The Role Of The Contract Manufacturer In Medical Device Development

By Maria Barajas

Introduction
The emergence of biologic drugs and patient-friendly delivery methods, such as pre-filled syringes and auto-injectors, are necessitating early, close collaboration between drug delivery system manufacturers and their pharmaceutical and biopharmaceutical partners.

These new therapies require innovative packaging materials to avoid adverse chemical interactions and accommodate higher volumes. Additionally, temperature-sensitive drugs require storage solutions that not only meet the needs of the drug product, but also ensure compliance with regulatory guidelines in a properly monitored and sustained environment. Any deviation from the ideal environment can affect patient safety and jeopardize the drug’s quality, resulting in loss of potency, efficacy or even the need to discard the product entirely.

To that end, more than ever, device contract manufacturers must deliver continuous innovation and flexibility to accommodate the delivery of a wide range of drugs throughout each therapy’s lifecycle. Such partners—either through the development of proprietary technology or adapting existing platforms and offerings—should deliver innovative products and institute processes that offer pharmaceutical companies the opportunity to deliver a safe, effective and easy-to-administer therapy to market.

Ensuring Quality, Patient-Centricity and Scalability—Key Considerations in a Contract Manufacturing Partner
With the continued introduction of biologic and other complex, sensitive therapies, it is critical for pharmaceutical companies to partner with forward-thinking contract manufacturing organizations that have the needed experience and expertise readily available to adapt to diverse therapeutic portfolios. Whether developing a proprietary delivery platform for a new drug or customizing an existing technology, device contract manufacturing partners must be capable of serving pharmaceutical partners in the following ways:

• Strong program management practices: Program management execution is all about managing risk and providing solutions. The ability to anticipate unmet needs and provide a roadmap for success is critical. The program kick-off meeting will likely uncover challenges that may not have been obvious. It is critical to take whatever learnings arise from the program kick-off meeting and apply them to the project plan.
• Understanding regulatory requirements: For a combination product to go to market, it must meet a number of regulatory approvals, especially if launched globally. Many new delivery platforms include electronics, which must meet standards outside of the pharmaceutical industry. Additionally, new regulations are consistently being written for new products, often after development is well under way, so it is important for drug delivery manufacturers to have a working relationship with regulators to keep on top of changes and adjust manufacturing processes and plans accordingly.
• Building in quality from the start: Patient safety is at the forefront of consideration in the pharmaceutical industry, with regulatory agencies requiring drug makers to develop and institute quality processes in manufacturing. As a result, expectations for quality from end-users is exceptionally high. Contract manufacturers share in this responsibility to make sure the drug delivery platforms they produce meet the highest possible standards. Forward-thinking and patient-centric partners provide the ability to implement and refine Quality by Design (QbD) processes. A QbD approach delivers an improved, data-driven output that provides manufacturers with superior product and leads to a process that allows stakeholders to better understand risk and strategies to minimize it.
• Identifying scale-up capabilities: If a pharmaceutical company has what they believe to be a blockbuster drug, they will want to understand their delivery product partner’s supply chain from top-to-bottom, to make sure that operations can keep up with capacity, offer a global footprint and avoid any security of supply risk. This includes thoroughly assessing every aspect of on-site assets – including tooling, equipment, facilities and clean rooms – to ensure scale-up demand can be met. Their contract manufacturing partner should help identify any areas that may be of concern to the drug company and point out any areas that may impede accurate volume of production.
• Drug handling and cold chain storage: Drug products such as biologics, vaccines, and products whose chemical and physio-chemical stability depends on temperature put an added emphasis on pharmaceutical manufacturers to ensure proper handling, storage, transportation and dispensing. It is critical that a contract manufacturing partner can provide proper cold chain solutions – helping to ensure that temperature-sensitive drugs are delivered to the patients who need them without compromising the integrity, efficacy, safety or security of the drug.

As more complex therapies like biologics and biosimilars fill the drug pipeline and come to market, collaborating with a contract manufacturing partner with a deep bench of expertise across containment, delivery and manufacturing can provide multiple benefits. While showing great promise for patients, advanced therapies are complex and nuanced, and the trend toward self-administration makes continued innovation all the more critical. With a trusted contract manufacturing partner, pharmaceutical companies can ensure that their innovative therapies can come to market efficiently without compromising the quality and the safety of the drug and its delivery system.

About West
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world’s pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West’s 2016 net sales of $1.5 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.