Eric Fua, Conference Producer, IMAPAC UK, investigates the challenges and opportunities facing the biomanufacturing industry.

Last year, the global biomanufacturing market surged to an astounding US$19.02 billion, signifying the sector’s potential to revolutionise global health.1

Biopharmaceutical manufacturing (or biomanufacturing) is today defined by innovation, and is sustained by a growing demand for biopharmaceuticals, vaccines, and therapies. Typically, the United States has dominated in this arena; however, the United Kingdom and Europe are becoming progressively competitive.

The importance of developing effective, scalable vaccines came to the fore in recent years. The pharmaceutical potential inherent in biomanufacturing, however, covers a far broader scope than vaccines alone, expanding into fusion proteins, amino acids, and biopharmaceutical products such as cell and gene therapies. New treatments have been approved in months rather than years, and manufacturing capacities have been added in a quarter of the usual time.2 However, not all this growth can be sustained, and this is where challenges arise.

A bump in the road

Risks and challenges vary based on commercial maturity and stage of innovation. Some manufacturers are dealing with pending patent expirations, whereas others are working within capital constrained environments. The emergency status of the pandemic saw a surge of demand and investor focus into biomanufacturing. However, much of this focus has since reduced and biomanufacturers face a tougher regulatory environment.3 The key challenge, or opportunity, comes down to ensuring operational efficiency across all areas of the business.

A healthy outlook

Despite a slight dip in biotherapeutic approvals in 2022, biopharma innovation remains healthy, as evident from a clinical pipeline boasting over 20,000 active drug candidates globally.4 Personalised medicine and the rise of biotechnology and biopharma startups have driven this innovation. If anything, the emergency of the Covid-19 pandemic underscored biomanufacturing’s strategic importance to national and international health and security.5

The United Kingdom stands as a biomanufacturing powerhouse, with Life Sciences contributing over £94b to the economy in 2021.6 Just this year, Sherlock Biosciences unveiled a biomanufacturing facility in Cambridge, and in May the Government revealed a Biomanufacturing fund worth up to £38m. The fund is set to incentivise investment and improve the UK’s resilience to any future pandemics. £10m has also been announced to drive projects in cutting edge medicine manufacturing that can bolster the UK’s health resilience.7

Tackling challenges with technology

Biotherapeutics now represent over half of worldwide pharmaceutical sales and one-third of all products in development.8 As an unprecedented number of breakthrough treatments are expected,9 effective end-to-end value chain management is more important than ever.

The most significant opportunities for biomanufacturing lie in technological and digital tools. Inherently, biomanufacturing is itself characterised by advanced technologies, harnessing the scientific advances driven by R&D.10 Scalability has always been a challenge for the sector, however proven use cases of digital and analytics tools are making the vision of the biomanufacturing plant of the future achievable.11 It has been reported that a global biomanufacturer, following the implementation of ten technology use cases along the site’s value chain, helped the company increase plant output by 40 percent and the capacity of its quality lab by 50 percent. Deviations were also reduced by 80 percent and manufacturing conversion costs fell by 20 percent.12 It’s clear that technology is critical to the sector’s success.

Collaboration is key

Biomanufacturers that have taken the lead in the industry have the advantage of intellectual property and expertise. However, others in the sector do not have to miss out due to a lack of industry standing. Strategic collaboration can be critical to further success of any company. At each stage of development and commercialisation, novel treatments require different approaches and tools that an organisation may not be readily equipped with.13 Often, the tools to ensure growth and distribution of a new treatment can be provided by manufacturers or technology providers ready and waiting in the wings.

Many of the technological advancements within the biopharma manufacturing space can only develop through prolific research and – crucially – the exchange of knowledge. Discussion around the development of new applications, efficiency-enhancing technology, and vital employee training will allow biomanufacturing companies to enhance their productivity and broaden their scope, while also overcoming key industry challenges.

Funding and alliances

By working together to pool capital and resources, biomanufacturing companies can optimise their capacity to develop products that can be rolled out quickly and on an international scale. Due to current market conditions, the industry is showing preference to accessing innovation through alliances and partnerships – rather than acquisition. In fact, life sciences companies signed alliance deals to the value of US$132.1 billion over the course of 2022.14

Keeping agile

Thanks to advancements in technology, biomanufacturers can take steps toward improving all aspects of their value chain, and efficiency and agility in adopting such tools will be integral to keeping up with demand. Collaboration and partnership are also vital to ensuring the scalability and delivery of biopharma treatments globally – it is only with cooperation that the industry will continue to thrive.

References: WT.mc_id=10851677&AA. WT.mc_id=10851677&AA. WT.mc_id=10851677&AA.