The Covid-19 pandemic is teaching us that preparing for unexpected events should not be underestimated. Being ready for the unforeseeable in 2021 and beyond requires both the monitoring and creation of market trends as well as contingency planning. This involves ensuring high product quality, building agile supply chains, and working with experienced and reliable partners. We take an insider’s look at the checks and balances that diagnostics manufacturing companies need to implement to make their businesses disaster-proof.
The ongoing public health crisis has served to hasten the adoption of technology as industries worldwide keep pace with pandemic imposed restrictions. Seemingly overnight, diagnostic testing has moved from being a medical setting requirement to becoming a crucial part of daily life, with our new normal mandating medical swabs prior to traveling.
While the pandemic is responsible for an attitude shift towards technology readiness resulting in amplified market trends that would have otherwise taken years, it has also brought on a renewed appreciation for contingency planning.
Having an emergency plan enables companies to revert to their daily operations soon after an unforeseen event occurs. Without them, a company runs the risk of losing critical resources, creating bottlenecks in production and supply, inconveniencing its customers, and potentially jeopardizing its business.
Despite this, the diagnostics sector, less regulated than the biopharma sector, has long regarded contingency planning as a mere formality. But far-sighted biotech companies have always stringently undertaken preventative measures to protect from the unforeseen.
“Contingency planning has never been a matter of choice for biomedical players as it is a part of our responsibility. It is expected by customers, especially those from industrial business-to-business collaborations. Moreover, it is also a social mission to have measures in place to secure the quality and continuous availability of our products,” elaborated Tomasz Wrzesinski, Vice President at BLIRT, a molecular biology enzymes manufacturing company.
The importance of validating quality
Over the last two decades, as quality management systems have advanced, contingency planning has taken the form of quality agreements in contracts within the life sciences field. Even in the absence of such contracts, ensuring that standards are met for International Organization for Standardization (ISO) and Good Manufacturing Practice (GMP) certifications, and preparing feasible business continuity plans, are core liabilities undertaken by the manufacturers.
ISO certifications provide an external seal of approval showing that all systems, processes, and services within a company meet the industry standards. In parallel, GMP regulations certify that a company’s production and quality systems are highly controlled, resulting in safe and reproducible end-products.
Both of these stringent certifications work together to help minimize risks such as safety hazards, product contamination, incorrect labelling, and inconsistent products.
“Working under ISO and GMP certifications means being answerable in regular external audits and validating processes through the product life cycle,” explained Wrzesinski. “It starts with conducting risk assessments. When one measures a high probability of significant risks, a written business continuity plan is formulated.”
Contingency planning: ensuring undisrupted supply
Supply chain disruptions during the ongoing Covid-19 pandemic have been a major test to the durability of business continuity plans drafted in the biomanufacturing sector. As global borders closed to curtail the spread of the virus and protect local stocks of pandemic-related materials, imports from the US and China into the EU and vice-versa were suddenly interrupted.
During the peak of the pandemic, many medical products were in short supply: from simple personal protective equipment, such as latex gloves, to more complex products, including medications and dialysis materials. This resulted in the rationing of products and delays in care, disrupting the delivery of essential healthcare products worldwide.
For life sciences businesses, such shortages reaffirmed the importance of diversifying suppliers as a part of contingency planning.
“Qualifying more than one supplier is a must in risk assessment. If the component sits within your process, but your supplier is unable to provide you with the product on time, your entire process is at risk,” cautioned Wrzesinski.
An eye for scale and quality
In fact, suppliers especially appreciate and acknowledge the importance of quality assurance and risk management. For example, as a global raw material and enzyme supplier for biomanufacturing processes, BLIRT assures its customers of quality products by regularly undertaking inspections and validations as part of its ISO certifications.
The BLIRT team is also in the midst of implementing processes and preparing for a further medical device ISO certification as a matter of priority this year.
Furthermore, to ensure that the supply of recombinant enzymes meets its customers’ demands, BLIRT plans production volumes and stocks its upstream reagents well in advance. Over the last year alone, the team has successfully delivered a six-fold increase in production by upscaling its enzymes manufacturing and opening an additional production location to meet customer demand.
“At BLIRT, we dedicate a lot of effort to ensure that our production runs in spite of any problems that our own suppliers may face,” said Wrzesinski. “We conduct our operations out of three independent sites and are divided into four sub-teams. In case of any emergency, this safeguards our processes as well as our production and allows our supply to continue uninterrupted.”
Aligning priorities
Another factor that has helped BLIRT overcome challenges, such as those caused by the pandemic, is the unique flexible cooperation model that it operates on. This model allows customization of services and product characteristics based on client needs and is central to BLIRT’s motto “Enzymes – as You need”.
“We know our customers and often develop products and product variations together with them. Our high involvement and small company size enable us to be flexible in our approach for every customer,” said Wrzesinski.
Prompt and open communication is a natural by-product of BLIRT’s operating model. During the pandemic, by exercising transparency and leveraging on-ground contacts, BLIRT kept product prices consistent for its long-time partners, despite significant growth in costs of raw materials and labor.
Being innovative and prioritizing longstanding partnerships has helped manage unpredictable business situations to a large extent, explained Wrzesinski.
Planning for future innovations
Developing products with its customers also gives BLIRT a unique opportunity to not just monitor but also be a part of creating future market trends. This has been instrumental in predicting and preparing for sudden market changes, such as the increased use of PCR tests and the development of new solutions like reverse transcription loop-mediated isothermal amplification in RNA diagnostics due to Covid-19, elaborated Wrzesinski.
“For biotechnology products, even simple scale-up takes months, but it helps when we can pick up market signals to know what will drive mainstream demand,” he continued. “We have managed to do our homework and react relatively fast to the increased demand for proteinase K, RNAase inhibitors, and RNA extraction kits.”
BLIRT’s cross-functional teams work alongside customers to resolve issues: from kick-starting the collaboration to designing and qualifying processes, all the way until producing and scaling up the product. Therefore, hiring and retaining the right expertise has also been crucial in contingency planning, for tackling unplanned events.
“We recently crossed the quarter-century mark as a molecular biology company in the market,” said Wrzesinski. “This would have been impossible without our teams’ in-depth competencies on different applications of our enzymes. Our success is a testament to the talent that we are fortunate to retain within the company.”
Conducting stringent quality checks, anticipating production challenges, monitoring, and reacting promptly to trends, as well as engaging the right workforce are all key to 21st-century contingency planning. Ultimately, it boils down to working with the right partner.
Here’s how BLIRT, an experienced raw material supplier, can design and deliver products tuned to your needs while helping ward off unknown risks!
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Images via Shutterstock and BLIRT