Growing Use of Lateral Flow Tests Within the Pharmaceutical Manufacturing Industry

Growing Interest From Pharma
Quality Control of Raw Materials
In-Process Controls
Beyond Quality Controls
Advantages of Lateral Flow Testing
Key Takeaways

In this blog Abingdon’s CEO, Chris Yates, considers the significant growth in the use of lateral flow tests within the pharmaceutical manufacturing industry, as a way to improve efficiency and save on cost.  

Abingdon Health’s team has over 15 years’ experience in the lateral flow market and is a knowledge leader in the design, development, scale-up, transfer, manufacturing and regulatory approval of lateral flow test development across a range of sectors.  

Growing Interest from Pharma

Lateral flow tests (LFTs) have gained prominence in pharmaceutical manufacturing for their rapid, diverse and cost-effective applications. These diagnostic devices, also known as immunoassays, can play a crucial role in ensuring product quality, safety, and efficiency. LFTs can also be used across a vast array of applications, with highly accurate results; hence, the appeal to pharmaceutical manufacturers.

Quality Control of Raw Materials

In the pharmaceutical industry, where precision and speed are paramount, lateral flow tests offer a valuable solution. These LFTs operate on the principle of capillary action, allowing for the quick and easy detection of specific analytes. One of the primary applications is in the quality control of raw materials used in drug production.

Pharmaceutical manufacturers rely on lateral flow tests to verify the authenticity and purity of incoming materials. By swiftly identifying any contaminants or impurities, these tests contribute to maintaining the integrity of the entire manufacturing process. This not only ensures the safety of the end product, but also prevents costly production errors.

In-Process Controls

Moreover, lateral flow tests find extensive use in the monitoring of critical manufacturing steps. During the production of pharmaceuticals, various checkpoints must be rigorously assessed to guarantee the desired quality. Lateral flow tests enable real-time monitoring, allowing manufacturers to make prompt adjustments if deviations occur, thereby reducing the likelihood of producing substandard batches. Compared to the use of laboratory methods, LFTs can offer the benefits of speed and cost-effectiveness, to reduce delays in production and ensure that manufacturing efficiency is maximised.

Beyond Quality Control

The versatility of lateral flow tests extends beyond quality control. For example, they are instrumental in the validation of cleaning procedures for manufacturing equipment. By quickly detecting residual traces of active pharmaceutical ingredients or cleaning agents, these tests aid in preventing cross-contamination between different production runs.

LFTs can also be used to confirm the presence of active ingredients in production, and this is particularly valuable where such ingredients are in short supply or are extremely expensive; getting a batch wrong can not only lead to financial losses, but also regulatory scrutiny.

Another notable application is in the detection of microbial contamination. Lateral flow tests equipped with specific antibodies can identify the presence of harmful microorganisms. This is particularly crucial in pharmaceutical manufacturing, where maintaining a sterile environment is imperative to ensure the safety of the final product.

One of Abingdon’s manufacturing customers Protak Scientific, is actively involved in this market. Their Enzyme Indicators product is a unique, advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance. This has the potential to transform the validation process in pharmaceutical manufacturing and other applications including healthcare and research; offering a fast, cost-effective, accurate and safe alternative to conventional methods.

Advantages Of Lateral Flow Testing

The adoption of lateral flow tests in pharmaceutical manufacturing is driven by the need for rapid and accurate diagnostic results. Traditional analytical methods often require time-consuming sample preparation and complex instrumentation. In contrast, lateral flow tests provide results within minutes, allowing for swift decision-making in a fast-paced production environment where quality and precision is key.

Cost-effectiveness is also a significant advantage of lateral flow tests. Traditional analytical techniques can be resource-intensive, requiring expensive equipment and skilled personnel. Lateral flow tests, with their simplicity and minimal infrastructure requirements, offer a more economical solution without compromising accuracy.

As pharmaceutical manufacturing continues to evolve, regulatory authorities are increasingly recognising the reliability of lateral flow tests. Many regulatory bodies now accept data generated from these tests, provided they meet specific validation criteria. This acknowledgment further solidifies the position of lateral flow tests as a valuable tool in ensuring compliance with stringent quality standards.

Key Takeaways

In summary, integration of lateral flow tests into the pharmaceutical manufacturing process is bringing about transformative benefits. From rapid and cost-effective quality control, to real-time monitoring of critical steps to ensure manufacturing environments are contaminant free, these tests have become indispensable in maintaining the exacting standards required by the pharmaceutical industry. As technology advances and regulatory acceptance grows, lateral flow tests will play a more pivotal role in shaping the future of pharmaceutical manufacturing.

Decades of experience in taking tests from concept to commercialisation has led to Abingdon Health establishing effective processes that ensure efficient and cost-effective development, technical transfer and scale-up of the rapid diagnostic products we develop for our customers. Abingdon adheres to Good Manufacturing Practices (GMP) to ensure tests are manufactured in a consistent and robust manner, batch in and batch out. Contact our team to see how we can help take your test from R&D into reliable manufacture and commercial success. Also, discuss our value-added services such as regulatory and commercial support that provides a de-risked and streamlined route to market.