shipment of pharmaceutical products in rubber-stoppered vials under cold conditions (e.g., -80°C or dry ice). Cold chain products need to be packed in such a way that ensures that the required temperatures are maintained throughout their labeled shelf-life. Any deviation from the ideal environment can jeopardize the drug’s quality, resulting in loss of potency, efficacy, or even safety concerns.
Raw material shortage. Based on a number of factors, a supplier of raw materials could experience an interruption in access to the goods they provide, which causes a downstream effect. That can be mitigated by working within the supply chain to identify secondary sourcing of the material needed, choosing a supplier that carries extra reserves of critical materials or ensuring that your suppliers have business continuity plans in place before working with them.
Lack of robustness and flexibility. At times, it can be difficult for a pharmaceutical company to forecast the adoption rates of their drugs in the market, so their drug delivery system manufacturer needs to have a robust and flexible supply chain in place should there be a need for upsizing. If a drug delivery system manufacturer is not ready if and when their pharmaceutical customer approaches them with a last-minute need, this can lead to a disruption in the supply chain.
Keys to a sustainable supply line
Ensuring supply chain integrity and continuity is critical for safety and effectively meeting customers’ needs and delivering safe medicines to patients. Achieving this goal can be helped immensely by following these practices:
Be ready and think ahead. First and foremost, it is critical to make sure you have a strong manufacturing strategy to support all of your supply chain needs. To do this, the manufacturing technology has to be validated to ensure there won’t be disruptions in the process. This can mean having some redundancy in your manufacturing technology and processes so there is room in your plants to pick up slack should one location encounter issues. Another option is to keep slack in your production lines to account for any last-minute request for additional product. Doing so allows you to meet the needs of your customers as they evolve.
Regulating the cold chain. Temperature mapping, qualification and monitoring can help establish the temperature distribution within the storage area or transport. Understanding the design of the room or container – such as a truck, warehouse, reefer container, or ship – can help to locate hot and cold spots. Electronic data logging monitors the environment so that the desired temperature range can be maintained throughout the room, avoiding extreme temperatures. In the event of an emergency, such mapping can help to determine the time required for conditions to return to the specific parameters required by the drug, which in turn can help determine if the product has exceeded its temperature excursion limits and ensure its efficacy has been maintained. These measures can help ensure validation of the environment – enabling compliance with regulatory guidelines.
Choose the right suppliers. Before settling on a supplier, do your homework. Ensure suppliers focus on three areas – appropriate risk management/business continuity plans (for example, do they keep reserves of critical materials, and do they have an active dual supply strategy in place to avoid any gaps in access to raw materials?), supply chain improvement (programs, practices to reduce energy, water use, and waste), and supply chain transformation efforts to continually improve the value stream.
Build efficiency into your business system. The most sustainable supply chains have a business system in place that drives efficiencies throughout the whole process. When considering your supply chain, think about how you receive demand from customers and how you are going to supply the product to them. If you have a global network of manufacturing plants, how can you use that to your advantage when special circumstances arise? Always follow proactive capacity planning, maintain efficient scheduling within manufacturing plants, and keep laser focused on a zero-back-order mentality. When at all possible, incorporate LEAN principles into the supply chain. A more efficient supply chain reduces lead times and therefore allows you to better fill what can be quick-changing demands from customers.
Ensure open lines of communication. The success of any sustainable supply chain strategy depends on close partnerships, open communication, and effective use of data to identify trends and anticipate and address future needs. This close collaboration between supplier and vendor will help to build greater trust, as well as ensure efficiency and continuity in the supply chain.
Prioritize engineering excellence. The pharmaceutical industry and the drug delivery system manufacturers who provide it products are ever evolving. As technology develops, take advantage of it and use advances such as automation, robotics and digitalization tools for manufacturing to drive improvements in safety, quality, service and cost.
Partnering for quality
As biopharmaceutical companies continue to rely more heavily on their drug delivery system manufacturers to handle additional elements of the supply chain, closer partnerships earlier in the drug development process can be beneficial. The relationship works best when the drug delivery system manufacturer is considered an extension of their pharmaceutical partner’s operations. One best practice is for the delivery system manufacturer to find out the inventory levels, targets and consumption rates of the pharma company. By doing so, the drug delivery system manufacturer can better plan their facilities, which drives improvements in their delivery performance – measured by on time, in full customer requests met.
This can reduce lead times, and enable plants to run more efficiently. As you collaborate closely with customers to optimize the supply chain, it becomes more efficient and both companies benefit as a result. Close partnerships and enhanced communication enable costs to be driven out of the end-to-end supply chain, while eliminating extra inventory along the value chain. Ultimately, close collaboration achieves a common goal for all who work in the pharmaceutical industry – safer products being available as needed to treat those who matter most, patients.
Vice President, Procurement,
Vice President, Logistics,
Global Operations and Supply Chain,
West Pharmaceutical Services, Inc.