A successful in vitro diagnostic (IVD) supply chain is only as strong as its weakest link – which is why, at Medix Biochemica, we take steps to ensure a reliable and robust supply chain.1
The Critical Role of Hormones as Raw Materials in IVD Diagnostics
Hormones are used in IVD testing to enable the diagnosis, treatment and prevention of various hormonal conditions.1 IVD tests are used to determine the levels of reproductive hormones, thyroid hormones, adrenal hormones, pituitary hormones and more.2
The Fragility of IVD Supply Chains and the Need For Resilience
A successful IVD assay or test requires multiple reagents to do its job, including raw materials, consumables and equipment. It’s essential that each one of these materials comes from a reliable supplier and offers the highest possible performance and reliability. This is where Medix Biochemica steps in.1
How Medix Biochemica Ensures a Robust Supply Chain
An all-in-one supplier and partner
If just one of the elements needed to produce an assay is unavailable, the entire production process will come to a standstill. That’s why Medix Biochemica provides a wide variety of reagents, from antigens, antibodies and enzymes to proteins (hormones), biologicals and base matrices.3
Forecasting and mitigating supply disruptions
Disruptions can occur in delivery and lead times when, for example, a supplier goes out of business or is no longer able to supply a raw material, or when import/export issues arise. Medix Biochemica prioritizes R&D with customer needs in mind, so we’re able to keep one step ahead and mitigate these delays. If a customer need arises from an unexpected issue, we have the R&D capabilities to prioritize and meet this unplanned demand.1
Because we’re ‘in the middle’ of the supply chain, we’re in a unique position to coordinate information from our suppliers and customers and proactively devise solutions before potential issues become a problem.1 We can warn our clients about impending shortages and other challenges, and suggest workable solutions.1
An example of supply disruption and a Medix Biochemica solution:When African Swine Fever seriously affected the world’s pig population, and any porcine-derived reagents were hard to come by, Medix Biochemica was able to assist customers with alternative sources of these reagents.1 |
Ensuring scalability to meet increased demand
We keep our customers’ supply chains in motion by being 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.1
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During the COVID-19 pandemic, we proved our scalability by quickly and efficiently meeting the dramatically increased demand for biospecimens used in our customers’ test kits.1 For example: In the early days of the pandemic, we received a request to produce a kilogram of an antibody which binds to human IgG. With our highly scalable cell culture process and production capacity, we were able to meet this requirement. According to this large multinational customer, Medix Biochemica was the only antibody supplier able to accommodate this request, “and we asked everyone”. |
Understanding our customers’ needs ahead of time allows us to keep our processes streamlined and cost-effective.1
Clear, future-driven communication:We communicate openly with customers and make sure we understand their long-term needs. For example, a customer might tell us that they want 10 mg of a material per month, gradually scaling up to needing 150 mg of that same material per month by the end of the year. We work with our customers’ long-term needs in mind and ensure we produce the quantities needed in bulk ahead of time, so that we can meet the increased demand when the time comes.1 |
Providing consistency and reliability
Medix Biochemica excels at batch-to-batch consistency, preventing supply disruptions that can be caused by inconsistent reagent performance. We do this through rigorous quality control, testing the functionality of each batch and comparing each batch to a previous one.1
Collaboration as a key solution to supply-chain challenges
We collaborate across all phases of the supply chain to meet our customers’ needs, e.g.:1
- When the customer has an idea but not the product they need (new or customized), we can work together to generate that product for them.
- If a client has purchased an off-the-shelf product from us and is having difficulty with its implementation, we can collaborate to troubleshoot this with them.
- We provide regulatory support by being open to, and ready for, auditing.
This collaborative approach ensures that Medix Biochemica is easy to work with throughout the customer journey.1
Understanding the changing IVD landscape
Adapting to a changing landscape of AI:
Currently most of the AI being used in the industry is geared towards laboratory management systems, to enhance efficiency in the day-to-day manufacturing process. Knowing that AI has the potential to change raw material demands in the future (e.g. to increase the demand for more sensitive antibodies), the Medix Biochemica team is confident that we can adapt to meet the evolving needs of the market.1
Anticipating the rise of at-home testing:
At-home IVD tests are popular due to the convenience and privacy they offer. It’s become more common for test developers to create assays with the home-testing application in mind. We collaborate with customers who are making the shift towards producing at-home tests – understanding whether our products will be used in this way helps us to better meet the customer’s needs.1
Our Collaborative Process: How it Works
A key member of Medix Biochemica will work closely with the customer to understand what they want to develop. We grow each relationship and have standing meetings with customers on a routine basis. During these meetings, we’re able to keep the customer up to date, uncover more of their needs and liaise with the team members who can solve these needs (e.g. a technical team). We keep all communication transparent and share any negative news honestly and promptly.1
On the other end of the supply chain, we also have close relationships with our raw material suppliers, and this helps us to keep our finger on the pulse of the industry.1
Our collaborative approach is what sets Medix Biochemica apart from our competitors and allows us to act as a strong, reliable link in the IVD supply chain.1 We look forward to helping more customers to grow and succeed with this approach in the years to come.
References:
- Expert opinion. Interview with Anthony Austin, Global Marketing Manager, Medix Biochemica. April 24, 2024
- Hormone levels information. Mount Sinai Health System. Accessed April 30, 2024. https://www.mountsinai.org/health-library/tests/hormone-levels.
- Medix Biochemica: A critical raw material manufacturer for the in vitro diagnostic market. Medix Biochemica. 2024.
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