CPHI North America 2024

Torbay Pharma: 'We are all about making sterile supply simple'

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Sterile Injectables Contract manufacturing Pharmacology Manufacturing

Torbay Pharmaceuticals is a sterile injectable contract manufacturer and licence holder based in Devon, UK. We spoke with CEO Emma Rooth about the company's heritage and how it is striving to support the U.S. market.

BPR: What new products or innovations is your company showcasing at CPHI North America this year?

We are a CMO focused on supporting the needs of clients looking to bring terminally sterilised injectables to market.

For the US in particular in 2022 48% of all drug shortages related to injectable medicines. The ability to ensure a consistent stable supply of these medicines is key to the US but also many other markets. November 2023 saw shortages reach a record high. This is how Torbay can support the US market and already do so by partnering with a number of key injectable suppliers in the market

BPR: How does your company stay ahead of industry trends and developments in the pharmaceutical sector?

Like all businesses we undertake horizon scanning and we speak to industry experts and clients in the market. We have an extensive network of clients and partners cross the globe who understand the challenges in each country we work in. 

Operationally our area of focus continues to be our business excellence programme. We are continually developing and strengthening our management systems and processes across the organisation to improve performance create value and provide a first-class service for all our stakeholders.

BPR: What challenges is your company currently facing in the pharmaceutical market, and how are you addressing them?

Ensuring that we have a robust, cost elective and reliable supply chain is one of the biggest challenges we face today. The generic manufacturing space is incredibly a competitive environment. We have learned that improving supply chain performance is critical to maintain our competitive advantages. Forecasting, planning, procurement, financing, stock levels, and marketing strategies are areas of the business that we focus on in order not just to remain competitive but to ensure product supply to our clients and ultimately to patients. It is a constant balancing act.

We are continually addressing it through our business excellence program and focussing on key areas such as:

Results and creating value. We focus on key results daily and manage by fact across the entire business. We all know whether we’ve had a successful day.

We also focus on knowledge sharing and learning across the business. Achieving high levels of organisational performance requires a focused approach to personal learning and continuous improvement. We encourage and support all of our TP colleagues to continue learning and introduce better ways of working. We have a ‘we can’ attitude to how we solve problems and maximise on opportunities

We recruit for attitude. Having the right attitudes and capacity helps us succeed in today’s ever changing, globally competitive environment, we can remain agile. It’s our people that make the difference when it comes to addressing the challenges in the market.

BPR: How does your company prioritize sustainability and environmental responsibility in its operations and products?

Climate change is the defining challenge of our generation—and we like most responsible companies are stepping up and have an ambitious net zero plan.

Sustainable operations are part of our holistic effort to drive business growth and excellence.  We are working across the business to improve operational sustainability—reducing emissions across the product life cycle, increasing sustainability in procurement and supply chain, enhancing operational efficiency.

Today the majority of our greenhouse gas emissions come from our supply chain and make up the largest share of our total carbon footprint. We are actively engaged and collaborating with our suppliers to create new sustainable procurement standards that reduce our carbon footprint. 

Being on the path to achieve our emissions targets enables also enables us to stay ahead of new regulations, maintain access to capital, and retain and attract top talent. 

BPR: Can you provide insights into any regulatory changes or compliance issues that are impacting your business?

Regulatory bodies such as the FDA and the EMA (European Medicines Agency) in Europe continually update and tighten quality standards for pharmaceutical manufacturing that affect companies like TP. Compliance with Good Manufacturing Practices (GMP) is essential for companies operating in this space and we view this as a positive as ensuring access to high quality and safe medicines is key.

We are finding that regulatory agencies are increasingly scrutinizing data integrity and documentation practices. Ensuring compliance with data integrity regulations is critical for companies in the generics injectable medicines industry to maintaining regulatory approval and market access.

There has been an increased effort to harmonize regulatory requirements across different regions. Harmonization initiatives if done well have the potential to streamline regulatory processes and reduce barriers to market entry, making it easier for companies such as TP to compete.

BPR: What strategies does your company employ to ensure the quality and safety of its pharmaceutical products?

Our approach to quality and safety links into our business excellence programme. It is number one on our agenda every day at every meeting.

Manufacturing Practices (GMP) and other regulatory requirements is critical to ensuring patient safety. We focus every day on improving safety performance, and fostering a culture of leadership transformation, we want to hear from our colleagues if they spot is a potential risk especially as they often have the best insight and experience to spot any potential issues before they arise. It sits at the heart of our manufacturing and business excellence ethos.

Like most organisations in the industry, we have implemented a robust quality management system that we continuously monitor and develop we also have well thought out risk management plans that help identify and potential issues with appropriate actions in place to mitigate and of course we are continuously ensuring that our colleagues are trained to the appropriate standards to perform their roles effectively and safely.

BPR: What sets your company apart from competitors in the pharmaceutical industry, and what value do you offer?

There are 3 things that set us apart from our competitors.

As a contract manufacture of terminally sterilised injectables we have over 50 years’ experience of manufacturing products that are being requested by clients today. We have a strong emphasis on PN products and essential medicines. Our growth and expertise are being driven by our competitors trying to move up the value chain and focus on more complex medicines. A large proportion of the products that we make today have been used in some cases for over 50 years in emergency departments and theatres around the world. Whilst they may not be new and novel drugs they are used to treat millions of patients around the world every day.

Due to our heritage and background, we have over 12 years’ experience of filling into plastic vials which can be challenging to achieve and do well. There is an increasing demand across the globe for expertise in filling the type of products we manufacture into plastic. To meet the growing demand, we have invested over millions of pounds in installing a new line capable of meeting the demand we are seeing for filling into plastic.

Our people are our biggest asset in setting us apart from the competition. We have amazing, talented, and dedicated colleagues that live our attitude of 'we can' every day. Without the commitment of all team TP colleagues, we would not be able to create the value and provide a first-class service to our CMO customers. We are all about making sterile supply simple.

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