It’s no surprise that price competition is fierce these days. To profitably grow business and survive long term, contract manufacturers must bring more than low prices to the table. Adopting rapid microbial screening for faster product release is a cost-efficient way to reduce turnaround time. It also gives contract manufacturers a strong, competitive advantage to help them not only survive, but thrive.

Options for Faster Turnaround

There are two basic ways to shorten overall turnaround time: add capacity or increase efficiency. Adding capacity to decrease turnaround time can be accomplished by investing in high-speed production lines. Alternately, one can add capacity by adding a second or third shift; theoretically, you can get more produced in 24 hours with the same equipment.

But increased capacity doesn’t necessarily mean a CMO will be able to release products faster. And capacity is expensive.

If processes are laden with wait time that does not add value, the CMO’s best option is to look at ways to improve efficiency and become leaner. One must examine each step in production to see if there are goods or products waiting to move. Some symptoms of not being lean include:

• Producing more than customers order, “just in case”
• Stockpiling large amounts of inventory and safety stock
• Transporting materials to offsite storage or to holding areas instead of to distribution
• Contamination events that, although rare, lead to scrapping about a week’s worth of production.

So how does one get leaner and more efficient? In many manufacturing facilities, the limiting step for faster turnaround time is not the handoff from capping to shrink wrapping or cartoning. It’s the time it takes to get the results from microbiological testing.

By testing and releasing products faster, a CMO can shorten its production cycle, free up days’ worth of inventory and the warehouse space it consumes, and shorten the cash cycle. And it will also secure a competitive advantage over its competitors.

Traditional Testing Takes Time

With traditional testing for microbial contamination, a CMO is waiting three to seven days (or more) for test results on products that usually test negative for contamination. Meanwhile the Quality department is visually inspecting hundreds of Petri dishes and jars of product samples, one at a time over multiple days, monitoring them for signs of growth.

There is an alternative. Well-validated rapid methods are just as effective as traditional microbiological methods; more importantly, they’re faster. Rapid microbial detection offers definitive results, both positive and negative, in as few as 24 hours.

Adopting Rapid Methods

Rapid microbial methods (RMMs) are being implemented by increasing numbers of pharmaceutical companies, contract manufacturers, co-packers and contract labs to reduce turnaround time. Shortening the production cycle with faster product release screening can unlock huge operational savings. Instead of holding materials or products for several days while awaiting microbiological test results, rapid methods can provide assurance in as few as 24 hours. This translates into an average five-year net present value (NPV) savings of $500,000 or more for a facility.

For a contract partner, the benefits of more efficient manufacturing and quality processes also apply. Taking less time to complete a customer order means the CMO is invoicing faster and getting paid faster, shortening the cash cycle. Since the CMO won’t need as much space to house product in micro hold, extra warehouse space will be freed up, increasing capacity for additional business. Plus, the CMO gains a competitive advantage by helping customers be more responsive to their changing market needs.

Improved efficiency also reduces recovery time in the event of a contamination. At these times, when so much is at risk, the benefits of rapid methods are doubled. The faster that corrective action starts, the faster all parties recover, reducing the potential impact on customer relationships and the bottom line.

Who Benefits from Rapid Screening?

Almost any company can use rapid methods, but each system will determine one’s ability to benefit from it. For example, a CMO will need a system with the testing capacity to keep up with full-scale operations. It’s not “rapid” if it creates a bottleneck in the operation. Similarly, if the method only works on one type of material, such as water, it will be less useful than a more flexible system capable of also testing viscous and heavily pigmented samples.

Equally important, the right rapid system should be focused on providing the information needed to ship the majority of your products to market safely. In other words, how quickly will the system confirm the absence of contamination—your most likely product state?

The pharmaceutical industry is an ideal place for rapid screening. Manufacturing and packaging of pharmaceuticals are done under conditions today that produce products to spec 99% or more of the time. Yet traditional micro screening typically takes three to seven days for limits testing and 14 days or more for sterility. That’s a long time to wait when you have a quality manufacturing process in place that is turning out products free from bioburden almost all the time.

When a positive result is rarely expected, and there is rarely anything to count or enumerate, the wait time for product release becomes frustrating and expensive.

Regulatory Support for Rapid Methods

Transitioning pharmaceuticals and other regulated products to a rapid release method is becoming more straightforward and is, in fact, supported by many global regulatory bodies, including the U.S. FDA.

The preferred approach is, “Tell them what you’re going to do, do it, and then tell them that you’ve done it.” Albeit highly simplified, this is a reasonably accurate description of the FDA’s Comparability Protocol.

The centerpiece, or “do it” part, is validating the product or group of products for routine release using the rapid method. This includes side-by-side testing to ensure the rapid method is equal to or better than the traditional method. During this stage, lab staff members become more practiced and confident in the rapid system so that once the validation data is collected, the RMM is effectively implemented.

A rapid system provider may have regulatory compliance expertise that the CMO can tap into, as well as drug master files (DMFs) accepted by the FDA. The DMFs include data for specificity, limit of detection, robustness, ruggedness and equivalence, and can be used to supplement or streamline the validation of a rapid system. This may save significant time both in preparation and in the FDA’s review and approval process.

CMOs should ask their system providers about regulatory compliance assistance and additional resources such as white papers and validation guides.

The Economics of Rapid Methods

Rapid methods are not about costs; they are about saving money and creating a competitive advantage. While there is often an increased cost for reagents, the operational and, hence, financial benefits far outweigh the expense.

• If a CMO stores batches or products awaiting test results, it will benefit by reducing working capital investment in inventory.
• By reducing investment in inventory, the CMO will benefit by clearing out space in the warehouse.
• If the CMO carries safety stock, it will further benefit from cutting it down to size.
• If the CMO manages a brand, it will benefit from the faster response time it can offer distributors and from reducing the risk of contaminated product reaching consumers.
• If the CMO competes against other CMOs, offering faster turnaround time will win more business.

The Opportunity of Rapid Methods

Controlling costs and operating more efficiently are priorities for everyone in the pharmaceutical value chain. Contract manufacturers can reap these benefits and create a sustainable, competitive advantage by offering their customers faster turnaround times thanks to rapid microbial screening.  

Cindy Lieberman is vice president, Celsis International Ltd. She can be reached at 312-476-1260 or clieberman@celsis.com.