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How Labs Large or Small Benefit from Custom Manufacturing

Finding the right custom/OEM manufacturing partnership accelerates research, testing, and time to market

Promega Corporation

Labs within disciplines like biotech, applied and environmental sciences, and clinical testing frequently need custom solutions for specific applications, from adapting fill volumes and packaging to maximizing workflow efficiencies or developing custom formulations or kits. Finding a custom manufacturing partner offers major advantages over developing solutions in-house, which can be extremely time- and resource-consuming to build. To effectively support labs, however, a custom/OEM manufacturer must have the expertise, facilities, resources, and a quality system to deliver quality products every time, for every application.

Expertise in custom formulations

Applications in applied markets cover wide-ranging environments, sample types, and tests with highly specific needs that frequently benefit from custom solutions. Whether detecting microbial contaminants in water, isolating DNA from food or plant samples, or monitoring viruses in wastewater, the research conducted in applied testing has serious implications for real-world settings. Applied testing labs need consistent, quality testing solutions to help them make better informed decisions more quickly. Partnering with the right custom manufacturer provides the experience and expertise necessary to find functional solutions the first time.

Two demonstrative examples of the potential gains in testing environments include environmental and industrial water testing and plant and food testing.

Bioluminescence as an early warning system

Bioluminescence-based technologies allow rapid testing of water samples for bacteria and other microbes that can cause a host of problems, including biofilm formation (membrane fouling) and microbially induced or influenced corrosion. These detection systems provide consistent, low-level detection of all live microbes in minutes, making them an excellent early warning system for environmental and industrial water monitoring compared to traditional culture-based tests that require days.

Luciferase, the enzyme responsible for luminescence in fireflies, catalyzes a reaction with ATP from live cells to release light. Two examples of luciferase enzyme testing kits, the Water-Glo™ System and the BacTiter- Glo™ Microbial Cell Viability Assay, offer marked advantages including high sensitivity with a lower detection limit of 10 cells, resistance to test compound interference, automation capability, and compatibility for multiplexing with other assay technologies.

There are a number of water-testing applications that involve monitoring microbial levels in order to help protect public health and infrastructure integrity, such as testing industrial process water, drinking or public utility water, wastewater, desalination, and cooling towers. By partnering with a custom manufacturer, these specialized applications can benefit from having kits customized specifically to address their testing requirements and unique workflow needs. The Water-Glo™ System, for example, can be customized in a number of ways, including producing substrates, reagents, and buffers in bulk, in specific concentrations, and in specialized formats.

Molecular testing for food and plant industries

Molecular methodologies like qPCR are the fastest, most reliable tools for assessing a variety of issues in plant and food testing, including pathogen detection, disease resistance, transgenic seed development, yield improvement, population genetics, or plant physiology research. Optimizing reactions is key to achieving consistently high performance specific to a given application or assay. The ability to order fully customized master mix compositions of buffer, dNTPs, enzymes, and magnesium can have a large impact on testing quality, speed, and efficiency. In addition to custom kit options, Promega facilitates the optimization process with support services or a PCR Optimization Kit for users who want to quickly determine optimal conditions and concentrations on their own. Additional customization options include product format, packaging and labeling, and dispensing size.

Worker oversees operation of an automated liquid handling platform
Credit: Promega

Custom manufacturing partners must have a deep knowledge base and expertise to support a lab’s success and to provide accurate, scalable solutions for plant genomic analysis, food identity and contamination testing, water quality testing, epidemiological surveillance, and toxicology testing. The Promega applied and environmental sciences portfolio is built on key technologies, including nucleic acid extraction, PCR amplification, and bioluminescence detection. With Promega custom manufacturing, cross-functional teams of knowledgeable scientists can adapt these existing products and technologies to meet specific customer needs, whether that's customizing a single kit component or an entire assay. These teams work collaboratively with their customers, enabling them to develop and deliver solutions that are tailored to the specific needs of the customer's workflow and application.

The importance of quality systems

Virtually all labs require a consistent, reliable, and reproducible source of high-quality products for their workflows. Finding a manufacturing partner with a quality system in place can save any lab the extraordinary expenditures required to establish their own quality manufacturing facilities. It is particularly beneficial for clinical and molecular diagnostic laboratories to partner with a manufacturer with an established quality system, as it ensures consistent production that meets the rigorous standards of cGMP regulations and ISO certifications.

Quality in clinical and molecular diagnostic labs

Clinical and molecular diagnostic labs, which rely on high-quality general-purpose reagents, face several specific challenges around efficiency and reliability requirements in addition to staffing and workload constraints.

Patient samples are precious and volume-limited. Repeating an assay, when possible, costs the physician, patient, and lab time as well as monetary costs. Testing labs must have full confidence in the materials they use.

Similarly, clinical labs require tools that are reliable, easy to use, and efficient. Diagnostic testing supports disease diagnoses, treatment, management, and prevention, informing healthcare decisions and treatment plans by physicians and other medical professionals. Labs need to process high volumes of samples quickly without sacrificing quality or accuracy.

Efficiencies in sample processing are particularly important in the face of staffing and workload challenges recently exacerbated by the pandemic years. Labs are frequently understaffed and faced with an overwhelming number of samples to process.

A custom/OEM manufacturing partnership can help address these challenges by adapting catalog products and existing technologies to create tools that specifically fit the customer’s needs—from custom master mixes that can help tackle bigger blocks of testing at a time to helping labs plan and implement automation into their workflow.

Partnering with a custom/OEM supplier that has an established, well-implemented quality system provides additional benefits. A partnership can improve predictability of product manufacture, ensure consistent product performance through documented processes and procedures performed by qualified, trained personnel, and facilitate any necessary product investigation in the event of non-conformance using established systems. By utilizing their manufacturing partner's mature quality system, labs can save time and money by not having to build their own controls.

Equipment in a fermentation lab
Credit: Promega

To form an effective partnership, custom suppliers must have the ability to adapt products to meet a lab’s specific needs. Promega manufactures product under a ISO 9001 and 13485 quality system. Their cross-functional teams have worked collaboratively to adapt existing catalog products to accommodate the manufacturing needs of diagnostic lab products in addition to resolving the pain points described above.

Logistics and infrastructure support mitigate supply chain problems

Global logistics operation and distribution networks can ensure timely delivery and facilitate importation, storage, distribution, and exportation. The value of operations with built-in redundancies is emphasized by recent supply chain issues. Delays can create bottlenecks, slow research, and lead to lost costs for the company or lab.

Packaging design and fill volumes can have a substantial impact on lab efficiencies. The complexities of package design are frequently underestimated. Changes may take packaging engineers time to design appropriate primary, secondary, and shipping containers that ensure product safety and stability throughout transport and storage, a process that frequently involves in-house testing with specialized equipment. Labs with specific packaging needs will need a partner that can deliver.

In one example, highlighting the benefit of custom packaging, Promega worked with a major research institution that required a large volume of CellTiter- Glo® Cell Viability Assay reagents. These reagents are traditionally shipped in individual glass vials wrapped in bubble wrap, which can be tedious and time-consuming to unpack for extremely large quantities. The Promega field applications specialist for the account worked with the custom operations team on a solution that would reduce packaging materials while ensuring safe delivery. The team designed a new packaging configuration that met stringent quality and packaging requirements and protected the product from damage, allowing the customer to unpack the entire shipment in under an hour.

Packing custom kits - A disembodied hand places a reagent vial into a kit box within an open flat of kits during assembly
Credit: Promega

In high-throughput applications, like drug discovery screening, efficiency and timeliness of results is critical. Additional customizations offered by Promega that can maximize lab workflow efficiencies include customized reagent volumes from 0.5 mL to 650 L, custom substrate options provided by in-house state-of-the-art lyophilizers, and bulk packaging components to streamline packaging.

Finding the right partner for custom solutions can make the difference in quality assurance, enhanced productivity, and preventing delays across fields and applications. Leveraging a partner’s experience can accelerate testing results, time to market, and answers to research questions. Promega is a partner that offers the service, expertise, quality, and infrastructure required to deliver quality products consistently, save labs time and money, and help advance their research.

To learn more, visit promega.com/CustomStory

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Credit: Promega