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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. 

Orphan Drug Report 2026 | Created with Canva

On March 13 2026, Evaluate published its 2026 Orphan Drug Report.¹ 

It recounts that rare disease drugs are on track to represent more than 21% of all prescription pharmaceutical sales by 2032, up from 15% in 2022

. That translates to over $400 billion in rare disease drug revenues out of a projected $1.9 trillion total prescription market. This trajectory carries direct implications for pipeline prioritization, capacity planning, and investment decisions.

The report draws on forecasts from Evaluate Pharma to make the case that, despite a turbulent policy environment and intense commercial competition from large-indication products, the rare disease segment has demonstrated consistent resilience.¹ "We continue to see drugs for rare diseases cement their place as major players in the overall drug market,"¹ said Andreas Hadjivasiliou, manager of Content Strategy, Evaluate, in a press release. "Their capacity to navigate a changing industry, policy, and regulatory changes while maintaining momentum is something to be noted by developers in this space and in the mainstream drug markets as well."

What Do Recent Policy Shifts Mean for Rare Disease Development?

The policy landscape has shifted in ways that materially affect the commercial calculus for rare disease programs.¹ Until 2025, only single-indication orphan drugs were exempt from price negotiations under the Inflation Reduction Act. Amendments introduced through the current administration's One Big Beautiful Bill have extended those exemptions to multi-indication drugs. Separately, the Rare Pediatric Disease Priority Review Voucher program was reauthorized in early 2026, restoring an incentive mechanism that promises accelerated review timelines for products targeting rare childhood conditions.

Despite these supportive developments, orphan drugs' share of overall prescription sales is expected to decline modestly during the next seven years.¹ The report attributes this in part to a growing commercial focus on high-volume, large-indication products, most notably obesity treatments, a trend driven by the industry's need to address an estimated $300 billion revenue gap created by approaching patent expirations. This reorientation of Big Pharma resources could affect partnering opportunities, contract manufacturing demand, and competitive dynamics in shared therapeutic platform areas.

On the pipeline and commercial front, the report identifies significant near-term concentration at the top of the market.¹ The eight highest-selling orphan drugs are each forecast to exceed $6 billion in sales by 2032, and the collective sales of today's orphan drug pipeline candidates are projected to surpass $100 billion by that year. Johnson & Johnson's Darzalex, indicated for multiple myeloma, is forecast to be the top-selling orphan drug by 2032, with the subcutaneous formulation of the product credited with effectively doubling the franchise's commercial lifespan. Johnson & Johnson is projected to lead all companies in orphan drug revenues, with nearly $31 billion in forecast sales, placing particular manufacturing and supply chain demands on the organization and its partners.

How Do Recent Law Changes Affect Orphan Drug Exclusivity and Review Times?

Two legislative changes signed into law on February 3, 2026 as part of the Consolidated Appropriations Act have added further regulatory stability to the industry.² Together, they restore and clarify incentive structures that directly affect how developers and manufacturers plan rare disease programs.

The Rare Pediatric Disease Priority Review Voucher program has been reauthorized through September 2029.² Under the program, sponsors who secure approval of a therapy for a rare pediatric disease receive a transferable voucher that reduces FDA review time for a subsequent application from 10 months to approximately 6 months. Given that these vouchers have historically sold for over $100 million, reauthorization restores a meaningful financial lever for organizations weighing investment in rare childhood conditions.

The legislation also resolved a long-running legal ambiguity around orphan drug exclusivity.² A 2021 appellate court ruling had threatened to broaden the exclusivity bar to cover an entire rare disease or condition, rather than the specific approved indication. The new law codifies the FDA's narrower interpretation, confirming that exclusivity applies to the approved use or indication within a rare disease, and does so retroactively.

Evaluate. Evaluate releases 2026 Orphan Drug Report: report reveals that FDA temperament and blockbuster drugs fall short of disrupting the ever-increasing orphan drug market. News release. March 13, 2026. Accessed March 13, 2026.

Wilson Sonsini Goodrich & Rosati. Congress reauthorizes the Rare Pediatric Disease Priority Review Voucher Program and clarifies orphan drug exclusivity. February 9, 2026. Accessed March 13, 2026. 

https://www.wsgr.com/en/insights/congress-reauthorizes-the-rare-pediatric-disease-priority-review-voucher-program-and-clarifies-orphan-drug-exclusivity.html

Articles

Rare disease therapies are projected to exceed 21% of global prescription sales by 2032, surpassing $400 billion, underscoring strategic implications for portfolio selection, manufacturing capacity, and capital allocation. Policy updates improve commercial durability: IRA price-negotiation exemptions now extend to multi-indication orphan drugs, and the Rare Pediatric Disease Priority Review Voucher program has been reauthorized. Nonetheless, orphan share may modestly soften as capital shifts toward high-volume franchises (eg, obesity) amid looming patent cliffs. Top-end concentration persists, led by J&J’s Darzalex.

Rare disease drugs are forecast to exceed $400B by 2032, driven by policy shifts and pipeline growth, despite competition from large-indication products.

Why Orphan Drugs Remain Resilient in a Shifting Market

groninger at INTERPHEX NYC 2026 | Created with Canva - Image courtesy of groninger USA

For INTERPHEX NYC, taking place April 21-23, groninger will debut a formalized service structure and put a high-throughput ready-to-use processing platform in front of industry decision-makers.¹ Its presentation will offer a focused look at where filling and closing technology is heading.

What Does a Structured Equipment Lifecycle Program Mean for Manufacturing Teams?

The show will mark the formal launch of groninger’s Lifecycle Solutions concept in North America, a service program that consolidates support across the full lifespan of filling and closing equipment, from initial commissioning through continuous optimization, modernization, and retrofit.¹ For manufacturing teams, a structured approach to equipment lifecycle management is increasingly tied to regulatory compliance and production continuity rather than being a discretionary add-on.

“Comprehensive services are no longer a nice-to-have; they are an essential part of value creation,”¹ says Christian Thieme, vice president of Sales & Marketing, groninger USA, in a press release. “Our customers expect support to begin long before an issue arises. They expect—rightly so—proximity, rapid response, and an infrastructure that operates in real time.”

The program’s launch coincides with a $14.2 million investment in a new North American headquarters facility currently under construction in Charlotte, North Carolina.¹ The expanded site will include significantly increased manufacturing, assembly, and service capabilities aimed at shortening response times for customers across the region.

“With this expansion, we’re laying the foundation the market needs now: shorter distances, direct points of contact, and on-site manufacturing that can respond within hours rather than days,”¹ says Philipp Hauser, CEO, groninger USA, in the press release.

As companies continue to shift priorities toward regional manufacturing, this kind of local infrastructure has direct implications for production scheduling, validation timelines, and the ability to respond quickly when equipment deviations occur.¹

How Is the Industry’s Shift Toward Prefilled Syringes Changing Equipment Requirements?

The show will also feature a working demonstration of the UFVN, groninger’s platform targeting the upper performance range of ready-to-use container processing.¹ Built for large production volumes, the system incorporates 100% in-process control: every container is checked inline, deviations are flagged in real time, and out-of-specification units are automatically rejected. The platform is designed to handle syringes, vials, and cartridges on a single technical configuration.

Dirk Schuster, global head of Sales, groninger’s Pharma division, noted, in the press release.¹ “We’re presenting this machine platform at the show because it demonstrates what’s possible when technology and experience converge: stable high performance across all ready-to-use formats. Today, pharmaceutical companies must be able to process syringes, vials, and cartridges on a single technical platform—safely, reproducibly, and without compromising throughput or process execution.”

Prefilled syringes are steadily displacing vials as the dominant primary packaging format, driven by patient usability requirements and growing regulatory expectations around combination product design.¹ Yet, many firms still initiate development programs around vials, often discovering mid-development that a changeover to syringes introduces significant technical and regulatory rework.

“Our customers want to see that high performance, container flexibility, and process reliability work not just on paper but in daily production,” Schuster added.

groninger’s Julian Petersen, global head of Business Development Pharma, stated, in the press release,¹ “We’re seeing that early decisions on formats and technologies are increasingly determining the speed and safety of later clinical and commercial phases. When component suppliers, contract development and manufacturing organizations, and equipment manufacturers collaborate from the start, risks can be reduced and development becomes significantly more robust.”

Petersen will be presenting at INTERPHEX NYC on a new approach to system prequalification: design-verified filling systems that have been validated on current-generation lines before a sponsor’s development program reaches them.¹ For pharmaceutical development teams, this translates to reduced interface complexity between container components and filling equipment, lower technical risk during scale-up, and a more predictable path from early clinical phases into commercial manufacturing.

What Other INTERPHEX Events Should Professionals Be Paying Attention To?

The conversations taking place at INTERPHEX NYC sit within a broader global dialogue.² 

At INTERPHEX Week Tokyo, running May 20–22 at Makuhari Messe

, 35,000 pharmaceutical and biotech professionals are expected to gather for it. Its 320-session program spans manufacturing excellence, quality and compliance, supply resilience, and digital transformation. A featured session from Boehringer Ingelheim will address how aligning development and manufacturing reduces transfer risks and accelerates launch readiness, themes that resonate directly with the format and scale-up decisions discussed at INTERPHEX NYC.

groninger. At INTERPHEX NYC, groninger to introduce new “Lifecycle Solutions” concept and showcase efficient RTU processing equipment. News release. March 12, 2026.

INTERPHEX WEEK TOKYO 2026. Japan’s largest pharma gathering publishes full 320-session programme for May 2026. Press Release; Mar 11, 202

groninger will use INTERPHEX NYC (April 21–23) to introduce its North America Lifecycle Solutions program and demonstrate the UFVN high-throughput ready-to-use (RTU) processing platform. Lifecycle Solutions formalizes end-to-end service support spanning commissioning, optimization, modernization, and retrofit, aligning equipment management with compliance and uptime imperatives. A $14.2 million Charlotte, NC headquarters expansion underpins faster regional response and local manufacturing capacity. UFVN emphasizes 100% in-process control and multi-format capability as prefilled syringes increasingly drive primary packaging strategy and scale-up risk.

groninger will present innovations in equipment lifecycle programs, RTU platform flexibility, and earlier format alignment at INTERPHEX NYC, 2026.

Groninger Brings New RTU Filling Platform and Lifecycle Services Concept to INTERPHEX NYC

FDA Announces New Adverse Event Tool | Created with Canva

On March 11, the FDA launched a unified platform for analyzing adverse event reports, replacing a fragmented infrastructure that had long-impeded effective postmarket surveillance.¹ Known as the FDA Adverse Event Monitoring System (AEMS), the system consolidates data that were previously spread across seven separate databases.

Adverse event data for drugs, biologics, vaccines, and cosmetics can now be searched and viewed through a single dashboard. "The FDA's previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,"¹ claimed FDA Commissioner Marty Makary, in a press release. Those blind spots have direct relevance for manufacturers, whose own pharmacovigilance decisions depend on the quality and accessibility of population-level safety signals from the same data pools.

The agency processed approximately 6 million adverse event reports per year under the old structure, at a combined operating cost of around $37 million annually.¹ AEMS is expected to save approximately $120 million over the next five years, a reduction in administrative overhead that signals a longer-term commitment to this infrastructure.

How Does Real-Time Reporting Change the Practical Value of This Data?

One of the most operationally significant shifts is the move from quarterly to real-time publication of adverse event reports.¹ Previously, manufacturers and researchers working with publicly available safety data were working from information that could be months out of date. Under AEMS, reports will be published as they are received, subject to the agency's obligations around individually identifiable patient and consumer information.

Transparency around adverse event reports submitted by patients, consumers, clinicians, and manufacturers is a critical component of postmarket surveillance.¹ Although these reports carry inherent limitations, they can help identify potential safety signals; patterns or clusters of adverse events that might indicate previously unknown risks. With real-time access, the lag between a signal's emergence in the reported data and its visibility to the broader scientific community is substantially reduced.

The FDA also expects the new system to reduce Freedom of Information Act requests for unreleased adverse event reports, given that the data will no longer sit in queues awaiting quarterly release.¹ For manufacturers who have historically submitted such requests to monitor competitor product safety profiles or track signal development, direct access through AEMS may render that process unnecessary.

Consolidating the FDA's adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule," said Chief AI Officer Jeremy Walsh in the press release.¹ "The team executed with perfection and delivered the biggest technical transformation in agency history."

In the coming months, a few remaining product areas not yet on the platform will be migrated into AEMS, with full coverage expected by the end of May 2026.¹ These include: medical devices, human foods, dietary supplements, and tobacco products. Enhanced data analytics tools and application programming interfaces are also planned as part of the rollout, which will expand the options available to manufacturers and researchers for systematic data querying. The legacy systems being retired include the databases previously used for drug and biologic adverse event reports, vaccine adverse event reports, and animal drug and food reports.

Why Does Manufacturer Compliance Still Matter Alongside Better Infrastructure?

The launch of AEMS arrives against a backdrop of heightened scrutiny over adverse event reporting compliance. In a letter dated March 5, the FDA criticized Novo Nordisk for "serious violations" related to reporting of possible side effects linked to semaglutide, the active ingredient in Ozempic and Wegovy — citing three unreported deaths, including one suicide. "FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product's safety profile and uphold FDA's mission to protect and promote public health," the agency wrote. The case underscores why infrastructure improvements alone are insufficient; the quality and timeliness of manufacturer submissions remain equally consequential.

U.S. Food and Drug Administration. FDA launches new adverse event look-up tool. News release. March 11, 2026. Accessed March 12, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool

​Lovelace B. FDA warns Novo Nordisk of potential unreported GLP-1 side effects. NBC News. March 10, 2026. Accessed March 12, 2026. 

https://www.nbcnews.com/health/health-news/fda-warns-novo-nordisk-glp-1-unreported-potential-side-effect-rcna262803

FDA introduced the Adverse Event Monitoring System (AEMS), unifying seven legacy safety databases into a single dashboard for drugs, biologics, vaccines, and cosmetics. The platform shifts public posting from quarterly batches to near real-time availability, shortening signal-detection latency while maintaining privacy protections. Operating costs previously ran about $37 million annually for ~6 million reports; projected savings are $120 million over five years. Additional domains—including devices, foods, supplements, and tobacco—plus APIs and analytics are planned, but accurate, timely manufacturer submissions remain pivotal.

FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers.

How FDA's New Adverse Event Tool Affects Drug Manufacturers

Interphex week Tokyo 2026 | Created with Canva - Interphex Image courtesy of RX Global

Interphex Week Tokyo 2026, scheduled for May 20-22 at Makuhari Messe in Chiba, Japan, has published its full conference schedule.¹ The conference spans 320 sessions across manufacturing; quality; chemistry, manufacturing and controls; and digital transformation.¹ Asia’s leading trade show for the pharmaceutical, biotechnology, cosmetics, and regenerative medicine industries, expects to draw around 950 exhibitors and 35,000 industry professionals across the three days. The breadth of the program presents a practical opportunity for learning with specific team priorities, for example, process development, regulatory compliance, supply chain resilience, and the integration of digital tools into production and quality systems.

The 320 sessions draw on perspectives from government agencies, global pharmaceutical manufacturers, solution providers, and academia.¹ Content spans organiser-led conferences, exhibitor seminars, and an academic forum. Some of the topics include manufacturing excellence, quality and compliance, supply resilience, and digital transformation. The mix is designed to support the translation of technical insight into operational practice.

For teams working in formulation and late-stage development, a session from Martin Maus, head of Late Oral Product Development, Boehringer Ingelheim Pharma GmbH & Co. KG, will address how solid oral dosage forms be developed in close alignment with patient needs and the capabilities of an international manufacturing network.¹ Maus will discuss how alignment between development and manufacturing reduces transfer risks, accelerates launch readiness, and enables smoother supply transitions to routine sites. The session will also cover digital and predictive tools, including hybrid mechanistic statistical models, real-time machine-learning-based process control, and discrete element method simulations.

How Is the Event Supporting International Participation?

For professionals based outside Japan or working within internationally dispersed teams, one practical development in the 2026 program is the inclusion of real-time translation support.¹ A total of 47 sessions will be supported by an AI translation tool, offering real-time text transcription and audio readout in multiple languages.

Attendance at Interphex Week Tokyo 2026 is free with advance visitor registration, which also allows delegates to secure a visitor badge and plan their agenda before arriving on site.¹ 

The full conference program is now publicly available on the Interphex week website.

What Other Pharma Conferences Should Professionals Focus On?

The appetite for large-scale pharma industry gatherings extends beyond Japan as CPHI & PMEC China 2026, taking place June 16-18 at the Shanghai New International Expo Centre.² The event expects to draw over 110,000 attendees and more than 3,600 exhibitors, making it Asia's largest pharma event by attendance. The 2026 edition will feature over 100 conferences and workshops led by more than 700 experts, covering areas from active pharmaceutical ingredients and biotech to pharmaceutical machinery and traditional Chinese medicine. As Orhan Caglayan, executive vice president of the Pharma Portfolio, Informa Markets, notes, in a press release,² "The growth of CPHI & PMEC China mirrors the extraordinary pace of innovation in China, solidifying its position as the ultimate destination for sourcing, supply chain optimisation and forging strategic partnerships."

INTERPHEX WEEK TOKYO 2026. Japan’s largest pharma gathering publishes full 320-session programme for May 2026. Press Release; Mar 11, 2026.

​ANTARA News. The largest pharma show in Asia makes its return to Shanghai this June 2026. March 11, 2026. Accessed March 11, 2026. 

https://en.antaranews.com/news/407943/the-largest-pharma-show-in-asia-makes-its-return-to-shanghai-this-june-2026

Interphex Week Tokyo 2026 (May 20-22, Makuhari Messe, Chiba) has released a 320-session agenda spanning manufacturing, quality, CMC, and digital transformation, with participation from regulators, global manufacturers, solution providers, and academia. Attendance is projected at ~950 exhibitors and 35,000 professionals across pharma, biotech, cosmetics, and regenerative medicine. Programming emphasizes operational translation of technical insights, including supply resilience and compliance. A highlighted Boehringer Ingelheim session addresses late-stage oral development alignment with global networks and predictive/digital process-control tools.

Japan's largest pharma event returns May 2026 with 320 sessions spanning manufacturing, quality, CMC, and digital transformation.

320 Sessions Confirmed for Interphex Week Tokyo 2026

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

Emily Null, MS, is a scientist with Steris Corp.

Mildred R. Bernardo is lead scientist with Steris Corp. 

Si Myra Tyson is a senior technical service associate for the Life Sciences Division of STERIS.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Stainless steel pipe fittings, clamps, and connectors arranged in industrial. Precision manufacturing, mechanical assembly, and hygienic processing systems for food and pharmaceutical industries. | Image Source: ©Artinun -stock.adobe.com

Type III or Class III rouge (magnetite) appears as a black oxide in water systems and production equipment exposed to sanitization, pasteurization, or steam sterilization conditions. Remediation of type III rouge often requires electropolishing or mechanical polishing of the stainless-steel surface, resulting in significant labour cost, safety risk to operators with confined space entry, downtime of the equipment or system, and a reduction in thickness of the stainless steel. Raman spectroscopy is a non-invasive analytical method that can quickly identify the presence of magnetite (Fe

) in rouge. Based on the identification of magnetite, a detergent additive can be combined with a formulated citric/oxalic or a phosphoric/citric acid blend to transform insoluble magnetite to a more soluble form of iron oxide. This approach to type III rouge remediation utilizing a detergent blend, spray device, and recirculating pump reduces downtime, safety risk, material loss, and overall cost of maintenance.

A common surface in production equipment and piping is 300 series stainless steel. This surface is compatible with most pharmaceutical and biopharmaceutical processes; however, certain conditions can lead to discoloration and/or rouge on the surface. Rouge is a corrosion product on or in the surface of the iron alloy. Rouge is generally classified as Type I–III or Class I–III.

 Type I rouge (migratory rouge) is an iron oxide that is loosely attached to the surface and can be wiped off the surface. The origin of this rouge is often from an upstream source. Type II rouge (in situ rouge) is difficult to wipe off and often contains underlying damage to the surface. Examples of Type II rouge include galvanic, intergranular, pitting and stress corrosion. Common acid blends, such as citric/oxalic or phosphoric/citric solutions, can be effective at removing Type I and II rouge.

 These treatments do not restore original surface roughness. Electro- or mechanical polishing may be required to correct surface damage due to Type II rouge from pitting corrosion. Type III rouge is often associated with high temperature and purity water systems. Type III rouge is challenging to remediate due to the presence of magnetite (Fe

). Magnetite removal often requires aggressive chemicals or electro- or mechanical polishing. An acid detergent with phosphonate can be used alone or in combination with a citric/oxalic or phosphoric/citric acid blend to improve the solubility of magnetite and the removal of Type III rouge.

Understanding when and which acid detergent (or detergent additive) to use in rouge remediation can be difficult. The selection of the acid detergent should consider effectiveness to remove the rouge, substrate compatibility, rinse profile, stability and shelf life, analyzability, toxicity, disposal constraints, personnel safety, toxicity, foaming characteristics, microbial effectiveness, quality of manufacture, long-term availability, quality of manufacture and overall cost.

 Raman spectroscopy can be a powerful tool in identifying the oxide compound(s) present and provide direction to successful remediation. Alternative spectroscopy and microscopy techniques may be applicable for surface characterization and corrosion monitoring, such as X-ray diffraction (XRD) and scanning electrochemical microscopy (SECM).

 Raman uses inelastic light scattering, where the incident light (from a high-intensity laser light source) transfers energy to molecular vibrations, and the scattered light collected at the detector provides structural information relating to the molecule. Each molecule/compound will have a unique spectrum. Magnetite displays a primary peak with Raman spectroscopy between 662 and 670 cm

 A secondary peak is often observed at 532 and 550 cm

. A common roadblock in successful rouge remediation is the presence of magnetite. A quick identification of magnetite in a rouge surface using Raman spectroscopy can be helpful in selecting the right chemical treatment and cleaning parameters.

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

A Raman microscope with a 532 nm laser (DXR3, Thermo Scientific) was used to analyze selected sample areas. Areas that visually exhibited the greatest amount of residue were selected and focused on using the confocal microscope prior to analysis. The samples were analyzed as is (without cleaning, modification, etc.) using the following conditions in 

After analysis of the selected sample areas, a spectral library search (Wiley Science Solutions KnowItAll Spectral Library) was performed for each Raman spectrum.

For reference and comparison throughout the following case studies, the Raman spectra of hematite (Fe

Hematite exhibits peaks at approximately 220, 290, 400, 600, and 1300 cm

Figure 2. Raman Spectrum of Magnetite (Fe

A large multinational biopharmaceutical drug manufacturer indicated that visible rouge was unable to be removed from a tank using 10% v/v citric/oxalic acid detergent at 70 to 80 

C. Citric/oxalic and phosphoric/citric acid blends are commonly recommended for rouge removal.

 The nature of the rouge was investigated using Raman spectroscopy to identify the oxide composition and determine the reason for the difficulty in the chemical removal. Raman spectroscopy is an analytical tool that can be used in the laboratory and modified for use on the manufacturing floor.



. The following swab samples of the rouge were analyzed using Raman spectroscopy (See 

TA-9620 Pre-Derouge Swab Bottom Visible Ring

TA-9640 Rouge Observation Top Spot Near Sight Glass

Figure 3. Raman Spectra of Swab Samples. Figure courtesy of the authors.

. A spectral library search (Wiley KnowItAll Spectral Library) was performed for each Raman spectrum. All the residue samples exhibited a best match to a mixture of iron oxide compounds—hematite (Fe

). A representative search result is shown in 

Figure 4. Raman Spectra of Iron Oxide Mixture Reference (Mixture of Fe

) and TA-9720 Bottom of the Tank Outlet. Figure courtesy of the authors.

. All the Raman spectra from the selected swabs were similar to each other and exhibited peaks around 200, 300, 400, 700, and 1300 cm

, which can be attributed to an iron oxide mixture of Fe

. The general recommendation based on the swab analysis by Raman spectroscopy was to increase the concentration of the citric/oxalic agent detergent to 15% v/v and add a detergent additive at 15% v/v with recirculation through a device at 60 to 80

C for 1 to 3 hours to solubilize and remove the rouge containing magnetite (Fe

A large multinational biopharmaceutical blood product drug manufacturer submitted two end caps (one smaller and one larger) for Raman spectroscopy analysis. Both end caps exhibited brown discoloration consistent with rouge (

Figure 5. Small End Cap. Figure courtesy of the authors.

Figure 6. Large End Cap. Figure courtesy of the authors.

With 10x magnification, the small end cap exhibited orange, blue and purple/brown discolored areas. Areas of each colour were selected for Raman analysis to determine if there were any differences in the Raman spectra. Representative areas of analysis for the three different colours observed on the end cap’s surface are marked by a red square in the images below (

Figure 7. Small End Cap – Orange Area (10x mag). Figure courtesy of the authors.

Figure 8. Small End Cap – Blue Area (10x mag). Figure courtesy of the authors.

Figure 9. Small End Cap – Purple/Brown Area (10x mag). Figure courtesy of the authors. 

The three different colored areas of the end cap were analyzed, and the Raman spectra were found to be comparable to each other. A comparison of the spectra is shown in 

Figure 10. Raman Spectra of Analyzed Areas of Small End Cap. Figure courtesy of the authors.

. A magnified image of the residue present on the large end cap is shown in 

. The small area marked by a red square is representative of the area selected for Raman analysis.

Figure 11. Large End Cap – Brown Area (50x mag). Figure courtesy of the authors.

. The Raman spectrum of the brown area from the large end cap is shown in 

Figure 12. Raman Spectrum of Large End Cap. Figure courtesy of the authors.

. The three Raman spectra of the small end cap and the Raman spectrum of the large end cap were comparable to each other, with peaks at approximately 660, 600, 496, 408, 292, and 223 cm

.

When a spectral library search was performed (Wiley Spectroscopy KnowItAll Spectral Library), the residue from the end caps appeared to be a mixture of hematite (Fe

). A comparison of the Raman spectra of the residue from the small and large end caps to the hematite and magnetite Raman spectra is displayed in 

Figure 13. Raman Spectra of End Caps, Magnetite, and Hematite. Figure courtesy of the authors.



The end cap spectra matched well to the hematite spectrum; however, the peak around 665 cm

 had a greater intensity than the hematite reference spectrum, suggesting the presence of magnetite, which has a high intensity peak around 665 cm

 The residue was effectively removed from stainless steel by agitated immersion using a solution of 15% v/v formulated phosphoric/citric detergent plus 15% v/v detergent additive at 80 °C for 24 hours (

Figure 14. Derouge and Passivate End Cap Samples. Figure courtesy of the authors.

A large multinational biopharmaceutical drug product manufacturer submitted pipe samples with suspected rouge for Raman spectroscopy analysis. The pipe samples exhibited a brown discoloration consistent with rouge throughout its outer surface.

. Three different areas on the pipe were analyzed using Raman spectroscopy. The spectra of the three areas were found to be comparable to each other. A comparison is shown below in 

Figure 15. Raman Spectra of Analyzed Areas of Pipe. Figure courtesy of the authors.

. A spectral library search was performed (Wiley Spectroscopy KnowItAll Spectral Library), and the Raman spectrum of the brown discoloration from the pipe had a best match to the spectrum of a mixture of hematite (Fe

). A comparison of the Raman spectrum of the hematite and magnetite mixture and the Raman spectrum of the brown residue from the pipe is shown in 

Figure 16. Raman Spectra of Iron Oxide Mixture and Brown Residue From Pipe. Figure courtesy of the authors.

 The brown discoloration was effectively removed compared to untreated controls from stainless steel by agitated immersion using a solution of 15% v/v formulated phosphoric/citric acid detergent plus 15% v/v formulated detergent additive or a 15% v/v formulated citric/oxalic acid detergent plus 15% v/v formulated detergent additive at 80 °C for 4 hours. The surface was tested with an electrical pen test kit to confirm a passive surface following treatment. Testing with 15% v/v formulated phosphoric/citric acid or the formulated citric/oxalic acid detergent at 80 °C for 24 hours was not successful in removing the discoloration shown in 

 alongside untreated controls (left side) and successfully derouged and passivated pipe samples (right side).

Figure 17. Case Study 3 Heat Exchanger Pipe Samples, Left to Right:

Sample 3, Cleaned with 15% formulated phosphoric/citric acid detergent

Sample 4, Cleaned with 15% formulated citric/oxalic acid detergent

Sample 5, Cleaned with 15% formulated phosphoric/citric acid detergent plus 15% detergent additive

Sample 6, Cleaned with 15% formulated citric/oxalic acid detergent plus 15% detergent additive

A general requirement of pharmaceutical drug manufacturers is that equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive or absorptive so as not to alter the strength, quality, integrity, identity and purity of the drug product.

 The presence of discoloration or rouge on direct and indirect product surfaces has been cited by regulatory authorities.

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