Andy Whittle, VP Manufacturing at QuantuMDx, discusses the highs and lows of scaling up to manufacture, during a global pandemic.
What is your background?
I’ve over 20 years manufacturing experience, focusing primarily within life science and medical devices. I worked for over 15 years in both large corporate companies such as Thermofisher and Novartis, as well as multiple starts up, where I’ve held the positions of Site Leader & VP/Head of Manufacturing. I thrive working in rapidly growing companies from start-up to large corporation. Taking multiple products from development through to mass manufacture, both in-house and within external manufacturers.
What is your role at QuantuMDx?
My role is VP of Manufacturing and I’m responsible for establishing the company’s manufacturing strategy. This involves identifying and securing the required contract manufacturing partners, as well as successfully manufacturing our Q-POC™ instrument and our lab assay test products.
QuantuMDx rolled out a lab-based test in response to the covid19 pandemic. How did that affect your existing plans?
We were busy working with our development and potential CMO partners on the Q-POC™ system, finalising the component and assembly design. So we needed to put a plan in place to ensure that these core activities could continue, whilst also managing a focused team to respond to the pandemic and take our new SARS-CoV-2 lab test from design and development, through to manufacture and delivery of a CE-IVD marked product.
What were the challenges you faced scaling up for manufacture of the lab based sars-cov-2 test?
From working with our partners on the Q-POC™ system, we were able to very quickly identify the most suitable partner and proactively engage with them, whilst our excellent assay team worked in parallel to finalise the development. Working on a CoVID-19 assay with our partners made us all get aligned very quickly. There was a common goal and we all worked extremely hard to bring to market our assay as quickly as possible with scalable production.
What was the role of supply chain partners? How did you work with them?
As we do with our core CMOs, we worked to established and detailed requirements, to ensure our expectations were well aligned given the need to deliver a new product within a particularly tight time frame, whilst also overcoming shipping challenges brought about by the pandemic.
What lessons have you learned so far?
The importance of developing a sound relationship with all partners within the manufacturing/supply chain. The key being clear and frequent two-way communication, and working to resolve any issues encountered quickly and amicably.
Q-POC™ is QuantuMDx’ flagship point of care diagnostic product, scheduled for release by early next year. What is your department’s role in commercialisation?
We cover a wide range of activities including establishing component specifications, key input in process failure mode analysis (pFMEA) and working with our CMO partners to review and input against validation and batch manufacturing documentation. We’re also involved in assessing and testing delivered products against product specification, feeding back required changes, and supporting our CMO partners with production scale up and trouble shooting.
Is the COVID-19 pandemic affecting supply side issues for Q-POC™ and cassette production?
We have noticed increased instability of supply across different industries. Hence, it’s key to understand production/equipment lead-times and ensure effective stock control with our suppliers, to mitigate potential stock outs. To date we have not been impacted, but that’s only thanks to careful management and planning.
From a manufacturing perspective, what are the pitfalls of scaling up that we need to be aware of?
Scaling production is always a good challenge. A key focus has been on optimising our design for manufacture. This approach has already enabled us to increase injection mould cavitation and semi-automate the production process.
Conversely, what are the opportunities ahead for QuantuMDx?
The opportunities are absolutely endless, to be honest. The pipeline of assays to go onto our platform is strong and will address a wide number of markets. Manufacturing strategies are already in place to meet the growth expectation of our business. I’d encourage anyone to keep an eye on our recruitment if you want to join an exciting, challenging and growing company.