Q&A with Merck: Supply chains during Covid-19

EPM speaks to Chris Ross, head of Life Science Integrated Supply Chain Operations at Merck to discuss the company's response to Covid-19 and the challenges in developing and supplying vaccines.

What’s Merck doing to support Covid-19 efforts? 

We’re supporting the global scientific community in the response to Covid-19 by providing the necessary products and services for virus research and detection along with the development of therapies and vaccines. Each of these areas is critical in slowing the progression of Covid-19, and ultimately, treating and protecting people in the future. Overall, we offer approximately 200 products for scientists working on Covid-19 research and potential vaccines.

We continue to support many of our customers working on Covid-19 projects, including:

• More than 25 testing solutions (including RT-PCR and serological diagnostics for both high-throughput centralised and distributed point-of-care settings), including eight of the top 10 IVD market leaders.
• More than 45 different vaccine candidates, consisting of several platforms that include DNA, Inactivated, Live Attenuated Virus, Viral Vector, Protein Subunit and mRNA.
• More than 20 monoclonal antibody, plasma products and antivirals.

Collaboration is critical to accelerating solutions in response to Covid-19, which is why we are part of multiple collaborations across the industry, including:

• We are collaborating with The Jenner Institute to scale-up the manufacture of its Covid-19 vaccine candidate. Our role supports process development and scale-up at 10 liters for downstream unit operations and preparation for further scale-up efforts and technology transfers to contract manufacturing organisations.   
• Our collaboration with Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine Development is working to advance process improvements for the manufacturing of two Covid-19 vaccine candidates in parallel: a novel Covid-19 vaccine candidate (protein-based) and a repurposed SARS vaccine candidate. We will focus on improvements to production efficiency, yield, robustness, scalability and costs for both vaccine candidates.
• As a member of the Gates Foundation Accelerator, we are contributing to discussions focused on our key areas of focus: vaccine manufacturing capacity sharing and diagnostics. These conversations are in the early days and we are working to outline next steps in the Accelerator. Across the businesses of Merck KGaA, Darmstadt, Germany, our parent company, we are contributing in additional workstreams. 
• We have partnered with MIT on a collaborative effort using MIT’s Center  for Collective Intelligence  software platform and the global life science ecosystems of both our company and MIT Media Lab’s Community Biotechnology Initiative to crowdsource expertise and answers in crucial areas for pandemic response. By tapping into the networks empowered by this group’s combined technology, global reach and crowdsourcing knowledge, and ideas, this multi-faceted initiative can spearhead efforts to combat the Covid-19 pandemic, accelerate global recovery and establish infrastructure capable of handling future public health crises.  

How much effort does it require to co-ordinate supply chain efforts in relation to the number of companies currently receiving your products?

Our experienced teams were able to adapt quickly to changing conditions to ensure we’re meeting the needs of our customers working on Covid-19. As an example, we supply many of the largest vaccine manufacturers and are one of the leading suppliers of single-use assemblies for bioprocessing. 

Our Supply Chain & Distribution Task Force meets twice weekly, working to ensure products specifically supporting Covid-19 are prioritised while building business continuity plans. Our Integrated Supply Chain Operations team is increasing capacity with a three-pronged approach to rapidly commission new space and accelerate capital investment, procure raw materials and acquire needed talent.  

What work has Merck done to adapt its manufacturing capacity to supply products for Covid-19 projects?

We are not new to acting with an agile but rigorous mindset. We are leveraging best practices from our global sites to ensure no shortages occur. For example, we are increasing the stock of products sourced and activating our validated secondary suppliers in accordance with our quality procedures where necessary. 

One of our top priorities at this time is the safety and well-being of our employees, and we’ve taken important steps to ensure site safety. This means some sites’ operating productivity is not at 100% due to implementing social distancing rules, disinfecting protocols and other necessary procedures. Because of this, some high-demand products must follow our allocation principles, which prioritise customers working on Covid-19 and other life-saving treatments.

We are leveraging our current capacity while accelerating our hiring of needed talent and capital investment in process plants and equipment.

If a vaccine is produced, is there currently enough manufacturing capacity to produce enough doses quickly and effectively?

If vaccines were to be approved and expected to scale up within the next three to four months, we would most likely see reagent/component shortages and manufacturing footprint as a critical bottleneck. 

However, while vaccine companies are striving to obtain approval in the next 12 months, we are working in parallel with the vaccine developers to better understand their needs and ramp up capacity. Internally, we are developing demand models for different vaccine modalities to anticipate any supply challenges. 

Additionally, single-use equipment, such as our Mobius solutions, provides an opportunity for rapid scaling. It can quickly be put in place at a lower cost than traditional stainless-steel equipment, which is key during outbreaks such as Covid-19. Single-use equipment also has quicker implementation time and lower costs. 

Finally, rapid scale-up using Good Manufacturing Practice (GMP) systems allows many manufacturers to leverage their existing capacity versus building new sites. 

Are there any current technological barriers to developing vaccines today?

These challenges vary depending on the vaccine modality. 

For established modalities such as mABs, scale-up challenges are upstream titers and downstream efficiency. mABs are better positioned for rapid scale up. 

Viral vector platforms are largely unproven and have never been scaled to millions of doses. Due to a lack of purpose-built equipment/consumables for viral vectors, processes tend to be complex, inefficient and hard to scale. Larger companies with existing viral vaccine platforms can overcome these challenges more quickly.

Have the collaborative efforts throughout the industry come as a surprise? 

We are seeing these efforts move much faster, and it appears the appetite to move swiftly for public health is welcomed by all parties. We always make sure that our partnerships with industry players meet our goal of collaborating with the global scientific community and accelerating access to health.