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Third-party contract packaging service providers can help save time and money.
Pharmaceutical manufacturers strive to address many concerns including cost and lead times in the supply chain. “Speed to market remains a top priority with our clients,” says Kristin Smith, client coordinator at Sharp. Other concerns include compliance with stringent quality control requirements and delivering on sustainability commitments.
Outsourcing operations, especially packaging, addresses these priorities and generates many benefits for pharmaceutical manufacturers. As a result, 60% of pharma manufacturers outsource at least a portion of their operations to a third-party contractor, according to 2022 Pharmaceutical Manufacturing: Trends Shaping the Future, a report published in March 2022 by PMMI Business Intelligence, a division of PMMI, The Association for Packaging and Processing Technologies. Driving forces behind the interest in outsourcing include the rise of injectables and personalized medicine and the accelerated pace of new product development, which has strained production capabilities for pharmaceutical manufacturers (1).
Packaging is often outsourced because of its complexity. Smith at Sharp explains, “Packaging involves a degree of technical, operational/process, and design complexity, which creates the need for ‘solutions’ providers … to manage packaging as a holistic process including design, engineering, packing, serialization and aggregation, foreign-trade zone, qualified person services and release, stability, and ID testing.” In addition, outsourcing can provide “a partner who can offer a breadth of regulatory and rapid launch requirements, including global regulatory requirements for multi-market launches.”
Contract packaging services provide numerous advantages for both clinical trials and commercial medicines. Contract packagers “can offer expertise, flexibility, and efficiency, while further mitigating risk and maintaining product quality and safety,” says Justin Schroeder, global vice-president of technical sales at PCI Pharma Services.
For example, “using a contract development and manufacturing organization (CDMO) allows companies to benefit from the expertise and specialized knowledge gained through handling a wide variety of products with varying parameters, such as ultra-low temperature handling,” says Harry Lindenmuth, vice-president operations at Almac Pharma Services, who oversees the company’s Audubon, Pennsylvania, site.
Smith at Sharp agrees, noting third parties often are chosen for therapies that require more complex handling, assembly, packaging, and storage requirements (e.g., cold chain, frozen storage, or high-value small-batch drugs). In addition, contract packaging organizations maintain a broad network of suppliers, including those who will collaborate on sustainable packaging efforts.
Reduced costs are a major benefit of outsourcing because manufacturers don’t need to purchase, install, and validate new equipment and lines, thereby freeing up capital and personnel for use elsewhere in the operation (1). Eliminating the need to invest in packaging equipment, labor, materials, and floorspace allows pharma and biotech companies to focus on their core competencies (drug development and manufacturing). This not only lowers costs but “also provides greater flexibility and scalability, enabling them to grow quickly and adapt easily to changes in demand,” says Lindenmuth. The outcome is improved supply chain efficiency and inventory management and reduced lead times.
Josh Goolcharan, director of sales and marketing at Reed-Lane, agrees, noting, not only are packaging activities outsourced but these partners are asked to manage the procurement of all necessary components. He says, “This allows customers to focus efforts more on marketing existing products and developing additional ones.”
Speed to market may be the biggest benefit of outsourcing pharmaceutical packaging. Outsourcing can deliver rapid launch support and/or launches in multiple markets across the globe and reduce risks by providing a deep understanding of up-to-date regulatory and compliance guidelines in multiple countries.
Outsourcing also can strengthen the supply chain and provide production redundancy. “Single sourcing is no longer a viable strategy when material and labor shortages persist in many countries,” explains Schroeder. He adds, “PCI and other CDMOs are organized and structured with flexible assets complemented by a network of locations around the globe to move quickly and operate with agility. [Service providers can also] increase speed by serving in a consultative advisory capacity, helping clients streamline their approach and avoid unnecessary steps.”
Engaging an experienced CDMO expands packaging options and enhances quality and efficiency because it provides access to knowledgeable teams, who routinely handle various types of pharmaceutical packaging. “Companies are provided with the surety that their packaging is performed correctly and consistently, and that processes, such as serialization, are performed to the highest level of compliance,” says Lindenmuth.
In short, “the right contract packaging organization can offer the experience, expertise, and technology to handle various packaging complexities,” says Smith. Wide-ranging expertise includes:
Whatever services are provided, the manufacturer and CDMO must forge a collaborative relationship. Fully understanding the product, patients, and target markets ensures all criteria are met and the product reaches the patient on time and in the optimal format.
To meet rising demand, service providers are expanding their capabilities. For example, PCI Pharma Services has added new facilities in Bedford, New Hampshire; Bridgewater, Massachusetts; and Rockford, Illinois; to serve customers in key geographies. These expanded capabilities, which include innovative packaging and manufacturing methods, have been implemented in recognition of the need to get treatments to patients quicker than before, emphasizes Schroeder.
The company also has invested in software and expanded service offerings. Its pci | bridge digital supply chain management platform provides customers with a direct look into their systems and network of locations. “This digital supply chain management platform … gives clients access to real-time updates and information like production and order management status, inventory, batch release, global distribution, and invoicing,” says Schroeder.
PCI’s new consultative offering, SpeedSolutions, complements core manufacturing, clinical trial, and commercial packaging services. “SpeedSolutions allows PCI to shape and guide successful outcomes … by accelerating client molecules across the various phases of drug formulation and process development, analytical development, clinical trials, and ultimately, global commercial supplies,” reports Schroeder.
From its European Centre of Excellence, Almac Pharma Services offers specialized ultra-low temperature packaging that enables advanced, lifesaving medication to be packaged, labeled, and distributed in temperatures between -20 ºC and -80 ºC. “Our team works closely with clients to define … a tailored, robust, and commercially scalable process which takes into consideration the temperature requirements, allowable time out-of-condition, conditioning time requirements, final pack-out configuration, level of serialization aggregation required, temperature-controlled distribution, and global supply chain needs,” says Lindenmuth. With this capability, the CDMO has “processed and QP [qualified person]-released over 1000 batches, enabling them to be transported direct to the patient within as little as 20 hours.”
Almac Pharma Services also has invested in stick pack and sachet capabilities across all of its facilities. Installation of a triple-head dosing module has boosted capacity. “This key investment was in response to the increased demand from our clients in commercial packaging for pediatric formulations such as powders, granules, and mini-tablets,” reports Lindenmuth. Specialized packaging such as stick packs and sachets enables accurate dosing of drug products by offering pre-measured amounts, reducing over- or underdosing, and providing increased portability and convenience for patients. Sachets also can be customized with printed instructions and branding.
At Sharp, investments are focused on secondary packaging services for injectables and gene therapy. For gene therapy products, which typically involve small volumes and requirements for time- and temperature-sensitive handling, a dedicated 1000 ft2 packaging suite at its facility in Bethlehem, Pennsylvania, includes dedicated high-efficiency particulate air-filtering systems with full redundancy and an emergency power generator. Two ante-rooms at entry maintain positive pressure to ensure the cleanliness of the suite. An automated system constantly monitors temperature, humidity, and dew points and sends emergency alerts if a deviation occurs. Dedicated -80 ºC freezers also are monitored 24/7 (2).
Although Sharp specializes in secondary packaging for injectable formats, it also can provide isolator-based sterile filling and lyophilization services via its 25% stake in Berkshire Sterile Manufacturing. Semi-automated and automated, isolator-based filling lines offer the flexibility to handle syringes, cartridges, vials (either ready-to-use or bulk), and lyophilized products. On the fully automated line, robotics and multiple vision systems minimize the need for intervention by human operators (3).
Goolcharan concludes, as packaging experts, contract packagers offer cost-effective processes, the flexibility to address low- and high-volume requirements, and familiarity with multiple packaging styles (e.g., vials, pouching, bottles, blisters, carding, secondary operations, and kitting).
Hallie Forcinio is packaging editor for Pharmaceutical Technology.
Vol. 36, No. 6
When referring to this article, please cite it as Forcinio, H. Generating Benefits with Outsourced Packaging. BioPharm International 2023 36 (6).