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Modular Cleanroom Technologies Have Always Been the Answer to Biopharma’s Global Growth and Flexibility Needs

Modular building technologies have well proven to meet the pharmaceutical industry’s demanding capacity and speed imperatives.

For the last three decades or more, biopharma’s growth has been nothing short of amazing. From life-changing biologics and monoclonal antibodies (MAbs) to mRNA-based and now cell-based immunotherapy medicines to fight viruses, cancers, and previously incurable diseases elevating biopharma’s position to even greater prominence. Regulatory guidance and approvals of Advanced Therapeutic Medicinal Products (ATMPs) also highlight the assimilation of these advancements in the biopharmaceutical sector.

From recent growth projections, it is evident that the patient reward, demand, and investment in cell therapies will continue to fuel the continuing rapid global expansion of the biopharmaceutical industry. This will require the industry to quickly expand its manufacturing capacity in alignment with the advanced scientific achievements on the verge of a new wave of discovery.

Expanding ATMP capacity is a complex and expensive proposition, requiring enormous outlays of capital, resources and niche experience that can realise the requirements of the inherent novel manufacturing small batch process design methodologies. Although traditional biopharmaceutical manufacturing facilities have always been capital intensive to construct owing to the aseptic cleanroom sterile environments were intuitively rationalised by more efficient (and profitable) large-scale biologic manufacturing processes and their respective facility investments. There was a time when the business/financial case for a particular biologics facility and drug product would prioritise and rationalise a “speed to patient over expense” project strategy for new greenfield capital investments. Smaller-scale production requiring more nimble facility designs has shifted this economic paradigm requiring greater diligence to ensure the long-term value of significant capital outlays. New facilities for highly specialised processes need to be designed and constructed in a manner that accommodates future novel and improved manufacturing processes resulting from a coming wave of therapeutic advances and expected capacity increases.

In 2020, the global biopharmaceuticals market was valued at some $291 billion, according to market research company NextMSC. Dramatic growth is expected note analysts who project the market to increase to nearly $1 trillion by 2030.1 Fuelling overall growth in the sector Visiongain projects the global ATMP market to reach $59.91 billion by 2030.2

Rapidly Deployed Flexible Manufacturing Capacity Needed Fast

Because of the global success of biologic products, industry data clearly shows that the demand for these aseptically processed therapeutics will continue to rise along with the corresponding increase in manufacturing capacity to serve growing patient populations, payer access, as well as the multi-decade appetite for venture capital investment. Biopharma’s response to this demand is drawing an astonishing amount of capital to the sector and with it, a call from the industry for millions of square feet of new, efficient cleanroom manufacturing space to produce the next generation of novel biologics, and sophisticated cell-based manufactured therapies.

With worldwide sales approaching $300 million per year and increasing at ~12% annually, BioPlan Associates’ technical research director Ronald A. Rader explains that growth in bioprocessing supplies and services will also likely keep pace noting that new capital investments in bioprocessing equipment are growing at 8.7% on average.2 He also noted the industry’s bioprocessing sector is extremely dynamic and will continue to expand in revenue, importance and diversity.

Industry analysts confirm that almost all biopharmaceutical and biotech firms outsource at least some of their cGMP manufacturing operational needs. For example, outsourcing final product container vial filling and finishing labelling is a common strategic operational practice enabling capital investment risk mitigation. Following the growth of the biopharmaceutical sector, according to a report by Grand View Research, Inc. the global fill-finish pharmaceutical contract manufacturing market size is projected to grow at a compound annual growth rate (CAGR) of 6.1% and expand to reach $14.0 billion by 2030.3

In the early years, traditional biologic (aseptic) manufacturing processes (e.g. cell culture, fermentation) addressed large markets with applied therapies. Product areas were dedicated, batches were large, equipment automation was applied, and yields were quick to improve.

In perspective, cell and gene cell therapies manufacturing processes generally treat small patient populations and have manual aseptic production techniques that often induce proportionally greater facility design space and flexibility requirements including multi-product manufacturing. Also, these complex processes inherently have yield and scale challenges which impede efficiency and supply initiatives.