Strengthening pharma’s sustainability foundation

April 8, 2024
New tools can help seamlessly integrate sustainability into R&D and production goals

When it comes to evaluating the pharma industry’s collective progress on environmental sustainability, it’s difficult to form a consensus. Lack of concrete targets for measuring progress as well as a lack of standardization when it comes to reporting that progress have led to a disjointed picture of pharma sustainability.

Furthermore, there is a wide gap between pharma companies that have strong climate-focused sustainability strategies, versus those who are laggards. In fact, a 2022 analysis of the top 25 pharma companies reporting ESG scores by medical device provider Owen Mumford revealed a variance of 40% between the industry’s best performers and those at the bottom of the list.

But the days of disparate ESG efforts and progress for pharma companies are swiftly coming to a close. Europe has advanced pharma-specific regulations, as well as broader corporate regulations, that define, mandate and enforce progress.

“The regulatory developments in Europe, including the EU pharma legislation reform, as well as industry-agnostic sustainability regulations, such as the green claims or the industrial emissions directive, are shifting from a duty of reporting to a duty of effort and a duty of progress,” says Kami Krista, co-founder and CEO of Elio, a startup aiming to become an ‘AI co-pilot’ for sustainable drug manufacturing.

In the U.S., the SEC recently adopted new climate disclosure rules which require public companies to disclose climate-related risks that are likely to have a material impact on business, as well as outline their processes for identifying, assessing and managing these risks.

While pharma has historically been hesitant to change its development and manufacturing processes lest they fall out of compliance with the industry’s strict regulatory standards, these new environmental regulations, combined with emerging business incentives, are shifting the industry’s mindset.

“Right now, we are talking to bigger pharma companies and suppliers and it's very clear that internally things are changing,” says Krista. “They're in this interesting position where they are risk averse, but at the same time, there are new risks associated with inaction from a regulatory and competitiveness standpoint, which are beginning to change their cost calculation for sustainability.” 

In Europe, hospital procurement systems are changing to include sustainability in their purchasing criteria. Tendering, which is the bidding process by which many hospitals in Europe mass purchase drugs, now increasingly includes an ESG component, such as in the Nordics and the UK’s NHS system. (IQVIA estimates that tendering accounts for around 40% of drug purchases in Europe, and in many countries almost 100% of drug purchases in the hospital channel.) This means that pharma companies with more sustainable drugs will have a competitive business advantage.

With the industry pushing to get on the same page, equipment providers are also stepping up, offering pharma manufacturing an arsenal of tools to improve climate-focused sustainability. Recognizing the industry’s need to seamlessly integrate sustainability performance into R&D and production processes, new innovations seek to help pharma experts converge sustainability choices with other operational decisions. 

What follows is a discussion of new offerings from growing companies, purpose-built to help integrate sustainability into everyday processes.

Addressing lab consumables

Consumables, such as tubes, pipettes, filters, reagents, and well plates, are part of daily life in a pharma lab. While they provide sterile and safe options for drug development and quality testing, they also add to pharma’s costly waste problem.

Many of these consumables are made of plastic. While eliminating single-use plastics entirely from pharma labs is not a realistic solution, reducing a lab’s reliance on it can not only help the environment, but also a company’s bottom line. 

According to Virginia-based Grenova, the industry does not have to get rid of plastic — it simply needs to value it more. “Washing and reusing plastic is a more practical solution to our global plastics problem,” says Lane Major, Grenova’s president & CEO.

Grenova has developed equipment solutions that enable labs to wash contaminated plastic consumables — starting with pipette tips and microwell plates — so that they can be safely reused.

Pipette tips, which are the plastic pieces attached to the end of a pipettor, are used to transfer small amounts of liquid in laboratory studies. A typical lab will run hundreds to thousands of samples per day — which means hundreds to thousands of these tips are tossed into the trash.

But Grenova’s fully automated pipette tip washer, known as the TipNovus, enables labs to wash and reuse pipette tips an average of 10-25 times.

The equipment is compatible with most liquid handling pipette tips out-of-the-box. The National Institutes of Health (NIH), National Cancer Institute (NCI) and Center for Disease Control and Prevention (CDC) have all validated the reuse of washed pipette tips without jeopardizing equipment or precision of results. In fact, the CDC uses Grenova technology to wash its own pipette tips. 

The tech helps drastically reduce lab waste and can also be beneficial in the event of supply shortages. “During the pandemic, when labs were short on materials, our technology was able to help stretch supplies,” says Major.

But above all, with lab costs continuing to rise, new solutions must also offer profitability. According to Grenova, labs can substantially reduce consumable biohazard waste and cut operational costs through the company’s patented technology. In fact, the company says it has customers who are saving upwards of $100,000 per year in consumables by implementing Grenova solutions.

Greening drug development

Many major drugmakers, including Sanofi, GSK and Boehringer Ingelheim, have committed to the idea of ‘eco-design’ for drug products. First popularized in the late ‘90s in the context of architectural design, the eco-design concept was later applied to drug products, with the goal of integrating environmental aspects into drug product design and development.

Embedding sustainability into the R&D process for new drugs systematically addresses sustainability from the start, reducing the drug’s environmental footprint throughout all stages of the medicine’s life cycle.

Success on this front is predicated on scientists and process engineers being able to easily consider sustainability as a design criteria for the processes they are designing. At present, this involves sorting through an abundance of data manually, which makes the scenario a perfect candidate for AI.

Take another common lab consumable, such as reagents, for example. Used to trigger a chemical reaction, reagents are commonly utilized in abundance in pharma labs to ensure the integrity of analytical testing. Since many of these reagents are environmentally harmful, drug developers who are trying to develop greener drugs often resort to searching green buying guides and research studies to determine which reagents are less toxic.

“But what if you could understand the sustainability profile of pretty much any reagent or other consumable out there at scale right from the beginning?” asks Elio’s Krista. “You can then ensure with a very high probability that those decisions are creating a more sustainable drug development process.”

To that end, Elio is building an AI-powered software platform to design drug development and manufacturing processes more sustainably, starting with a consumable selection tool, helping scientists effortlessly consider more sustainable options for their consumables and the process design itself.

Elio is currently partnering with Switzerland-based CDMO and fierce environmental advocate, ten23 health, to integrate sustainability into process design for parenteral products. The partners have aligned on an ambitious end goal: To establish a new standard that prioritizes eco-friendly practices without compromising innovation, efficacy, safety or quality.

Optimizing plant floor resource utilization

The demand for drugs is ongoing, especially during extreme situations, such as shortages or pandemics. To ensure that all patients have timely access to lifesaving drugs, manufacturers are under constant pressure to produce.

On the plant floor, this means that pharma manufacturers must navigate operational demands, making sure to meet production key performance indicators (KPIs). But at the same time, manufacturers are under pressure to make measurable progress on industrial sustainability goals.

“More than ever, manufacturers need to understand the tradeoffs and synergies inherent in their decisions, especially when adding sustainability factors to existing performance metrics,” says Ben Whiteman, sustainability product manager of Proficy Software, GE Vernova.

To that end, GE Vernova, a purpose-built global energy company recently spun off from General Electric Company, has created a way to operationalize a plant’s sustainability goals, linking plant-floor actions to enterprise sustainability initiatives. The company’s new software solution, Proficy for Sustainability Insights, is designed to help industrial companies use resources more efficiently and effectively across a plant or entire enterprise, while also managing climate metrics required for regulatory compliance.

“Manufacturers need to understand their products' carbon intensity to meet climate commitments and carbon goals. The ability to attribute energy usage directly to products is a prerequisite for these calculations,” says Whiteman.

The AI-based software delivers visibility into sustainability progress with persona-based dashboards for targeted troubleshooting, which will allow operations leaders, frontline managers, and operators to manage sustainability performance and production KPIs together. The software’s AI-based analytics help continuously detect excess or unnecessary energy usage as well as water, chemicals, emissions or other waste that otherwise can go unnoticed.

An integrated future

With sustainability now a regulatory and business imperative, climate-focused sustainability has shifted from nice-to-have to need-to-have for the pharma industry. Time is running out for the pharma companies who lack strong climate-focused strategies.

“For a long time, the pharma industry could get by with not doing much, besides recently being required to report on the fact that they weren’t doing much,” says Krista. “Now, the industry needs to show progress on its corporate sustainability strategy.”

More and more, next-gen technologies are offering seamless integration of sustainability actions with the lab and production processes the pharma industry already has in place. 

 

 

 

 

 

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'