Advancing sustainability in biopharmaceutical manufacturing

The sustainability challenge in biopharma

Biopharmaceutical manufacturing is inherently complex, involving numerous processes that rely on energy-intensive equipment and generate significant waste. One of the industry's most pressing challenges is the widespread use of disposable single-use systems. While these systems reduce contamination risks and increase operational efficiency, they also contribute to a substantial volume of plastic waste.

For example, it is stated that around 30,000 tons of biopharmaceutical single-use products are either landfilled or incinerated globally each year.

"Energy usage is also a significant sustainability challenge for the industry due to the high demand for energy-intensive processes and the use of equipment," Lee said.

The carbon emissions associated with these energy-intensive processes further contribute to the industry's environmental footprint, highlighting the urgent need for action. Striking a balance between sustainability and the strict regulatory requirements governing biopharmaceutical production can be challenging.

In fact, the biotechnology and pharmaceutical sector had a substantial carbon footprint in 2022 alone, with total carbon emissions reaching 193 million metric tons of carbon dioxide equivalent. Compounding this issue, the sector is poised for rapid growth, with the global biotechnology market projected to achieve a compound annual growth rate of 13.9% from 2023 to 2030.

"Compliance with safety, efficacy and quality necessitates a focus on yield, speed and monitoring," Lee stressed.

This regulatory focus can make it challenging for companies to adopt greener practices without affecting production timelines or quality standards. To implement sustainable practices, companies must navigate complex frameworks while maintaining rigorous safety standards​.

The evolution of sustainability in bioproduction

Over the past few decades, the biopharmaceutical industry has significantly shifted toward sustainability. As Lee noted, global awareness of environmental issues has increasingly led companies to prioritize sustainability in their values and operational goals. Stricter environmental regulations, changing consumer demands and corporate social responsibility initiatives contributed to this shift.

One of the most notable advancements in sustainable biomanufacturing is the adoption of green technologies and practices. Innovations such as continuous manufacturing, reducing waste and energy consumption have become more widespread. Continuous manufacturing allows for a more streamlined production process, ultimately minimizing resource usage and waste generation. Additionally, the development and implementation of biodegradable and single-use bioprocessing systems that minimize environmental impact are gaining traction in the industry​.

"The industry's unwavering commitment to sustainability is further evidenced by the establishment of environmental management systems and certifications that ensure compliance with environmental standards," Lee highlighted.

Regulatory complexities and their impact

One of the most significant barriers to implementing sustainable practices in biopharmaceutical manufacturing is navigating the complex regulatory frameworks that govern the industry. Regulations are designed to ensure product safety, efficacy and quality, but they can also hinder innovation by dictating specific materials, technologies and processes that might not align with more environmentally friendly alternatives.

"Achieving regulatory approval for new technologies can sometimes be lengthy and resource-intensive," Lee emphasized.

As a result, many companies might be hesitant to adopt new sustainable practices that could disrupt their existing regulatory compliance. The stringent requirements imposed by regulators often create a difficult environment for innovation, as companies must ensure that their processes comply with safety regulations while striving to reduce their environmental impact​.

Despite these challenges, ongoing dialogue with regulators in conjunction with third-party assessments -- such as the annual EcoVadis review -- helps companies like Sekisui maintain sustainability efforts without compromising their regulatory standing​.

Scaling sustainable fermentation processes

Scaling enzyme and microbial fermentation processes presents unique technical challenges regarding sustainability. To address these, Sekisui has prioritized process development and optimization at small scales, ensuring that their processes become more efficient and require fewer consumables.

"By focusing on process development and optimization at this stage, a manufacturer can ensure that the processes become more efficient and require fewer consumables," Lee stated.

This approach not only contributes to higher product yields at smaller fermentation volumes but also results in a commercial process that is cost-effective and less wasteful​. One way Sekisui achieves this is through advanced in-process analytics, which plays a critical role in enabling sustainable bioproduction.

"Advanced analytics precisely monitor key analytes throughout the process, ensuring the process remains within a defined specification range," Lee explained.

This continuous monitoring allows for proactive adjustments, enhancing yield and optimizing resources while reducing the overall carbon footprint​. Advanced and continuous assessment of key process analytes is crucial in reducing waste and enhancing bioproduction processes' efficiency.

Technological innovations driving sustainability

Technology is pivotal in enabling sustainable biopharmaceutical production without sacrificing efficiency or quality. Sekisui, for instance, integrates sustainability into its operations through KAIZEN initiatives, which focus on continuously improving operational efficiency and reducing waste. This philosophy encourages a culture of continuous improvement, ensuring that every aspect of the production process is regularly evaluated for potential sustainability enhancements. The company also actively captures the environmental impact of its consumables, raw materials and equipment to make informed decisions about sustainability​.

Sekisui's United Kingdom manufacturing site has made significant strides in sustainability, transitioning to using 100% renewable energy for its production processes. This shift has helped minimize the environmental impact of their operations, particularly in terms of greenhouse gas emissions. The company diligently monitors its greenhouse emissions, water usage, waste and recycling, demonstrating a strong commitment to sustainability​. By tracking and managing these metrics, companies can ensure that their operations align with corporate sustainability goals and regulatory compliance.

Moreover, Lee revealed that Sekisui is exploring a range of emerging innovations designed to further enhance sustainability in large-scale enzyme and protein production.

"Sekisui is always on the hunt for innovations that will enhance sustainability while maintaining product quality and specification," Lee reaffirmed.

From reusable chromatography columns to environmentally friendly reagents and buffers, the company continually seeks ways to optimize processes while minimizing waste​. These innovations contribute to a more sustainable manufacturing process and support the biopharmaceutical industry's overall goals.

Achieving a sustainable future in biopharma

Moving forward, sustainability will remain a top priority for many organizations. Companies like Sekisui are leading the charge by integrating sustainability into their operations and investing in innovative technologies that reduce environmental impact while maintaining product quality. The ongoing development of biodegradable materials, continuous manufacturing processes and advanced analytics will play a critical role in enabling the industry to meet its sustainability goals.

To achieve a more sustainable future, Lee underlined the importance of collaboration and ongoing assessment.

"Maintaining ISO standards certification through regular audits ensures a continuous discussion with regulators regarding quality and sustainability," Lee added.

This collaborative approach -- coupled with a commitment to innovation -- will be key to overcoming the challenges that lie ahead​. The industry must continue to push for greater flexibility in regulatory frameworks to support adopting sustainable practices without compromising safety and efficacy.

With continued investment in green technologies, process optimization and collaboration with regulators, the industry can reduce its environmental footprint and create more sustainable practices. By prioritizing sustainability, biopharmaceutical companies have the chance to meet regulatory demands while contributing to a healthier planet for future generations to come.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.