Finding The Balance Between Cost And Innovation: Equipping A Flexible Facility With The Right Partner
By Justin Kadis
As the pharmaceutical industry has diversified, there has been a shift in the way facilities are structured. The industry has begun to lean toward wider adoption of multi-product or flexible facilities in an effort to maximize production and prove to customers that any request can be fulfilled by a singular company that is not bound to traditional methods of production.
Many pharmaceutical companies are looking to concentrate their outsourcing to one or a few contract firms that can handle the bulk of their production needs. If a contract developing and manufacturing organization (CDMO) is able to front-load the majority of their drug development and production, the pharmaceutical company sponsor eliminates major risks in the supply chain that can result from employing too many partners at all phases.
Instead, sponsor organizations are seeking long-term partnerships with a single CDMO when possible, and then developing and growing in conjunction with their supplier. This is ideal for the development organization that wins the contract — increased business translates to internal improvements, which will grow the business even more. As such, symbiotic partnerships between sponsors and supplier organizations are increasingly sought throughout the drug development chain.
Thus, CDMOs that can successfully demonstrate their aptitude for flexibility in production have much to gain — especially in the current, ever-evolving pharma landscape. In order to prepare a facility and be able to rise to the challenge of the trend of flexible and multi-product facilities, one must have a full understanding of what it means to operate under these paradigms, including the difference between each type of facility and the integral role of equipment in any type of facility. Here, we highlight the trend of multi-product and flexible facilities, defining the different types of facilities and how working with a partner such as Federal Equipment Company is a strategic move for any company looking to achieve an internal update in the most cost-efficient manner possible.
Understanding and Differentiating Flexible Facilities
Having a designated equipment line for a single dedicated product has become an outdated practice. Companies that want to grow must be able to develop more –– and often different types of –– drug products and drug substances.1 Flexibility is achievable on many levels in a facility, which is part of what makes it so complex. Firstly, process flexibility must be taken into account. This includes the production mode and mix, as well as scale and volumes. Following this is suite-level flexibility, which is defined by how the suite is configured in the larger framework of the facility. This funnels into operational flexibility, or how the organization operates as a whole. Site and integration flexibility is yet another level, as is investment flexibility — the board of an organization is constantly working to meet flexibility on all fronts without crippling the company’s bottom line and going over budget, especially without a known payoff.1
Flexibility and Autonomy: Factoring Independence Into a Facility
In a flexible facility, multiple products are produced, and there is an ease of scalability.2 The facility and the operations contained within are designed to adapt to capacity needs, with particular processes ramping up, or down, as demand dictates. The most flexible facilities are engineered such that individual components can be autonomous, including cleanrooms and equipment shared among processes.
As Maik W. Jornitz, President and CEO of G-CON Manufacturing, Inc., a manufacturer of cleanroom pods writes, this is a key feature of the flexible definition. “True flexibility comes with autonomy of the critical cleanroom space; as such autonomous, compact cleanroom systems can be painlessly decontaminated and sanitized, controlled and re-used. The cleaning and repurposing of autonomous cleanroom spaces make them ideal for multi-product processing, Furthermore, these systems can be deployed fast track and, if needed, moved.”2
This hedges on the concept of “mini-sites,” which resemble autonomous pods and are constructed off-site for use where they are needed. These pods can take any dimension and are modified for the project design needed.
Facility Classification: From Traditional to Pod
Facilities fall under one of the following categories: brick and mortar, modular container, stick-built modular, isolator or controlled environment module and autonomous pod.2
Brick and mortar facilities are often built in a segmented fashion dedicated to specific products. As designated areas of the facility are dedicated to the life cycle of a single product, the ability to repurpose the facility may be limited.2
Modular containers have container systems built off-site that are connected at the final location to form a complete facility. These facilities can often be difficult to scale.2
Stick-built modular facilities feature modular wall panels. The facility is finished with these panels and is designed to accommodate windows or pass-through doors.2
Isolated or controlled environmental modules are built off-site and are mostly used in a cleanroom area because of the way it can be sanitized. They are repurposable and easily decontaminated.2
Autonomous pods are built off-site and function as a stand-alone cleanroom module that is available in various sizes. These pods can be custom fitted for a project and offer an ease of decontamination.2
Procuring Equipment for any Facility within Budget
For each type of facility, there is a need to procure equipment. The trend of the flexible facility has carried over to the trend of flexible equipment. Having a rigid brick and mortar plant with immobile equipment ––the traditional way to model a plant –– is no longer considered the best practice, based on the multitude of changes in the industry, coupled with the internal push towards improving processes and innovation on all fronts.
In a roundtable with the American Pharmaceutical Review, a panel of experts was asked to comment on the trend of flexible and multi-product facilities.3 They were further queried about the future of equipment when considering this bigger picture. The general consensus was that innovation on the equipment front is expected to match the facility trend.
“The adoption of flexible and portable equipment will continue to grow so that companies can acquire assets that can be used as broadly as possible to meet their needs,” noted Katherine A. Bakeev, Director of Application Support Services for B&W Tek, Inc. “As instrumentation miniaturization develops further, the advantages this brings in the ability to measure starting materials and products more easily, more frequently and with less movement of materials will result in higher assurance of product quality. This flexibility and increased testing ability will help to identify potential issues earlier, thus resulting in higher product quality reaching final customers,” she told the publication.3
Surendra Balekai, Product Manager for Thermo Fisher Scientific, highlighted the expense associated with both traditional facilities and equipment, which has placed an unnecessary burden on pharma. “As of today, [the] industry is under pressure to build facilities for multi-products and have flexibility for capacities. Moving forward this will be standard. Molecules in the clinical phase need a couple of batches processed. Flexible equipment/facilities are the most economical way to build, manage and sustain. Millions of dollars are spent in maintenance of traditional facilities, [the] industry can’t afford to and doesn't want to continue down this path.”3
About Federal Equipment Company: A Strategy of Partnership: Relying on a Used Equipment Expert
When procuring equipment for a flexible facility, it is essential to work alongside a partner that understands your specific goals. It is critical to select the best and most appropriate equipment to meet your production objectives and to ensure it fits within the facility’s current processes and as it scales.
A strategic partnership with an equipment supplier like Federal Equipment Company –– with experience with a range of original equipment manufacturers and with clients in setting up multi-product and flexible facilities –– is a crucial asset for any company looking to diversify their operations. Federal Equipment Company offers competitive prices on thousands of pieces of used pharmaceutical processing equipment from top equipment manufacturers. Additionally, we offer critical value-added services, including operator training and troubleshooting for solid dose equipment and a validated three-step equipment bio-decontamination process.
Innovation requires investment, but any major change in operations requires a balance to ensure that the cost burden of the change does not offset the potential benefits. To achieve the desired outcome without going over budget, an organization should consider used equipment from a reliable partner when possible.
References:
- Thomas, Aeby, and Morten Munk. “Meeting the Demand for a New Generation of Flexible and Agile Manufacturing Facilities: An Engineering Challenge.” BioProcess International. 18 Dec. 2015. Web.
- Jornitz, Maik W. “Defining Flexible Facilities: When is a flexible facility being flexible?” Pharmaceutical Processing. 19 Apr. 2013. Web.
- “Flexible Facilities Roundtable.” American Pharmaceutical Review. 31 May 2015. Web.