Suppliers of raw materials, lab equipment, manufacturing equipment, and other elements that go into the development and manufacture of bio/pharmaceuticals play an important role in the ecosystem that is sustainable manufacturing. Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Stefan Lutz, PhD, SVP of Research at Codexis, a provider of enzymes and enzyme technology platforms, points to organic solvents from petrochemical sources as a “dominating factor” in global warming potential (GWP). “Therefore, technologies that replace organic solvents with aqueous-based processes or enable the design of routes to have fewer organic solvent-using steps are highly desirable in terms of improving this key GWP sustainability metric,” says Lutz. “As an added benefit, enzymatic processes often enable more selective synthesis of target molecules, potentially improving yields and simplifying downstream processing.” For the manufacture of small-molecule drugs, Lutz also points to the use of biocatalysts instead of stoichiometric reagents and rare or precious metal catalysts as potential solutions to for economic or hazardous waste production issues.For large-molecule drugs, such as therapeutic RNA oligonucleotides, Lutz calls out the use of organic solvents as an environmental factor.

“Approximately 3000 kg of acetonitrile is used per kg of RNA produced giving rise to a very large carbon footprint. Enabling higher coupling efficiencies, or fragment-based syntheses, will give higher purity, full-length products that could require less or even no further purification, which is a significant contributor to overall solvent use.”

Codexis has focused on sustainability since the company was founded in 2002, and its enzymatic solutions for API synthesis, asserts Lutz, create higher yields with reduced energy use and less waste. Oligonucleotide manufacturing, for example, uses traditional chemical processes, according to Lutz, that create hazardous reagents and chemical waste and are energy intensive. “By contrast, biocatalytic processes using enzymes generally require milder conditions, utilize renewable resources, and generate less hazardous waste,” he explains.

“Codexis is currently launching its first-in-class Enzyme Catalyzed Oligonucleotide (ECO) Synthesis manufacturing platform to provide a highly versatile and effective tool box for production of therapeutic RNA oligonucleotides. The ECO Synthesis platform addresses critical sustainability challenges of traditional manufacturing methods by eliminating the reliance on hazardous chemicals and significantly decreasing the use of acetonitrile,” Lutz says.

Ecolab—which provides contamination control strategies and solutions, water management programs, and resins for downstream purification—uses greener chemistry principles, material and energy sourcing, and packaging initiatives, according to Christine Yore, vice president, Enterprise Corporate Accounts, Ecolab Global Life Sciences. The sustainable manufacture of biopharmaceuticals is challenged by high water consumption, refrigeration energy demands, and chemical and plastic waste generation, according to Yore. Closed-loops systems and water recycling are key to combat these challenges. The company’s Water for Climate program offers a way for companies to optimize water use across operations, therefore reducing water consumption and minimizing the impact on the environment. “We are also seeing that Digital technology is also playing a key role in sustainability initiatives,” says Yore. “Our Ecolab 3D technology provides key insights to our customers by tracking and monitoring water quality and water flow.” Yore also points to the company’s ion-exchange resin and jetting technologies and its cleaning, disinfection, and decontamination products that help improve operations while reducing environmental impacts. Ecolab has committed to sourcing enough clean electricity via a wind farm to power all of its European operations by 2030. Additionally, in 2023, responsible packaging practices at its facilities avoided 14.5 million pounds of virgin plastic use.”

Verdot, which supplies purification systems for the manufacture of biopharmaceuticals and gene therapies, has been proactively anticipating the sustainability requirements of the companies that use their systems by embedding sustainability into their operations, according to Charles Ruban, president and CEO, Verdot. As part of its sustainability strategy, the company launched carbon compensation initiatives in 2025.

“We have achieved one of the lowest carbon footprints, averaging 100 tons equivalent carbon of equivalent carbon per billion euro in revenue,” says Ruban. “And we’ve done that through eco design, you know, really optimizing the material usage of our products and really selecting appropriately the sustainable supplier that we wanted to work with. … [we are] designing energy efficient equipment that [optimize] material use, and we’re partnering with suppliers committed to systemic sustainability, so our carbon neutral initiative reflects the commitment of overcoming those models while enabling compliance to globally reduce their environmental footprint.”

Pharmaceutical Technology®/Pharmaceutical Technology® Europe/BioPharm International

®
eBook: Bio/Pharma Outsourcing Innovation 2025
February 2025
Pages: 20

When referring to this article, please cite it as Haigney, S. Supplying Sustainably. 

Pharmaceutical Technology Bio/Pharma Outsourcing Innovation

Articles

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Supplying Sustainably

The manufacture of pharmaceuticals involves active chemicals and other materials that may impact the environment. The latter half of the 20th century saw a surge in a movement to reduce climate change that continued into the 2000s. In 2015, the Paris Agreement put forth principles to keep global warming under 2 oC by 2050 (1). In 2019, the European Union introduced the European Green deal that committed Europe to become climate neutral by 2050 (1). In 2014, according to IQVIA, the healthcare industry contributed to 4.4% of the world’s carbon footprint (1). In response to these and other initiatives, the pharmaceutical industry has been working toward more sustainable manufacturing practices.

The push toward sustainability in pharmaceutical manufacturing also is seen in the increased requirements put on contract development and manufacturing organizations (CDMOs) by sponsor companies to follow sustainability practices, as contract organizations play a significant role in the development and manufacture of drugs.

“As significant third-party suppliers, CDMOs play a major contributing role in their sponsors’ overall emissions,” says Niall Harkin, executive director of Almac Group. “These requirements are a factor in negotiating partnerships as sponsors increasingly request evidence of sustainable or green manufacturing, and documenting these is now the norm on any new RFPs [request for proposals].”

“When we’re negotiating and contracting with our partners, they’re wanting to work with companies who do have ESG [environmental, social, and governance] sustainability policies in place,” says Andy Burns, vice president, MDI (Metered Dosed Inhaler) Business Development at Kindeva. Pharma companies that are more established have entrenched sustainability procedures, according to Burns, and those companies often require contract manufacturing and development organizations to follow those procedures before signing a contract.

According to Rajendra Kumar Sahu, chief executive officer of Navin Molecular, standards required by sponsor companies may include EcoVadis certification and a minimum requirement of a bronze medal at the CDMO’s last assessment. EcoVadis, founded in 2007, provides business sustainability ratings of more than 150,000 companies (2).

Sponsors may also require science-based targets to reduce carbon emissions and the reporting of scope 1 and 2 carbon emissions. “Such importance is placed on these [criteria]; customers are beginning to refuse to work with suppliers that do not meet at least one of these standards, and there are a number of companies making it clear that suppliers will be expected to be able to meet all three requirements/standards in the near future,” stresses Sahu.

“We used to see only Big Pharma or large generic drug companies having specific sustainability requirements. But now a lot of small to mid-sized biotech companies are talking to us and evaluating us on our sustainability related practices,” says Saharsh Davuluri, vice-chairman and managing director, Neuland Laboratories. “One of our largest generic customers has required us to apply for the SBTi [Science Based Targets initiative] validation, which is something that we are seeing other companies follow as well. On the innovator side, we’re seeing some of the large innovators enquire about our EcoVadis rating, beyond the standard frameworks of assessments that are available.”

®
eBook: Bio/Pharma Outsourcing Innovation 2025
February 2025
Pages: 12–20

When referring to this article, please cite it as Haigney, S. Working Together to Improve the Environment. 

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

Working Together to Improve the Environment

Next-generation biotherapeutics pose challenges to the development of manufacturing processes and analytical characterization because of their complexity and, in some cases, novelty. From cell and gene therapies (CGTs) and new vaccines to antibody-drug conjugates (ADCs), successful development and commercialization of these next-generation therapies may hinge on partnerships with service providers that offer specific focus, expertise, and technological experience. At certain points in the discovery and development process, developers—especially smaller firms—come to realize the unmet needs that prompt them to seek an outsourcing provider and/or partnership.The first order of business would be to bring in a partner with the correct expertise and technology to tackle the challenges of bringing a complex biotherapeutic to market. 

Bringing next-generation therapies to market brings up multiple challenges, according to Monika Paule, CEO, Caszyme. These challenges range from scientific and technical hurdles to regulatory and societal barriers. “One of the major obstacles is the social perception and acceptance of novel technologies such as CRISPR [clustered regularly interspaced short palindromic repeats]. Addressing public concerns, providing accurate information, and engaging in meaningful dialogue about the benefits, risks, and ethical considerations of these technologies are crucial,” Paule says.

Ali Pashazadeh, CEO, Treehill Partners, a transaction and drug development advisory firm focused on the biotech industry, points to the fact that the biopharmaceutical industry is currently experiencing its fourth year of financial drought, which has been one of the biggest challenges lately to bringing next-generation therapies to market. “Whilst next-generation technologies are incredibly exciting in their potential, these really require, for the first time, excellence in drug development to be combined with excellence in manufacturing,” Pashazadeh says.

Speaking specifically on nucleic acid-based therapies, Bernard Sagaert, CEO of etherna, emphasizes that the challenges are still big, even after the success of the COVID-19 vaccines. The challenges on the RNA front are tied in with RNA quality, where sometimes an inferior quality of RNA is used, which always leads to project failure in discovery or preclinical stages, cost of goods, or duration of expression, he explains. “On the delivery side, targeted expression and off-target expression reduction, balancing immune expression (regulate up or down, or be immune-neutral), and stability are the main challenges. All of these challenges can be different based on the therapeutic area where the products need to be used, whether it is in prophylactic or therapeutic vaccines, autoimmune diseases, gene editing, oncology, protein replacement, etc.,” Sagaert says.

Meanwhile, other challenges include technical and regulatory complexities, such as optimizing gene-editing precision and efficiency, ensuring scalable and cost-effective manufacturing, navigating complex regulatory requirements, and addressing safety and ethical considerations. “Overcoming these hurdles requires broad scientific expertise, strong analytical capabilities, and strategic collaborations among key ‘players’ to accelerate development while minimizing risks,” says Paule.

For the most part, it is the complexity of manufacturing involved in next-generation biotherapies that drives outsourcing in this sector. “These therapies require specialized expertise in areas such as gene and cell therapy production, advanced analytics, and regulatory compliance—expertise that many biopharma companies do not have in-house. Of course, everyone would love to do everything in-house, but the amount of initial investment needed, the need for speed in development, cost efficiency, and enhanced scalability are the main factors driving outsourcing,” says Paule.

“A certain level of complexity multiplies directly in line with” the scale of manufacturing capacity,” adds Jason Jones, global business development lead, Cellular Origins. Jones explains that if processes are complex, variable, and expensive when manufacturing 1000 doses of a next-generation therapy, then these processes will be 100x more complex, variable, and expensive if they are continued to be produced the same way as production scales up 100x.

When referring to this article, please cite it as Mirasol, F. Outsourcing Next-Gen Therapies Relies on Expertise and Technology. 

Development

The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.

Outsourcing Next-Gen Therapies Relies on Expertise and Technology

The market research and consulting firm DelveInsight predicts that a global contract development and manufacturing organization (CDMO) market already valued at more than $100 billion could potentially grow by almost half that amount, to an eventual total value of nearly $144 billion, over the second half of the 2020s.

That expansion across the market, which represents a theoretical compound annual growth rate of 6.5%, not only reflects the rise in some serious diseases, various cancers among them, but also the increasing popularity of outsourcing in the drug development process—which, DelveInsight said, comes with certain benefits in cost savings.

The firm was even retained by an unnamed “large pharma client,” looking to improve its API and finished dosage development, to produce a one-off report with the objective of benchmarking top CDMO candidates for outsourcing its projects, analyzing the CDMOs’ R&D, manufacturing, and commercializing capabilities.

Such attention to and emphasis on this research underlines the importance the bio/pharma industry is currently investing in its outsourcing decisions, and as the CDMO market continues to grow, the details of those decisions figure to get more and more precise.

To that end, when CPHI shared its top outsourcing trends for CDMOs across the globe for 2024, several key themes emerged. Chief among these were more careful consideration of geographic diversification and its implications, end-to-end or “one-stop-shop” organizations being able to improve efficiency and scalability, market shifts increasingly driven by merger and acquisition (M&A) activity, and equal responsibility between the drugmaker and the CDMO/contract research organization (CRO) engaged in a partnership—also, to a certain extent, similarly shared risk management responsibility between CDMO/CRO and customer.

Increasingly, the responsibilities referenced in seeking these potential partnerships are centered on sustainability. 

® conducted a series of interviews in January 2025 that explored this aspect, 

perhaps best encapsulated by Saharsh Davuluri,

 vice chairman and managing director for Neuland Laboratories.

“Sponsors are increasingly requiring sustainable or green manufacturing practices when negotiating for partnerships with Neuland,” Davuluri said in the interview. “I think this trend is also kind of aligned with the broader industry shift toward sustainability … we are seeing that a lot of these companies are having their own approach ... or their own frameworks in what they would like to measure their partners with. This is not just about Europe versus [the United States], but also within a particular geography, every company has a different approach.”

As the 2025 market finds its footing, we present a non-exhaustive list of partnerships announced, developed, or forged so far in the year to date, representing companies around the world offering a wide variety of specializations. With this list summarizing only a fraction of the collaborations that have progressed in just mere weeks’ time so far in 2025, there will be plenty to watch for in the months ahead.

When referring to this article, please cite it as Lavery, P. Savings and Sustainability Sought by Pharma Partners. 

With 2025 now in full swing, this article presents a review of the latest developments in outsourcing services, new facilities, and M&A activity thus far this year.

Bio/Pharma Outsourcing Innovation eBook, February 2025

Supplying Sustainably

Working Together to Improve the Environment

Outsourcing Next-Gen Therapies Relies on Expertise and Technology

Savings and Sustainability Sought by Pharma Partners