How is sustainability shifting from a reporting exercise to a design constraint in manufacturing and development?

Sustainability is increasingly becoming part of how we think about operational and technology design, rather than simply a reporting exercise. When you look at sustainability in the context of the global supply chain and the needs of the therapy space around cost, manufacturability and sustainability, these factors are becoming closely connected.

As access to therapies expands across different regions and regulatory agencies, operational excellence and sustainability need to be built into the design. If you’re using a technology that has higher waste and throughput but lower output, you’re not only negatively impacting sustainability but also your ability to create access to healthcare.

Conversely, if you can introduce new technologies that have a lower operational footprint but multiply output, you can positively impact both sustainability and the end commercial product for patients. That’s why, from a technology design, manufacturing and development perspective, sustainability is a quintessential element to consider.

When technology design can enhance throughput while reducing capital outlay or resource utilization, you not only improve products for patients, but also enhance sustainability.

From WPT’s perspective, sustainability is increasingly becoming an operational consideration that is built into process and manufacturing decisions from the beginning, rather than something addressed primarily through reporting.

In process development, this means looking beyond yield alone and considering factors such as solvent and reagent selection, waste generation, energy consumption, purification requirements, and overall process efficiency. A process that delivers a high yield but requires excessive solvent volumes, multiple isolations, or energy-intensive operations may not be the most sustainable or scalable option.

As a CDMO, we see this becoming particularly important during scale-up. Decisions made during development; such as choosing a more efficient reaction pathway, reducing solvent usage, improving crystallization, or minimizing the number of processing steps; can have a significant impact on the environmental footprint and economics of manufacturing at larger scale.

Technology also plays an important role. More efficient analytical and process technologies, improved purification strategies, automation, and better process understanding can help reduce material consumption, processing time, and waste while maintaining quality and regulatory requirements.

Ultimately, sustainability is becoming another design constraint alongside yield, quality, safety, cost, and scalability. The goal is not simply to measure the environmental impact of a process after it has been developed, but to incorporate those considerations into the chemistry and manufacturing strategy from the outset.

At Astrea Bioseparations, we see sustainability moving beyond simply measuring and reporting environmental impact. It is increasingly becoming a design input, shaping the materials we select, the technologies we develop and how we manufacture at scale.

That starts at the product level — our PuraBead^® agarose resins are derived from renewable seaweed and manufactured using an atomization process that avoids organic solvents. We are also designing processes around greater efficiency, including water recirculation, tighter process control and reduced waste.

The same thinking extends into technology development — AstreAdept^® nanofiber technology enables process intensification, reducing equipment footprint, water use and waste, while our Evolve^® Process columns and Refresh Kits are designed so that components can be retained and reused rather than unnecessarily discarded.

Ultimately, sustainability is becoming another engineering constraint alongside quality, performance, scalability and cost. The opportunity is to design those requirements together from the outset, rather than addressing environmental impact after the process has already been developed.

Pharmaceutical manufacturing and testing have traditionally relied on resource-intensive processes. However, embedding sustainability principles into operations as part of a broader modernization effort increasingly allows industry to reduce waste, lower carbon footprints, support biodiversity, and accelerate innovation.

Industry leaders recognize the need to reduce environmental impacts while increasing operational efficiency. Innovator pharmaceutical companies expect suppliers to meet high standards for energy and water use, among other sustainability goals. Yet there is still a need for global harmonization of environmental sustainability requirements to reduce fragmentation and ensure broader industry alignment.

One of the resolutions adopted by the USP Convention in 2025 calls for USP to help foster environmental sustainability across the drug product life cycle. Our priorities include revising standards to integrate new technologies, reduce environmental footprint, remove animal testing, and identify modifications that can minimize the use of natural resources in quality testing, such as the adoption and scaling of manufacturing approaches like pharmaceutical continuous manufacturing.

Because pharmacopeial standards are used by tens of thousands of medicine manufacturing facilities worldwide, even small revisions can have an outsized, system-wide impact, shaping practices globally.

Sustainability is evolving from a reporting exercise to a design principle, particularly in early clinical manufacturing. Rather than measuring environmental impact after the fact, development teams are increasingly building sustainability into manufacturing strategies from the outset. This is driving the adoption of small-batch, fit-for-purpose manufacturing models that align production more closely with early phase clinical trial demand. By producing only the quantities needed, manufacturers can reduce consumption of valuable APIs, excipients, packaging materials, storage resources, and the volume of unused product requiring disposal. Combined with more efficient formulation development and streamlined supply chains, this approach helps minimize waste while maintaining the flexibility, speed, and quality required for early phase drug development.

Sustainability considerations are also influencing formulation development, where improved formulation screening and optimization can reduce the number of manufacturing iterations needed to support a clinical program. More efficient development pathways help limit material waste and resource utilization while accelerating decision-making.

Additionally, localized manufacturing and supply models help reduce transportation requirements and supply chain complexity. As a result, sustainability is no longer viewed solely as an ESG reporting obligation but as a factor embedded in operational, process, and technology decisions from the earliest stages of drug development.

Sustainability is increasingly becoming a consideration early in product development and manufacturing, driven by customer requirements and evolving regulations.

This requires balancing sustainability goals with cost and supply considerations for materials that meet more stringent requirements. We're seeing greater demand for recyclable materials, specific virgin material requirements, and changes in the chemicals used in manufacturing. For example, environmental concerns have led to the restriction or discontinuation of certain chemicals, including PFAS, requiring manufacturers to evaluate alternatives and adapt their processes.

Integrating environmental sustainability into medical devices directly impacts verification, validation, and risk management requirements. Manufacturers must demonstrate that material or process changes do not compromise patient safety, sterility, or clinical performance. These efforts may also require additional biocompatibility testing and clinical evaluations, increasing both cost and time to market.

We work to incorporate sustainability into processes, from the beginning which aligns with our core values of customer focus and integrity — to help customers navigate manufacturing challenges and achieve the best outcomes.

As global regulations and requirements continue to evolve, transparent collaboration with customers and vendor partners is essential. By addressing these considerations early and aligning on priorities, manufacturers can make informed decisions that support more sustainable manufacturing while maintaining quality, performance, and scalability.

Within Codis, sustainability has been central to our operations for decades and is increasingly influencing how amorphous solid dispersions (ASDs) are developed and manufactured. Historically, sustainability focused on tracking metrics, such as energy consumption, waste generation, and emissions, for ESG reporting. Today, environmental performance is becoming a design consideration from the earliest stages of product and process development.

For example, when developing ASD formulations, decisions around polymer selection, solvent usage or recycling, process yields, and manufacturing routes can significantly impact resource consumption and waste generation. Process development teams are therefore challenged to optimize formulations and scale-up strategies that minimize material losses while maintaining product performance, bioavailability and quality.

Technology selection is also increasingly driven by sustainability objectives. Investments in advanced process controls, process analytical technology (PAT), digital monitoring, and predictive maintenance can improve batch success rates, reduce rework, and lower energy consumption. Likewise, equipment procurement and facility upgrades are increasingly assessed against both operational and environmental criteria.

As pharmaceutical customers place greater emphasis on supply chain sustainability and carbon reduction, Codis demonstrates that sustainability is embedded within its development and manufacturing approach, supporting the evolution from a reporting requirement into a fundamental constraint driving innovation, investment decisions, and long-term operational competitiveness.

Sustainability is increasingly moving beyond disclosure and reporting to become a practical design constraint across manufacturing and development. As decarbonization expectations and energy costs intensify, environmental impact is being considered earlier in decisions about technology, investment and supply chains. In energy-intensive sectors such as glass manufacturing, this shift is particularly visible.

In today’s manufacturing environment, a business roadmap aligning long-term value creation with the practical requirements of industrial transformation, reducing environmental impact while maintaining product quality, reliability and operational performance is necessary.

Our stated commitments to reduce CO₂ emissions by 42% between 2022 and 2030 illustrate this approach. For example, our 10 global manufacturing sites are all certified to ISO 14001 and ISO 50001 thus ensuring strong environmental and energy management practices.

Reducing emissions depends on continuous improvement in glass melting technologies, equipment, and processes. To support this, more than 130 technology-enhancement opportunities have been identified for implementation by 2050, such as furnace rebuilds and upgrades guided by best available technologies and balanced against environmental performance, quality, and efficiency.

At the same time, increased digitalization and automation drive productivity gains and improved energy performance. Initiatives across the manufacturing supply chain include optimizing logistics, prioritizing maritime transport over road and air freight where possible, improving truck loading efficiency, and engaging lower-emission transport providers.

Target validation is moving from single-assay proof to convergent evidence. Human genetics, especially Mendelian randomization with protein quantitative trait loci (pQTLs), points to causal direction. Single-cell and spatial methods show which cells and tissue niches carry the signal. What is still under-sampled is the layer the drug actually meets: the protein.

Transcript levels are a weak proxy for protein levels, and they say nothing about cleavage, modification, localization or complex membership, which are often what decide function. Proteome-wide measurements, increasingly at single-cell and spatial resolution and in archived patient tissue, let us test whether a genetically nominated target is present, altered, and active at the disease site.

The second shift is druggability. Chemoproteomics now maps ligandable sites and target engagement across thousands of proteins in cells, and flags off-targets early. The question changes from "is this target relevant?" to "can we engage it, and what else do we hit?" before a program is committed.

AI will help integrate these layers, but only if the inputs are functional measurements of the relevant molecular forms rather than proxies. Teams that pair genetic causality with protein-level evidence will drop weak targets earlier and back strong ones with more confidence.

Sustainability is increasingly shaping how processes, facilities, and even cell lines are being built. Traditional CDMO cell line development platforms were designed for earlier generation biologics, and subsequent productivity gains are reaching their limit. Higher performing cell lines now offer a direct route to lower environmental impact: more product per liter allows the same output from smaller bioreactors, reducing CAPEX, as well as energy, water and consumables, a direct contribution to the sustainability targets to which CDMOs are now held.

From the perspective of Prolific Machines, our light-enabled, or optogenetic, technology can be integrated into existing stainless steel or single use formats without major rebuilds, allowing manufacturers to improve sustainability without disrupting operations. In practice, this makes sustainability not just a reporting metric, but a design principle that directly shapes how modern biologics are developed and manufactured.