August 1, 2016 PAP-Q03-16-CL-014
Contract packaging firms that offer low cost, timeliness, flexibility and creativity, combined with assured high quality, can add real value by providing unique and differentiating solutions while allowing brand owners to focus on their core capabilities.
Efficacy and safety are no longer sufficient for new medications reaching the market today. Evidence-based medicine (EBM), comparative effectiveness research (CER), patient-centered outcomes research (PCOR) and value-based pricing are becoming key concepts in the pharmaceutical industry.1 New drugs must provide measurable value not only to patients, but to other stakeholders, including governments and insurers. Value can be determined multiple ways, such as treatment success, impact on patient health and quality of life, comparative performance, ease of use, convenience for the patient and/or caregiver, cost-effectiveness and patient adherence. Many of these factors are often determined by the choice of packaging and/or delivery method.
Indeed, pharmaceutical packaging today goes well beyond providing product integrity.1 Industry trends are also driving the use of innovative packaging solutions. Blockbusters are being replaced with small-volume therapies designed to treat smaller patient populations.2 New classes of drugs, such as antibody-drug conjugates, allow targeted delivery of very small quantities of highly potent drug substances, providing greater efficacy and reduced side effects. Inexpensive DNA analysis has led to personalized treatment. In addition, databases with comparative treatment results are providing physicians with information about which medicines should work best for any given patient.1 Rather than try to develop these capabilities in-house, many pharmaceutical manufacturers are partnering with innovative contract service providers that have the ability to create unique packaging solutions both rapidly and cost effectively.2
Outsourcing of contract packaging activities is often an economical solution for established drugs that have lost patent protection, as well as generic drugs whose manufacturers often don’t have packaging capabilities.3 In many cases, the packaging of newly launched products is also outsourced because contract packagers have greater flexibility to meet variable approval times, as well as the working experience that enables reduced launch times. Unusual, or customized, packaging is also often outsourced because it makes little sense for branded manufacturers to invest in the equipment or skilled personnel in-house. Emerging pharma companies are also reliant on contract packagers. Many drug manufacturers seek to expand their global reach through the use of contract packagers.2
In fact, contract packaging organizations (CPOs) with demonstrated experience and expertise in pharmaceutical packaging, and particularly those that have a history of developing innovative solutions, are seen as important partners in the development and lifecycle management of drug products. Of the 600 buyers of outsourcing services surveyed for the 2016 Nice Insight CDMO Outsourcing Survey,4 nearly 60% indicated that they outsource clinical and commercial scale primary packaging services, while 43% and 35% of respondents outsource clinical and commercial scale secondary packaging activities, respectively. Specific services most often outsourced include labeling, controlled room temperature (CRT) packaging, packaging design and development, anti-counterfeiting solutions, bottling and compliance, and adherence solutions.
The packaging services market can be divided into primary and secondary packaging. Primary packaging involves the initial filling of product into bottles, vials, etc. Secondary packaging involves more complex activities, such as blister carding and thermoforming, kitting and assembly, wrapping, bundling, tipping, clip stripping and other custom processes. While some of these activities can be performed using automated equipment, many of them require manual manipulations or exclusively employ semi-automated systems. Secondary packaging is, in fact, very challenging due to the large variability in materials, desired presentations and the intense need to reduce time to market despite the complexity of projects.
The most effective secondary contract packaging organizations, therefore, have built-in flexibility combined with excellent quality systems and highly skilled and creative designers, engineers and operators. They offer not only packaging services, but also comprehensive packaging solutions that encompass both packaging and process design. Collaborating closely with their pharmaceutical customers and working diligently to understand their specific needs, these contract packagers have the capability to provide non-traditional packaging solutions cost-effectively and in a timely manner.
Secondary packaging is the last step in the drug manufacturing process. For many secondary packaging tasks that involve aggregation or consolidation of multiple components, manual operations are not only necessary but provide a means for higher quality assurance. With appropriate training and process design, it is possible for manual operations to be more efficient and more accurate than automated methods.
In addition, manual process involves more than the use of hands to manipulate materials. Operators are visually observing the components and final products on a continual basis. There are many types of defects that are readily caught by human observation that are typically missed by automated visual inspection systems. This advantage provides added value, above and beyond the cost-effectiveness of well-designed processes.
Successful secondary packaging organizations have built flexibility into their operations. Cross training allows for the shifting of skilled workers from project to project where they are needed most. Thoughtful facility and process design also affords flexibility in meeting changing schedules and the ability to provide creative packaging solutions that are a challenge for traditional secondary packagers. Furthermore, an excellent balance of manual and semi-automated operations ensures that customer expectations for quality, delivery and productivity are consistently met.
CWS Packaging Services has been serving the pharmaceutical industry since the early 1990s with just this type of approach. With the assistance of integrated partner Proctor & Gamble, CWS developed and implemented an advanced quality system, achieved FDA registration, established cGMP capabilities and eventually developed ISO standardization. Today, CWS has the capabilities required to support the secondary packaging needs of pharmaceutical manufacturers large and small, capabilities that are complementary to those of primary packagers — particularly for challenging, multicomponent projects that require manual manipulations.
The company has been building its packing, kitting and assembly expertise since 1964 and offers complete solutions covering most secondary packaging processes (full kitting and final assembly, cartoning, overwrapping, tamper evidence applications, PIL affixing, blister carding, etc.), including package design, engineering and even in-house tool and die creation and machining. In addition to these services, CWS has provided notable success for its customers in managing rework and repackaging events; events such as FDA-mandated text changes affecting already completed finished goods. Recent investments include turnkey medical device manufacturing/packaging capabilities and a 250,000 cu. ft. controlled temperature warehouse for greater storage and distribution flexibility.
As a socially conscious not-for-profit 501(c)(3) organization, CWS offers further advantages not seen with other secondary contract packagers. Over 90 of the nearly 175 employees at CWS are uniquely enabled production resources with varying levels of physical or developmental disabilities. Extensive evaluation and training programs, coupled with internally developed ergonomic fixtures and production line enhancements, ensure that each employee (traditional or uniquely-abled) is placed in a position that matches his/her skill set and abilities, leading to consistent, extremely high-quality performance, which ultimately benefits the brand owners and the end-consumer experience.
Customers of CWS with social and corporate responsibility initiatives benefit from working with such a not-for-profit enterprise. There are also potential tax advantages. For instance, customers who transfer legacy product lines to CWS and donate the equipment realize not only reduced operating costs and operational optimization through the improved use of production floor space, but tax benefits as well. Thus, unlike the traditional business structure, the not-for-profit business model brings an extra dimension to the financial relationships that don’t exist with traditional, secondary packagers. Even though CWS performs manually intensive processes, the company is a cost competitive option based on having developed refined production processes and scalable, validated production lines to accommodate a wide variety of project scopes. The manually intensive approach to production also provides the additional benefit of visual inspection on the entire package at several stages, ensuring any defects, print deviations or otherwise, are gauged on every single unit processed. This added element of quality and value has assisted in preserving the brand’s intended consumer experience and has significantly constrained or eliminated any consumer complaints from the field.
Mr. Jason Lasicki leads the business development efforts for CWS Contract Packaging, operating out of the Norwich, NY, campus of facilities. He brings over 17 years of experience in developing innovative approaches to solving both complex and easily overlooked product challenges. Mr. Lasicki’s “start with the end in mind” approach to product enhancement and presentation optimization has successfully provided quantifiable value to the brand owners that he develops strategic relationships with on behalf of his company.