Scalability at Medix Biochemica: From Milligrams to Kilograms

Scalability in the in vitro diagnostics (IVD) industry is crucial for allowing businesses to grow and adapt to market changes. By offering scalable solutions, Medix Biochemica meets our customers’ evolving needs and helps them to stay competitive in this cutting-edge industry.¹

Defining scalability

Scalability is the measure of an organization’s ability to provide products or services at an increased pace or on a larger scale without major changes to its infrastructure. A scalable business can increase or decrease its output according to changes in customer demand without compromising quality, efficiency or batch-to-batch consistency.² 

Medix Biochemica’s scalability ensures that our customers can start small and then grow their operations as demand grows, realizing the efficiencies and cost savings that come with increased scale.¹

How we ensure scalability 

Here are the practices Medix Biochemica has put in place to allow for excellent scalability, providing our IVD raw materials in batch sizes ranging from milligrams to kilograms:³

• We have a stringent quality-management system, manufacturing to high quality requirements. These include ISO 13485:2016 or ISO 9001:2015, as applicable.
• With our state-of-the-art production equipment, we can produce large batches of antibodies, antigens, and molecular diagnostic (MDx) reagents with the highest quality and batch-to-batch consistency. See the picture below for one processing tank we utilize for clinical enzymes!
• We have flexible manufacturing systems which allow us to meet the needs of a dynamic and fast-changing market. For example, during the COVID-19 pandemic we diverted our resources to meet the urgent needs of our customers, with the help of our established network of partners.
• We operate below full capacity to allow unforeseen surges in demand.
• We are customer focused, providing expert-to-expert communication. 

Contact us to discuss your IVD solution needs

The benefits of scaling production

Scalability is important because it has the following key advantages:²

Adapting to marketplace changes quickly and efficiently:

A scalable business can rapidly adapt to changes in the marketplace by increasing or decreasing production. For example, if there's a sudden surge in demand for a specific monoclonal antibody (mAb), Medix Biochemica can quickly increase production to meet this demand without sacrificing our product quality or production efficiency. 

Maintaining high customer-satisfaction levels:

A scalable business can quickly add more resources to its infrastructure during periods of high demand, ensuring that customers can always access the products and services they need. Customers benefit from the convenience and flexibility of product scaling, improving customer loyalty. Being scalable also means the business avoids wasting resources on unused capacity. 

Stable pricing:

Successful scaling means a company can increase or decrease production without incurring significant extra costs. 

Because Medix Biochemica is a scalable company, we can leverage our robust manufacturing processes and flexible production capabilities to provide IVD raw materials that meet the growing demands of our customers.¹

Maintaining agility to meet increases in IVD product demand

We take the necessary steps to ensure a strong and reliable supply chain, staying agile and offering the ability to scale up quickly to meet any increase in demand. Open customer communication and forecasting play a big role in this capability.⁴

Medix Biochemica’s research and development (R&D) capabilities 

The scientific professionals at Medix Biochemica have decades of experience in the development of essential raw materials for diagnostic applications. With one in five employees dedicated to the design and development of new products, we’re able to keep up with all aspects of the IVD industry and scale our offerings quickly and efficiently. Our customer-centric approach makes us the ideal partner to meet your needs.⁵

Scalability enhances supply security and alleviates the challenges associated with revalidating after switching vendors or developing new processes. At Medix Biochemica, we have numerous unit operations and the years of expertise needed to develop, optimize and scale up just about any protein required by our customers.¹

Discuss your bespoke requirements with us: our experienced R&D and analytical teams will tailor or scale up processes to deliver the right product and solutions for your final application.⁵

References:

1. Expert opinion. Anthony Austin. Global Marketing Manager, Medix Biochemica. December 2024.
2. What is scalability? (With importance and challenges). Indeed. Accessed January 7, 2025. https://ca.indeed.com/career-advice/career-development/scalability.
3. Seamless test approval and timely market introduction. Medix Biochemica blog. Accessed January 7, 2025. https://articles.medixbiochemica.com/seamless-test-approval-and-timely-market-introduction-medix-biochemicas-advantage.
4. How Medix Biochemica enhances the resilience of hormone IVD raw material supply chains: Part 1 - The power of collaboration. Medix Biochemica blog. Accessed January 7, 2025. https://articles.medixbiochemica.com/how-medix-biochemica-enhances-the-resilience-of-hormone-ivd-raw-material-supply-chains-part-1-the-power-of-collaboration.
5. Our scientific approach to IVD innovation. Medix Biochemica. Accessed January 7, 2025. https://www.medixbiochemica.com/about-us/our science.