CPHI Barcelona, united the entire global biologics supply chain, with over 40,000 visitors from diverse pharmaceutical portfolios, one paramount topic took centre stage: enhancing biologics efficiency through sustainability. We embarked on this journey with Doug Nissinoff, Senior Research and Strategy Associate at BioPlan Associates, to delve into the latest trends in the adoption of sustainability practices in bioprocessing and explore why it has become a pivotal consideration.

Sustainability: a term that resonates in almost every industry, representing the future we hope to build. This concept, while straightforward, embodies a holistic approach to long-term viability, ensuring that actions today don’t compromise the prosperity of the future. Such is the ethos presented by the World Commission on Environment and Development (WCED) in 1980 [1].

For the biopharmaceutical sector, the path to sustainability has been convoluted. Strict regulations, an uncompromising demand for safety, and immense market pressures meant that product quality often overshadowed sustainable practices. However, a paradigm shift is currently in motion. A review spanning the last 14 years shows a significant increase in the industry’s commitment to sustainability, waste management, and stewardship [2].

Sustainability and process efficiency are interconnected. For many in the bioprocess industry, this should involve:

• “Reduce” process steps as this also – by definition – reduces waste and is more than an eco-friendly gesture; it’s a strategic business decision that can yield both environmental and financial dividends.
• “Reuse” whatever we can, as this will have a multiplier effect compared to recycling. However, the challenge in bioprocessing is that reusing single-use equipment can have severe negative impacts.
• “Recycle” as a last contributor to sustainability, recycling allows the last bit of value to be recovered from a system.

Although recycling is often considered by some to be synonymous with sustainability, in this industry recycling’s contributions are often considered lower in the long-term picture.  Despite this, we can use the segment’s interest in recycling as an indicator of interest in broader sustainability initiatives.

The challenges associated with single-use systems in the biopharmaceutical industry are brought into stark relief when comparing industry opinions on what constitutes ‘proper disposal’ verses the actual practices in facilities. The glaring disparity between the “should-be” and “is” scenarios underscores a profound cognitive dissonance within the sector. A telling instance of this is the overwhelming sentiment favoring the recycling of single-use devices by sending them back to manufacturers; nearly half of the respondents (48.1%) believe this should be the norm, yet a meager 4.9% of facilities implement such practices. This vast gap echoes across other preferred methods like third-party recycling and incineration for power generation.

Fig 1: Single-use Recycling; Respondents’ Desires for Disposal vs Actual Disposal Process (2020 Data)

Source: 20th Annual Report of Biopharmaceutical Manufacturing and Production. April 2023, BioPlan Associates, Inc. www.bioplanassociates.com/20th

Furthermore, while the industry shows a notable inclination toward eco-friendly and sustainable solutions, the existing infrastructure and operations contradict these aspirations. The data reveals a concerning reliance on less sustainable methods: for instance, a staggering 40.7% of facilities resort to incineration as medical waste, despite only 18.5% of respondents seeing this as an ideal practice. Also troubling is the fact that almost one-third of facilities have no choice but to use landfill disposal after autoclaving, with only 14.8% believing this should be the approach.

This divergence between industry sentiment and on-ground actions highlights a pressing need: While awareness of sustainable disposal methods is present, systemic changes and infrastructure investments are imperative to bridge the existing chasm and align actual practices with the collective vision for a greener biopharmaceutical future.

A silver lining has emerged, though. An increasing number of vendors have warmed up to recycling programs. This is more than a mere trend; it’s a testament to the evolving value system of the biopharma supply chain.

Leadership Needed

Leadership is, without doubt, the linchpin of sustainability in this industry. The FDA and EMA have of course set the standard for product quality and, in some cases, this makes sustainability initiatives difficult to implement. Managing that balance creates challenges for leaders. At a recent CDMO summit in Copenhagen, June 2023, BioPlan surveyed 44 global CMC consultants regarding the challenges they saw leaders facing when advocating for sustainable initiatives.  The single most daunting challenge is “Demonstrating an ROI,” followed by the related, “Convincing board to invest in sustainability initiatives.”

Fig 2: #1 Challenge Bioprocessing Leaders Face when Advocating for Sustainability

Source: BioPlan’s survey of 44 biopharma CMC consultants at a CDMO Summit, Copenhagen DK, June 2023.

Sustainability Requires the Ability to Measure Progress

The Leadership Thesis to be considered is that “Sustainability” requires positive outcomes and the ability to measure success. Real sustainability is not just about incremental improvements, e.g., implementing a recycling program, or PR around planting trees or installing solar panels.  It is about changing mindsets and that requires organizational change.

To accomplish this, the data suggest that “Sustainability” will occur in biopharma segments when the focus includes:

• Revenue-positive outcomes (profitable)
• And the ability to measure initiatives’ results (revenue, productivity or efficiency)

Essentially, successful sustainability initiatives will require that leaders demonstrate intent to:

• Change organizational mindsets – in a biopharma facility, that requires leadership
• Demonstrate revenue positive outcomes can significantly improve an initiative’s chances for successful implementation
• Measure outcomes of initiatives to ensure enduring change, not just for an annual report, or PR ‘greenwashing’

True sustainability hinges on the presence and commitment of visionary leaders. It is these leaders who understand the need to prioritize sustainability initiatives that not only drive positive environmental but also generate favorable financial returns. Their leadership establishes well-defined metrics that show tangible impact of sustainability efforts, ensuring they’re more than just superficial gestures.

Leaders play a pivotal role in cultivating a pervasive culture of sustainability within the organization, making it an intrinsic part of its ethos. The real litmus test? Delving into the depths of a leader’s commitment to sustainability and gauging their long-term vision for a more sustainable future.

A long-term model of sustainability in biopharma can be distilled into two key elements:

Profitable outcomes derived from sustainable initiatives.  The ability to quantify the results of these initiatives can be measured through improved efficiencies, which can lead to profitability.

Operational success is often a function of middle management’s ability to act within the bounds of regulations. Empowering these individuals with the right tools and mindset to adopt practices like reusing, repurposing, and recycling can have ripple effects throughout the organization, setting the stage for a brighter, greener future.

The undercurrent in modern sustainability is economic viability. When operations are fine-tuned to minimize waste, there’s an inherent reduction in costs. Such economic incentives are now central to sustainability narratives, blending fiscal responsibility with ecological stewardship.

The mandate for leaders is clear and challenging. It’s not just about oversight but active transformation. This entails securing the commitment of the board, developing a compelling sustainability narrative, and converting overarching strategies into day-to-day operational tactics. The aspiration is to seamlessly integrate economic performance indicators with green initiatives—a balancing act that demands unwavering focus and innovation.

In the final analysis, biopharmaceutical manufacturing requires leaders armed with vision and pragmatism. By developing a metrics-driven, economic, and environmental strategy that maintains the segment’s quality imperatives, the industry can ensure a future that’s both prosperous and green.

References:

[1] World Commission on Environment and Development (WCED). (1987). “Our Common Future.”

[2] 20th Annual Report of Biopharmaceutical Manufacturing and Production. April 2023, BioPlan Associates, Inc. www.bioplanassociates.com/20th