Susan Haigney

Environmental technology concept. Sustainable development goals. SDGs.

| Image Credit: ©metamorworks - stock.adobe.com

Pharmaceutical companies are forging sustainability initiatives that include investments in renewables, refurbishing facilities to net zero, and committing to a greener industry.

In addition, regulators and industry organizations such as the World Health Organization (WHO) are calling for more sustainable manufacturing practices in the pharma industry.

“Addressing the environmental impact of healthcare products is no longer optional—it is imperative,” said Yukiko Nakatani, MD, PhD, assistant director-general for access to medicines and health products at WHO. “The transformation of regulatory practices will be pivotal in shaping a pharmaceutical industry that meets today’s health needs without compromising the planet’s future.”

As the shift to sustainability becomes a core metric of success alongside speed and quality, companies are locking in environmental efficiencies during the early development phase, ensuring that program move to manufacturing with the smallest possible footprint.

 spoke with Andrew Moreo, head of process development and operations management at Andelyn Biosciences; Rahul Mittal, head of strategy & innovation at Dr. Reddy’s Laboratories; and Andrew Whitley, PhD, vice-president of global business development, life science field officer, at HORIBA; David Butler, chief technology officer, Hongene; and SreeKrishna Chopperla, senior vice president, HSE, Sai Life Sciences, about the strategies pharma companies are creating to move toward more sustainable manufacturing.

What specific changes has your company made in your drug manufacturing practices to improve sustainability?

Sustainability in manufacturing is not an afterthought; it is a design choice made at the bench. At Andelyn, we recognize that the most significant environmental impact of a drug is locked in during the development phase. To address this, we utilize optimization-by-design. This methodology uses advanced data analytics and design of experiments to identify the most efficient process parameters before we ever step into a clean room. By refining the process early in process development, we ensure that when a program moves to good manufacturing practice, it does so with the smallest possible footprint of raw materials and energy.

Dr. Reddy’s has made targeted, measurable changes in its manufacturing practices to strengthen sustainability. The company is transitioning its sites to 100% renewable power by 2030 and has already reached 60% progress toward carbon‑neutral Scope 1 and 2 operations. It has also become a water‑positive manufacturer, consistently replenishing more water than it consumes. Waste systems have been redesigned so that 99% of hazardous waste is co‑processed or recycled, significantly reducing landfill dependence. Cold chain packaging has been optimized, with over 90% of cold boxes reused across distribution points. These efforts align with global best practices, and the company’s recent earnings updates indicate that energy efficiency and operational discipline also support stronger margins.

Our focus has been on systematically redesigning processes using green chemistry principles and technology-driven innovation to minimize hazardous inputs, optimize solvent use, and improve water and energy efficiency. Across programs, we have strengthened solvent circularity, enhanced mass efficiency, and reduced waste through process innovation supported by digital monitoring. In parallel, we are deploying advanced manufacturing and green engineering solutions to structurally embed resource efficiency into our manufacturing platforms.

 We’ve focused on two levers—process design and site operations— to improve stability. On the process side, we’re advancing chemoenzymatic ligation for oligonucleotides to improve yield and cut solvent and purification burden versus traditional solid phase synthesis. On the operations side, we’ve added renewable energy elements (e.g., solar-powered exterior lighting), electrified on-site logistics (electric vehicles), and invested in solvent recycling. We also track progress through third-party ESG assessment (EcoVadis).

Which area/process of drug manufacturing impacts sustainability efforts the most?

The largest sustainability impact comes from API and chemical‑synthesis operations, which drive the bulk of energy consumption and emissions. This is why manufacturers prioritize decarbonization and report steady progress toward carbon‑neutral operations.

These steps also require significant water for purification and cleaning, making water‑stewardship programs essential, including recycling loops that support water‑positive outcomes. Hazardous waste generation is another major factor; companies now report over 99% diversion of such waste to co‑processing and recycling at scale. In contrast, packaging and logistics have lower environmental intensity, though cold chain reuse helps reduce secondary waste.

The greatest sustainability impact is determined at the process design stage. Reaction pathways and downstream isolation steps—particularly crystallization and filtration—largely define solvent intensity, energy consumption, water usage, and waste generation. When these elements are optimized early, companies can apply green chemistry principles and technology-enabled process enhancements to significantly reduce environmental burden and operational variability. In our view, sustainability is fundamentally a chemistry and engineering decision made at the core of process development.

 In nucleic acid manufacturing, sustainability is often assessed using process mass intensity (PMI), which is mainly driven by solvent and reagent consumption in synthesis and purification. Traditional solid-phase oligonucleotide synthesis is highly solvent-intensive and generates substantial chemical waste which drives PMI higher. We’re prioritizing next-generation technologies that employ biocatalysis to improve yields and reduce PMI and energy consumption while also lowering cost.

In viral vector manufacturing, inefficiency is the primary driver of waste. The area where we can create the greatest impact is within the underlying power of a manufacturing platform, which is why we focus so heavily on our AAV Curator Platform. This allows us to leverage standardization of materials, equipment, and systems, with flexibility to enable us to achieve higher yields and better full-to-empty capsid ratios from the start. By significantly increasing the usable product per batch, we effectively reduce the number of manufacturing runs required to meet the clinical goal. In the world of advanced therapies, yield is the ultimate sustainability lever because higher productivity directly translates to fewer consumables and a smaller carbon footprint per dose.

How can pharma manufacturers improve their manufacturing process to ensure better sustainability?

 As I have already emphasizsed improvement begins with designing processes differently—not merely operating them more efficiently. This involves prioritizing green chemistry, improved atom economy, circular resource use, and technology-enabled optimization from the outset. Transitioning from traditional batch manufacturing to continuous processing, and adopting process intensification and green manufacturing technologies, can significantly reduce variability, waste, and energy consumption. Most importantly, sustainability must be embedded during early development, where decisions have the greatest long-term environmental and economic impact.

A major opportunity for improvement lies in harmonizing global regulations. Having a single source of regulatory standards across regions would enable smoother logistical transitions for vendor-supplied materials, manufacturing, and final product shipment. When requirements are aligned globally, manufacturers can avoid redundant systems, duplicate testing, and unnecessary supply chain workarounds that add cost, complexity, and waste.

At the same time, facility design plays a critical role. Purpose-built manufacturing facilities, designed with efficiency from the outset, offer a significant sustainability advantage over retrofitted sites. This is why many organizations find that partnering with a CDMO [contract development and manufacturing organization] is a more sustainable path than building or managing in-house production in less optimized environments. An intentionally built-for-purpose facility allows manufacturers to right-size utilities, optimize material flows, and incorporate energy-efficient systems to reduce waste throughout the facility’s life cycle. Sustainability is not just about scale but about intentional design decisions that enable large, complex operations to run more efficiently and consistently.

 Manufacturers can improve sustainability by expanding renewable‑energy sourcing and carbon‑neutral direct operations. Demand forecasting methodologies help in batch processing. AI tools are assisting companies with a shorter path to drug development and reducing wastage of chemical solvents [and] intermediaries and saving electricity.

Water efficiency must improve through advanced recycling, membrane filtration, and real‑time monitoring so plants achieve water‑positive performance. Waste reduction requires stronger solvent‑recovery systems and partnerships that route nearly all hazardous waste to co‑processing, a benchmark some companies already meet. Digital tools such as predictive maintenance and automated analytics improve yield and reduce batch failures, contributing to better margins.Reusable cold chain packaging and lighter materials further reduce environmental load. Sustainability and efficiency become mutually reinforcing when these measures scale.

Replacing or complementing chromatography with optical spectroscopy will allow for less reliance on solvents. Spectroscopy generally does not require solvents, and therefore, there are no chemical waste products. The added upside here is that this also means significantly less cost of ownership. Everybody wins. As spectroscopy is typically much faster than chromatography and uses less energy, there is also a significant reduction in power required to obtain the required information.

 It’s important to measure consistently and set clear targets. Track PMI, energy usage, waste recycling rates, and Scope 1–3 emissions, then prioritize work based on the biggest drivers. Practical steps include reducing solvent-intensive unit operations, adding solvent recovery, and choosing higher-yield routes that use biocatalysis to reduce rework and purification burden. Stronger quality systems can also help by reducing deviations and repeat batches. Finally, simplify supply chains where possible because fewer handoffs and less transportation generally mean a lower footprint and better control.

How do you see sustainability impacting the industry in the future?

In many European countries, a reduction in carbon footprint, minimal waste, and environmentally safe elimination of any waste are already mandated and regulated. The push for improvements will only increase. Meeting these sustainability requirements will be challenging and could be very expensive. The use of optical spectroscopy, as discussed, will help pharma support these requirements.

 Our interactions with pharma indicate that sustainability is increasingly a partner-selection criterion, not just a reporting topic. Developers are asking for quantified metrics such as PMI, emissions, and waste, and they expect credible improvement plans aligned with recognized standards. Over time, processes and technologies will shift toward platforms that scale with lower PMI and stronger supply reliability. We believe the winners will be manufacturers that can prove sustainability while maintaining or improving supply reliability and cost.

There is no one-size-fits-all solution to the sustainability challenges of drug manufacturing. Instead, we must approach this challenge from all sides simultaneously by integrating better science through optimization-by-design, more efficient platforms, and smarter facility management. As the industry matures, sustainability will become a core metric of success, alongside speed and quality. We will not find a single silver bullet for sustainability. Rather, we will find success through the silver buck-shot of a thousand small, intentional efficiencies across the entire manufacturing lifecycle.

Sustainability, while being critical in conversations right now, is expected to be a core competitive requirement and be featured within strategy discussions and earnings reports.

Companies already commit to carbon neutrality, full renewable‑energy transitions, and water‑positive operations, signaling that environmental performance will shape investment, procurement, and regulatory expectations.

Annual sustainability disclosures supported by independent assurance will become standard, reinforcing transparency. Operational efficiency and sustainability will converge, since earnings commentary increasingly connects energy management and manufacturing discipline with improved margins. Supply chains will be redesigned around resilience, renewable inputs, and lower Scope 3 emissions. Regulations will tighten, and customers will prefer manufacturers with verifiable sustainability records. Over time, sustainability will define how medicines are made, how risks are managed, and how companies differentiate in global markets.

Sustainability is evolving into both a strategic differentiator and an industry baseline. Customers are increasingly evaluating environmental performance alongside cost and timelines, including process efficiency, resource circularity, and alignment with green chemistry principles. In the coming years, manufacturing platforms will be designed for resilience, efficiency, and a reduced environmental footprint from the ground up. Organizations that integrate green chemistry with resource-conscious engineering, supported by innovation and digitalization, will be best positioned to meet emerging regulatory expectations and market demand.

Sustainability in the pharmaceutical industry. Association of the British Pharmaceutical Industry

 Accessed February 17, 2026. https://www.abpi.org.uk/reputation/sustainability-in-the-pharmaceutical-industry/

WHO calls for transformative action towards a greener future in pharmaceutical manufacturing and distribution. World Health Organization. December 23, 2024. Accessed February 17, 2026https://www.who.int/news/item/23-12-2024-who-calls-for-transformative-action-towards-a-greener-future-in-pharmaceutical-manufacturing-and-distribution

Articles

Sustainable pharmaceutical manufacturing is increasingly driven by regulatory pressure, WHO advocacy, and corporate commitments to renewables, net-zero facilities, and quantified ESG performance. The largest environmental burdens are frequently fixed during early process and platform design, making optimization-by-design, green chemistry, and yield improvements critical levers. High-impact hotspots include API synthesis, solvent-intensive purification, and hazardous-waste generation; leading programs emphasize solvent circularity, water-positive operations, and near-total hazardous-waste diversion. Emerging enablers include biocatalysis, continuous processing, digital monitoring, and solvent-free analytical approaches.

Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.

Creating Sustainable Operational Excellence in Pharma Manufacturing

PharmTech Weekly Roundup–March 13, 2026

Welcome back to the PharmTech Weekly Roundup! I’m Susan Haigney, lead editor of PharmTech.

This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic shift toward complex, patient-centric modalities. Across recent developments, we see a clear industry theme: the integration of real-time data and predictive tools—from the FDA’s new adverse event surveillance systems to advanced filling platforms—is being leveraged to reduce manufacturing risks and streamline the path from clinical development to commercial supply. Simultaneously, leadership transitions at FDA could impact long-term regulatory consistency and submission strategies.

FDA Commissioner Marty Makary announced that the director of the Center for Biologics Evaluation and Research, CBER, Dr. Vinay Prasad, will be exiting the agency in April. 

This is Prasad’s second resignation from the agency. He previously left after public criticism but was then reinstated. These frequent leadership changes at FDA may create a volatile regulatory environment that could lead to the reassessment of established submission strategies and clinical evidence expectations.

 was launched by FDA this week. It is a unified platform that consolidates seven fragmented databases into a single dashboard providing manufacturers with real-time access to population-level safety signals. Historical adverse event data will be migrated to the new system, which will contain real-time adverse event reports for all FDA-regulated products by the end of May 2026.

 for an ultra-rare genetic folate deficiency establishes a significant precedent for using real-world and mechanistic evidence to clear the regulatory bar when randomized clinical trials are impractical.

European Commission has approved a 2 mg/kg every-four-weeks dosing regimen for Elfabrio

, offering a significant reduction in cumulative treatment burden for stable adults with Fabry disease.

 have entered a licensing agreement to expand access to cost-effective biosimilars in Latin America by pairing local market expertise with established biologics manufacturing capabilities.

At INTERPHEX this year in New York City, 

Groninger will be debuting a formalized "Lifecycle Solutions" service structure 

and a high-throughput ready-to-use filling platform designed to handle syringes, vials, and cartridges on a single configuration to improve production continuity,. The show is taking place at the Javits Center from April 21 through 23.

, which is happening May 20 through May 22, announced it will host 320 sessions focusing on manufacturing excellence, digital transformation, and the use of predictive tools to reduce technical-transfer risks and accelerate launch readiness.

Check out PharmTech.com for some of our latest technical articles. Contributing editor Cynthia Challener interviewed Tim Heffernan, PhD, vice president and head of the Therapeutics Discovery Division at The University of Texas MD Anderson Cancer Center about 

. The oncology sector is rapidly moving toward precision-driven, complex modalities such as next-generation antibody-drug conjugates, radioligand therapies, and multispecific antibodies to enhance tumor selectivity and overcome the immunosuppressive microenvironment.

A peer-reviewed study by authors from STERIS

 demonstrates that using Raman spectroscopy for identification and a specific detergent additive can effectively remove stubborn Type III magnetite rouge from stainless steel equipment without the need for costly mechanical polishing.

These updates highlight an industry that is becoming more technologically sophisticated while simultaneously managing complex regulatory and global supply chain shifts. Staying aligned with these trends is essential for maintaining compliance and operational efficiency. Visit PharmTech.com to read more about this week’s headlines.

Videos

This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic shift toward complex, patient-centric modalities. 

Two vials | Image Credit: ©Anton Prado PHOTO -stock.adobe.com

On March 10, 2026, SteinCares, a health care company in Latin America, announced it has entered into a licensing agreement with biopharmaceutical company Shilpa Biologicals Pvt. Ltd.to commercialize biosimilars in Latin America.

 SteinCares will hold the rights to register, commercialize, and distribute the biosimilars across the region, and Shilpa will develop the products and provide long-term commercial manufacturing.

“We are excited to partner with Shilpa Biologicals to bring this biosimilar to Latin America,” said Mitchell Waserstein, CEO of SteinCares, in the press release. “This agreement reinforces our leadership in biosimilars and our role as a strategic partner for global biopharmaceutical companies seeking to enter Latin America’s complex healthcare markets. By combining Shilpa’s proven capabilities in biologics development and manufacturing with our integrated regional platform and deep market expertise, we are creating scalable healthcare opportunities and expanding access to innovative, cost-effective treatments across the region.”

“SteinCares is a trusted partner in Latin America with proven expertise in the registration and commercialization of specialty therapies,” said Dr. Sridevi Khambhampaty, CEO of Shilpa Biologicals, in the release.

 “Through this licensing agreement, we are entering Latin America and aim to broaden patient access to safe treatments across the region. We believe this collaboration will create meaningful value for patients, healthcare systems, and our organizations as we expand our biosimilars footprint in Latin America. This collaboration reinforces our commitment to scalable, long-term global licensing partnerships and creates a strong platform for future collaborations across key international markets and our growing biosimilars portfolio.”

How Is Shilpa Biologicals Expanding Its Reach?

Shilpa Biologicals has traditionally focused on biosimilars development; however, Dr. Khambhampaty spoke with 

® in November 2025 about the company’s plans to expand into novel therapies and global innovation, which hints at the move into Latin America and strategic partnerships.

“It's an interesting time with the outsourcing partnerships and evolving biotech and CDMO [contract development and manufacturing organization] space. We have actually started doing several innovative partnerships at Shilpa,” Dr. Khambhampaty stated in the interview.

 “We are looking at equity-based partnerships, also partnerships where we are developing the product as a co-development partner with the startup that has invented or discovered the product, as well as a service-based model wherein we pitch in a part of the service that the company, that's the innovative company, or the discovery company, wants to outsource. So, we've kept a very flexible model.”

Dr. Khambhampaty also spoke about innovation in India and how increased government funding is expanding development of complex modalities, such as antibody drug conjugates (ADCs).

“I think ADCs have made a sort of come back with several ADCs being in the clinical space right now. ADCs [are] a very specialized area, and with not everybody having the capability to make the antibody, make the linker payload, as well as do the conjugation,” Dr. Khambhampaty said. “We are stepping into this niche space by creating our antibody conjugation suit and leveraging expertise from the chemistry side of the organization to synthesize the payloads and linkers. Now I think we can bring it all together to simplify the ADC supply chain.”

SteinCares. SteinCares and Shilpa Biologicals strike into licensing agreement to expand access to biosimilars across Latin America. Press release. March 10, 2026.

Mirasol F. How India’s biotech ecosystem is shifting toward innovation and global partnerships. 

https://www.biopharminternational.com/view/how-india-s-biotech-ecosystem-is-shifting-toward-innovation-and-global-partnerships

SteinCares and Shilpa Biologicals established a Latin America biosimilars licensing collaboration in which SteinCares will lead regional registration, commercialization, and distribution while Shilpa handles development and long-term manufacturing. The partnership positions SteinCares as an access-focused platform for navigating heterogeneous reimbursement and regulatory environments, and extends Shilpa’s geographic footprint through scalable licensing. Shilpa’s broader strategy includes flexible outsourcing and co-development models, alongside expansion beyond biosimilars into complex modalities, including antibody-drug conjugates enabled by emerging Indian innovation capacity.

The two companies have entered into a licensing agreement to commercialize biosimilars in Latin America.

SteinCares and Shilpa Biologicals Collaborate on Biosimilar Access for Latin America

Alpha-galactosidase (Agalsidase) enzyme. Cause of Fabry's disease. Administered as enzyme replacement therapy. 3D rendering based on protein data bank entry 1r46. | Image Credit: ©molekuul.be -stock.adobe.com

Chiesi Global Rare Diseases and biopharma company, Protalix BioTherapeutics, announced on March 9, 2026 that the European Commission (EC) has approved a 2mg/kg every-4-weeks dosing regimen for Elfabrio (pegunigalsidase alfa) in adults with Fabry disease who are stable with an enzyme replacement therapy (ERT).

 Elfabrio was approved by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in February 2023.

 The EC approval of the new dosing regimen gives Protalix a regulatory milestone payment of $25 million from Chiesi.

 the approved dosing regimen reduces burdens on patients and the health care system by extending infusion intervals. EC based the approval on results from an open-label, switch-over study that assessed the adverse-event profile, efficacy, and pharmacokinetics of the alternative dosing regimen, as well as an ongoing open-label extension study.

“The European Commission approval for 2mg/kg body weight E4W dosing regimen for pegunigalsidase alfa represents a meaningful advancement for adults living with Fabry disease and their families,” said Giacomo Chiesi, executive vice president, Chiesi Global Rare Diseases, in the press release.

 “Because Fabry disease requires lifelong treatment, the cadence of therapy inevitably becomes part of everyday life for patients and caregivers. By introducing an option that extends the infusion interval from every two weeks to every four weeks for eligible patients on stable ERT, we are offering families greater flexibility and the possibility to ease the overall burden of treatment. Ultimately, our goal is simple but profound: to help people spend less time managing their disease and more time living their lives. This milestone reflects our commitment to innovation that goes beyond delivering therapies—by listening to and understanding the real experiences of the Fabry community.”

“In Fabry disease, long-term treatment decisions must balance disease management with the realities of lifelong therapy,” said Prof. Aleš Linhart, DrSc, FESC., in the press release.

 “The approval of pegunigalsidase alfa 2mg/kg every-4-weeks provides an additional option that may help reduce cumulative treatment burden for appropriate patients while maintaining continuity of care.”

“This approval strengthens the treatment landscape for Fabry disease across the European Union by introducing an additional dosing approach that has the potential to enhance long-term care, " said Dror Bashan, president and chief executive officer, Protalix, in the release.

 “The authorization reflects not only scientific progress, but also a commitment to optimizing care delivery in a way that supports both patients and healthcare systems.”

“For many people living with Fabry disease, treatment is a lifelong commitment that impacts nearly every aspect of daily life,” said Mary Pavlou, president, Fabry International Network (FIN), in the release.

 “This approval allows for fewer infusion visits, helping reduce the ongoing burden on patients and families, allowing them to spend more time living their lives beyond treatment.”

According to the companies, Elfabrio (pegunigalsidase alfa-iwxj), a PEGylated ERT to treat Fabry disease, “is a plant cell culture-expressed, and chemically modified stabilized recombinant version of the α—Galactosidase—A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with stable pharmacokinetic parameters. In clinical studies, Elfabrio has been observed to have an initial half-life of 78.9 ± 10.3 hours.”

The new dosing regimen is for Europe only. In the United States, the FDA-approved dosing regimen of 1-mg/kg every 2 weeks remains.

What happened to the previous requests for a 4-week dosing regimen?

In October 2025, the CHMP gave a negative opinion on a dosing regimen of 2 mg/kg body weight infused every 4 weeks for Elfabrio.

 The committee found that trial data were not sufficient to determine similar efficacy. However, in January 2026, CHMP provided a positive opinion on the dosing change after re-examining the application.

“The CHMP’s positive opinion is another testament to Protalix’ s commitment to advancing treatments for people living with Fabry disease and, together with Chiesi, we are grateful to all of the patients and investigators and their staff members who participated in our clinical trial programs," said Bashan in the press release.

 “The CHMP’s positive opinion is a powerful validation for Protalix’ s innovative pipeline and our proprietary ProCellEx manufacturing platform, built on years of rigorous research and clinical progress.”

An open-label, switch-over trial, BRIGHT (formally PB-102-F50), and an ongoing open label extension study, CLI-06657AA1-03 (formerly PB-102-F51), have a median exposure of almost 6 years. These studies evaluated pegunigalsidase alfa 2 mg/kg administered every 4 weeks with additional support from modeling and exposure-response analyses across prior trials (PB-102-F01/-F02, PB-102-F20, and PB-102-F50).

Chiesi Global Rare Diseases and Protalix BioTherapeutics announce European Commission approval of additional dosing regimen of every four 2eeks for Elfabrio® (pegunigalsidase alfa). Press release. Chiesi Global Rare Diseases. March 9, 2026. 

https://chiesirarediseases.com/media/20260309-chiesi-global-rare-diseases-and-protalix-biotherapeutics-announce-european-commission-approval-of-additional-dosing-reg

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20–23 February 2023. Press release. European Medicines Agency. February 24, 2023. 

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-february-2023

Chiesi Global Rare Diseases and Protalix BioTherapeutics acknowledge CHMP negative opinion on every four week dosing regimen of Elfabrio® (pegunigalsidase alfa) in the EU. Chiesi Global Rare Diseases. October 17, 2025. 

https://chiesirarediseases.com/media/20251016-chiesi-global-rare-diseases-and-protalix-biotherapeutics-acknowledge-chmp-negative-opinion-on-every-four-week-dosing

Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for an additional dosing regimen of every four weeks for Elfabrio® (pegunigalsidase alfa) in the EU. Press release. Protalix BioTherapeutics. January 30, 2026.

https://ir.protalix.com/news-releases/news-release-details/chiesi-global-rare-diseases-and-protalix-biotherapeutics-4

The European Commission authorized a 2 mg/kg every-4-weeks regimen for pegunigalsidase alfa in adults with Fabry disease who are stable on enzyme replacement therapy, expanding dosing flexibility across the EU. The change aims to reduce infusion frequency and associated patient and system burden, supported by open-label switch-over and extension data plus PK/exposure–response analyses. The decision follows a CHMP negative opinion in October 2025 and a subsequent positive re-examination in January 2026. A $25 million milestone payment is triggered for Protalix.

The 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa in adults with Fabry disease who are stable with an enzyme replacement therapy has been approved in Europe.

European Commission Approves Dosing Regimen for Fabry Disease Treatment

PharmTech Weekly Roundup–March 6, 2026

 Weekly Roundup! I’m Susan Haigney, lead editor of 

There were some strategic investments made by industry this week, and FDA called out misleading claims about GLP-1s. Be sure to check out the full articles on PharmTech.com.

Developments across the sector highlight a period of rapid acceleration and structural modernization. A few themes our editors saw this week include the use of AI and regulatory incentives to compress development and review timelines; a wave of capital investment aimed at bolstering regional supply chain resilience; and a move toward continuous, data-driven monitoring to replace traditional, reactive quality control measures.

GLP-1s continue to dominate the headlines. FDA initiated proactive enforcement this week by issuing 30 warning letters to telehealth sites for misleading "sameness" claims regarding unapproved compounded GLP-1 drugs. This action is the second significant enforcement wave since the agency's broad crackdown on direct-to-consumer advertising began in September 2025.

In Europe, Novo Nordisk is investing €432 million to retrofit a facility in Ireland for high-volume oral GLP-1 production, complemented by an AI-driven partnership with Vivtex to optimize intestinal absorption for oral biologics.

Norgine has committed a total of $67 million to modernize its Wales manufacturing facility, focusing on high-speed, energy-efficient processes and regional supply resilience for the UK and European markets.

In drug development news, FDA granted accelerated approval for Boehringer’s Hernexeos (zongertinib) as a first-line HER2-mutant non-small cell lung cancer treatment in just 44 days, utilizing the National Priority Voucher Program to reward manufacturing domestication and the addressing of unmet health needs.

Sartorius’ new genome-edited CHO host cell line triples productivity and reduces cell line development timelines to as little as nine weeks while maintaining the long-term genetic stability required for commercial scale-up.

This week, PharmTech also looked at how the industry is using AI and other technologies to increase efficiency.

AI is transforming the industry by cutting discovery and manufacturing cycle times by up to 40% through real-time "continuous learning loops" between physical labs and computational models.

And author Tony Cundell provided an overview on how analytical techniques are used in aseptic processing. He explains that, to reduce costly product rejections, the industry is transitioning from periodic to continuous, PAT-oriented monitoring that uses real-time sensors and multivariate statistical control to detect anomalies instantly.

These updates underscore a shift where efficiency and resilience are no longer just goals, but regulatory and competitive requirements. Staying ahead requires integrating advanced analytical tools and strategic infrastructure upgrades into the standard manufacturing lifecycle.

Developments across the sector highlight a period of rapid acceleration and structural modernization. 

palovarotene molecule, molecular structures, retinoids, 3d model, Structural Chemical Formula and Atoms with Color Coding | Image Credit: ©Сергей Шиманович -stock.adobe.com

Quotient Sciences, a contract research, development, and manufacturing organization, announced on February 26, 2026 that it is extending its commercial supply partnership with biopharmaceutical company, Ipsen.

 Under the partnership, Quotient will manufacture Sohonos (palovarotene), an FDA-approved, highly potent molecule for the treatment of fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease that impacts fewer than 1000 people worldwide. The partnership will ensure that a supply of the FOP treatment is secure.

Because of its highly potent nature, palovarotene requires specialized handling and containment. Ipsen has invested in new equipment at Quotient’s Boothwyn, PA facility for the manufacture of the product. This investment includes a pneumatic closed transfer system, for safe material transfer without impacting blend segregation, and a flexible dispensing isolator to enhance operator safety and remove special cleaning requirements.

“This significant investment in advanced containment and manufacturing technology at our Boothwyn facility underscores Quotient Sciences’ unwavering commitment to supporting patients with ultra-rare diseases,”Marlene Leuenberger, VP and General Manager, Quotient Sciences, Philadelphia, said in a press release.

 “By expanding our capabilities in handling highly potent compounds, we are not only ensuring a reliable supply of critical therapies like Sohonos (Palovarotene) for the FOP community, but also reinforcing our promise to deliver flexible, high-quality solutions for our partners with specialized needs especially for highly potent compounds.”

What other targeted medicines is Ipsen developing?

In Europe, Ipsen’s monotherapy, Ojemda (tovorafenib), was given a positive opinion by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for conditional marketing authorization.

 Ojemda (tovorafenib) is a treatment for pediatric low-grade glioma (pLGG) with harboring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after one or more prior systemic therapies, in patients 6 months of age and older. According to the company, BRAF altered pLGG causes problems with sight, speech, and neurological problems in children.

“For children diagnosed with pediatric low‑grade glioma, the journey is long and complex, with limited treatment options and no clear standard of care,” said Christelle Huguet, PhD, EVP and head of Research & Development, Ipsen, in a press release.

 “Innovating in pediatric oncology is challenging, and genuine breakthroughs are rare. The evidence supporting tovorafenib, which acts on tumor growth driven by an abnormal BRAF gene, is an important development. The positive CHMP opinion moves us closer to delivering a meaningful targeted therapy for these patients and their families.”

“Treatment options for relapsed/refractory pediatric low-grade glioma have remained limited for decades, which is why a targeted therapy like tovorafenib has the potential to transform how we manage this disease in particular the most common subtype carrying the BRAF-Fusion oncogene,” said Professor Olaf Witt, director, Translational Pediatric Oncology, Hopp Children’s Cancer Center Heidelberg, in the press release.

 “As a treating physician, I am encouraged by the prospect of introducing a new treatment option for this challenging condition in Europe.”

The CHMP opinion was based on data from a pivotal phase 2 FIREFLY-1 study. Tovorafenib was evaluated in 137 children and young adults with relapsed or refractory BRAF-altered pLGG who had received at least one prior systemic therapy. The study showed there as an overall response rate of 71%, and the median time to response was 5.4 months with an 18-month median duration of response. Tovorafenib was well tolerated, according to the study, with grade 1 or 2 treatment-related adverse events.

Quotient Sciences Extends Commercial Manufacturing Partnership for Ultra-Rare Disease Treatment. Press Release. Quotient Sciences. February 26, 2026. 

https://www.quotientsciences.com/news/quotient-sciences-extends-commercial-manufacturing-partnership-ultra-rare-disease-treatment

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma. Press Release. Ipsen. February 27, 2026. 

https://www.ipsen.com/press-release/ipsen-receives-positive-chmp-opinion-for-ojemda-for-the-treatment-as-monotherapy-of-children-with-relapsed-or-refractory-braf-altered-pediatric-low-grade-glioma-3246394/

Quotient Sciences extended its commercial supply partnership with Ipsen to manufacture palovarotene (Sohonos), an FDA-approved, highly potent therapy for fibrodysplasia ossificans progressiva, reinforcing supply security for an ultra-rare population. Ipsen funded containment and handling upgrades at Quotient’s Boothwyn, Pennsylvania site, including closed transfer and isolator technologies. Separately, Ipsen advanced its targeted oncology portfolio in Europe: tovorafenib (Ojemda) received a positive CHMP opinion for conditional approval in relapsed/refractory BRAF-altered pediatric low-grade glioma, supported by FIREFLY-1 efficacy and tolerability.

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a treatment for the ultra-rare disease, fibrodysplasia ossificans progressiva.