Susan Haigney

European Union Health Concept | Image Credit: ©xtock -stock.adobe.com

On Dec. 11, 2025, the European Parliament 

 that it has reached an agreement with Council negotiators to move ahead with revising the pharmaceutical policy framework in the European Union (1), following a proposal in 2023 by the 

 (EC) to revise pharmaceutical legislations to adapt to patient and industry needs to make drugs more accessible and affordable (2). The reform addresses the issues of market protection, antimicrobial resistance (AMR), market authorization, and drug availability. The Council is expected to formally adopt the agreement and Parliament is expected to endorse the agreement in 

“We need new, innovative therapies for unmet medical needs, for conditions currently without treatment, rare diseases, pediatric medicines, new antibiotics,” 

 (EPP, PL), Chair of the Committee on Public Health (SANT), said in a press release (3). “We need equal access to medicines in all Member States, without delays, as differences in access between EU Member States can now reach up to two and more years. But equally importantly, we need medicines we can afford, meaning that competition of cheaper medicines begins immediately after an agreed deadline that protects innovation. I believe that for all these purposes, we have managed to achieve a balance in the regulations of this largest reform of the EU medicines market in over 20 years.”

What does this mean for market exclusivity?

As part of the reform, there will be a regulatory data and market protection period of eight years. During this time, other companies cannot access product data. An additional year will also be granted of market protection following market authorization in which generic or biosimilar products cannot be sold.

In addition, another year of market protection will be granted for the following drug types:

medicines that contain a new active substance that fulfill “a combination of conditions on comparative clinical trials, clinical trials carried out in several member states, and the obligation to apply for market authorization within 90 days after the submission of the application for the first marketing authorization outside the Union” (1)

medicines that provide one or more new therapeutic indications that have a significant benefit compared to products already on the market.

Under the agreement, the combined regulatory protection period will have a cap of 11 years. Drugs for orphan diseases with no current treatment available would get up to 11 years of exclusivity.

“To support earlier market entry of generic and biosimilar medicinal products, the deal clarifies the scope of the ‘Bolar’ exemption (which allows manufacturers to conduct certain activities during the market protection period of the original product). Patent rights would not be infringed when necessary studies, trials and other activities are conducted for the purposes of obtaining marketing authorizations, conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications,” the press release clarifies (1).

How will antimicrobial resistance be improved?

The deal introduces a ‘transferable data exclusivity voucher’ for priority antimicrobials. This voucher will give AMR drugs a year of additional data protection for one authorized product. The extension may only be used once for the priority drug or for another authorized drug of the same or different marketing authorization holder.

Stricter requirements, such as compulsory medical prescriptions, specific information in package leaflets, and an awareness card for package leaflets that are only available online will be put into place as part of the agreement. Companies will also need to provide an antimicrobial stewardship plan and a risk evaluation for AMR as part of a mandatory environmental risk assessment.

The European Medicines Agency (EMA) will have their internal functioning simplified as part of the updated rules, with marketing authorization applications submitted electronically in a common format and drug approvals valid by default for an unlimited period. Regulatory sandboxes to allow for development and testing of innovative drugs may be set up by the EC under supervision of competent authorities.

European Parliament. Deal on Comprehensive Reform of EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation

EC. European Health Union: Commission Proposes Pharmaceuticals Reform for More Accessible, Affordable, and Innovative Medicines. Press Release. April 25, 2023. 

https://ec.europa.eu/commission/presscorner/detail/en/ip_23_1843

European Parliament. Deal on EU Pharmaceutical Package–Statements. Dec. 11, 2025. https://www.europarl.europa.eu/news/en/press-room/20251209IPR32112/deal-on-eu-pharmaceutical-package-statements

Articles

The European Parliament and Council have agreed to revise the EU pharmaceutical policy framework, aiming to enhance drug accessibility and affordability. The reform addresses market protection, antimicrobial resistance, and drug availability, with a focus on innovative therapies for unmet medical needs. Market exclusivity will be capped at 11 years, with specific provisions for orphan drugs and priority antimicrobials. The European Medicines Agency will streamline its processes, including electronic submissions and regulatory sandboxes for innovative drug development. The agreement awaits formal adoption by the Council and endorsement by Parliament.

Co-legislators in Europe have reached a provisional agreement on a new pharmaceutical policy framework to help boost competitiveness, innovation, and supply chain security.

European Parliament Revamps Pharmaceutical Policy Framework

Drug manufacturing process. Conveyor with medical tablets blisters line at modern pharmaceutical plant. Pharmacology production, medicine industry. Laboratory, factory, pharmacy. Healthcare, pharma 3D | Image Credit: ©Corona Boreal -stock.adobe.com

Contract packaging organization, Tjoapack, 

 that it is expanding its packaging services and operational footprint in the United States. A new 170,000-sq.-ft. facility will be built next to the company’s existing site in Clinton, Tenn. The new facility, scheduled to be completed in early 2027, will include a good manufacturing practice suite with packaging, labeling, cold chain, and ambient storage capabilities.

The expansion will support high-speed packaging lines for a variety of dosage forms, such as solid dosage bottles and blister packs, vials and autoinjectors for injectable products, and secondary packaging.

“This expansion marks a major step in our strategic goal to enhance our presence in the United States. As a crucial market with considerable growth opportunities, it allows us to serve our existing clients more effectively and attract new ones.” said Dexter Tjoa, CEO of Tjoapack, in a press release (1). “We’ve invested heavily in automating our core processes, not only within packaging lines but throughout our cross-company workflows with customers and material vendors. This allows us to reduce human error and enhance accuracy, speed, and flexibility, which ultimately benefits our clients.”

What other expansions has the company invested in?

 it was expanding cold chain storage services in both the US and The Netherlands for injectables and biologics (2). The company’s Etten-Leur site in The Netherlands added 84 pallet spaces, and its Clinton, Tenn. facility completed installation of two advanced packaging lines. The site added a high-speed, full automated vial packaging line with an annual processing capability of 20 million vials. Cold storage capacity was also expanded at the site with a total of 160 good manufacturing practice-compliant pallet spaces controlled at 2–8 °C.

What will Tjoapack be showcasing at Pharmapack Europe 2026?

 with be showcasing its packaging solutions at the 

 event in Paris on January 21–22 at Paris Expo Porte de Versailles. The team will be at Stand 4D118 to talk about the company’s capabilities in oral solid dosage packaging, vials and prefilled syringes, primary packaging, secondary packaging, biotech packaging, and unit dose packaging.

What are some recent innovations in pharma packaging?

® in March 2025 to discuss innovations in bio/pharmaceutical packaging, such as those that have resulted from the demand for temperature-sensitive therapies and customized packaging configurations (3).

“We've been investing heavily in expanding our cold chain capabilities, in expanding our capability and capacity to package unique configuration for injectable products, whether that is a product that comes to us in a syringe format, a vial format, or an auto injector format,” Belden said in the interview. “[We have] the ability to either automate or semi-automate, label, and then finish [to] pack those products while maintaining tight control of time [and] temperature to allow for packaging, and then getting those materials and finished goods back into cold storage. [We also serve] as a potential logistics hub for several of our clients to manage the supply complexity, then shipping those time- and temperature-sensitive medicines to the many markets around the world that our client base is serving.”

Sustainability has also been impacting the choices made for packaging materials, as companies work to meet environmental standards. 

, vice-president, Climate and Circular Economy, 

 before her presentation at CPHI Frankfurt 2025 in October about fiber-based packaging and how it can help pharmaceutical companies meet their sustainability goals (4).

“By definition, fiber-based packaging means packaging that is made of paper or paper board. Paper and paper board is made from pulp, and the typical raw material for pulp is wood,” Pohjakallio explains.

According to Pohjakallio, the wood must be sourced from sustainable sources. For example, all the wood procured by Metsä Group and Metsä Board comes from either certified forests or forests that meet the requirements of controlled origin. The procured wood is also utilized in a sustainable way, she explains. For instance, logs from the thickest part of the trees are utilized for making mechanical wood products, and wood from the thinner parts of the trees that don't qualify for timber and construction elements are used for making pulp.

Tjoapack. Tjoapack Announces Major US Expansion to Improve its Packaging and Logistics Capabilities. Press Release. Dec. 5, 2025. 

https://www.tjoapack.com/news-events/tjoapack-announces-major-us-expansion-to-improve-its-packaging-and-logistics-capabilities

Tjoapack. Tjoapack Continues to Expand Its Global Infrastructure with Strategic Investments in Injectable Packaging and Cold Chain Capabilities. Press Release. June 5, 2025.

Haigney, S. DCAT Week 2025: Packaging Innovations. 

https://www.pharmtech.com/view/dcat-week-2025-packaging-innovations

Haigney, S. CPHI Frankfurt 2025: Fiber-Based Packaging for Sustainability. 

https://www.pharmtech.com/view/cphi-frankfurt-2025-fiber-based-packaging-for-sustainability

Tjoapack is expanding its US operations with a new 170,000-sq.-ft. facility in Clinton, Tenn., set to open in 2027. This expansion will enhance packaging services, including high-speed lines for various dosage forms and cold chain capabilities. The company has also invested in cold chain storage in the US and The Netherlands. Tjoapack will showcase its packaging solutions at Pharmapack Europe 2026. Innovations in pharma packaging focus on temperature-sensitive therapies and sustainability, with fiber-based packaging emerging as a key solution for meeting environmental standards.

A new facility in Tennessee will boost high-speed pharma packaging capacity and strengthen US supply chain support.

Tjoapack’s Advanced Packaging Expansion Aims to Meet  Rising Demand

Sanner, a company that offers sustainable packaging products and contract development and manufacturing services, announced on Dec. 10, 2025 that it will be showcasing its new Tethered Cap as part of its sustainable effervescent tablet packaging portfolio at 

, which is being held from Jan. 21–22 in Paris.

Because the TE safety ring on the tethered cap stays attached, it allows for all plastic components to be recycled, which has become a priority for manufacturers of effervescent supplement tablets looking to improve sustainability of their products. The Tethered Cap also is easy to implement to existing filling processes without changeovers or interruptions.

“Supporting a functioning circular economy is very important to Sanner,” emphasized Stefan Verheyden, CEO of the Sanner Group, in a press release (1). “This applies to our products as well as our own operations. The fact that we recently achieved EcoVadis Gold status confirms that sustainable processes are firmly anchored in our corporate strategy.”

Sanner will be presenting the Tethered Cap along with its expanded global production footprint and packaging services, including its portfolio of desiccant solutions, such as the TabTecCR, for moisture- and odor-sensitive pharmaceuticals and supplements, at booth 4G46 during the event.

In addition, Verheyden and Jim Collins, president of Pharmaceutical Delivery Systems LLC, will provide insights into the impact of international trade policy on the pharmaceutical industry in their joint presentation at the event on Jan. 21, 2026, at 11 a.m.

How are sustainability efforts impacting pharma?

Early efforts in sustainability in pharma have become foundational to the industry in recent years and are a strategic focus dictated by evolving client expectations, rigorous environmental audits, and respecting planetary boundaries (2, 3). This industry shift is a response to global climate pressures—the healthcare sector contributes 4.4% of global carbon emissions—and a recognition that profitability and responsibility must converge (3–5).

At CHPI Frankfurt, Maija Pohjakallio, VP, Climate and Circular Economy, Metsä Group, discussed how fiber-based packaging can help with sustainability efforts.

“A very important question related to packaging is that by optimizing your packaging solutions, you can reduce your scope three emissions,” Pohjakallio said in 

 (3). “And regarding fiber-based packaging, there are two very important elements that actually have a big influence on the carbon footprint on the packaging. One is the share of fossil free energy utilized in the production. And the other one is material efficiency. If you use less fibers in making the packaging of same properties, of course, that means better carbon footprint.”

, which is headquartered in Germany, has manufacturing facilities across Germany, France, Hungary, China, and the United States. The company offers desiccant closures and effervescent tablet packaging, customized solutions in the areas of medical devices and diagnostics, pharmaceuticals, and consumer healthcare, and supplies its products to more than 150 countries globally and has more than 820 employees.

“Sanner has consistently expanded both its global presence in device development and its production capacities over the past two years,” explained Christian Classen, CSO of the Sanner Group, in the press release (1). “By providing the entire process—from design to verification and validation to commercial production—from a single source, customers benefit from consistent Design for Manufacturing and Assembly right from the early development phase. With the help of the expertise of our Human Factors specialists, we can also optimize usability. This integrated approach enables a seamless transition from development to industrialization and has been proven to reduce complexity, development times, and project risks."

For more coverage of Pharmapack Europe, visit 

Pharmapack 2026: Sanner launches Tethered Cap

Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma

CPHI Frankfurt 2025: Fiber-Based Packaging for Sustainability

Working Together to Improve the Environment

Sanner is set to showcase its new Tethered Cap at Pharmapack Europe, emphasizing sustainability in effervescent tablet packaging. The cap's design allows for complete recycling of plastic components, aligning with the industry's sustainability goals. Sanner's CEO highlights the company's commitment to a circular economy, supported by their EcoVadis Gold status. The company will also present its global production capabilities and desiccant solutions. Additionally, Sanner's leaders will discuss international trade policy impacts on the pharmaceutical industry. The shift towards sustainability in pharma is driven by client expectations and environmental audits.

The new Tethered Cap, which will be showcased at 2026 Pharmapack Europe, addresses the demand for sustainability with a TE safety ring that remains attached to the cap.

Sanner to Launch Tethered Cap at Pharmapack Europe 2026

medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry. | Image Credit: ©Quality Stock Arts - stock.adobe.com

Good manufacturing practices (GMPs) set by regulators in the 

(3) govern pharmaceutical manufacturing. Building and maintenance of manufacturing buildings and equipment fall 

 (4,5) and usually must comply with these rules in the form of risk-based maintenance programs.

® spoke with David Basile, VP Technical Operations, Americas, Hovione, about the regulatory requirements for GMP facilities and equipment and how often these facilities should be evaluated for potential upgrade to ensure they meet standards.

PharmTech: GMP facilities have certain regulatory requirements. What do regulators say about the maintenance of these facilities?

 Maintenance is instrumental to what we do as a CDMO (contract development and manufacturing organization). Our ability to deliver products to our customers, and ultimately to patients, is vital. We count on having our assets available when we need them. So, at a very basic level, regulators expect us to maintain our facilities at a high level of cleanliness and in a good state of repair to prevent contamination and mix ups.

Maintenance programs in our industry require documented schedules and procedures for preventative maintenance and cleaning to ensure sustained compliance. The most recent agency guidelines emphasize the use of risk-based approaches to maintenance in order to drive focus on the most critical assets that are closest to the product. At Hovione, we take a comprehensive cradle-to-grave approach to facilities management that starts with proper specification, design, and installation through retirement, using a modular, scalable process that accelerates deployment of our critical facility and equipment assets.

How often should GMP facilities be evaluated for potential refurbishing or updating in accordance with GMP regulations?

There's no set frequency in the regulations. We use a risk-based and lifecycle approach, following industry guidance and best practices. Regular GMP walk throughs and internal audits help us proactively uncover deficiencies. We also use our annual shutdown planning cycle as an opportunity to identify and prioritize these updates. Over the long term, our capital planning cycle covers more substantial, strategic facility upgrades. Other factors that can also drive this evaluation include changes in client needs or market demands or new product introductions. For example, we might have a client that has a pipeline of potent products, in which case we would evaluate the implementation of, say, air locks or isolators or misting stations in those relevant areas. At Hovione, we know it's also critical that we continually modernize our equipment and manufacturing systems to stay ahead of the curve. So, we're continuing to upgrade our facilities by investing in the latest advanced technologies and spray drying and continuous tableting platforms and expanding our capacity here in New Jersey, strengthening the reliability of our supply in the United States.

How often should equipment that is used in GMP facilities be evaluated to ensure it still meets standards?

This is usually governed by the site's validation master plan, which covers requalification or periodic assessment of GMP equipment. The time period for each type of equipment will vary based on risk assessment, but three to five years is a typical timeframe. This entails a comprehensive review of historical changes to the equipment, failure trend analysis, and CAPA [corrective and preventive actions] effectiveness to confirm that the equipment continues to meet its original performance specifications. GMP manufacturing and lab equipment also require that regular calibration be performed more frequently with critical instrumentation.

Again, we take a lifecycle approach to maintaining equipment, where the equipment master serves as a birth certificate when a machine comes in, all the way through to decommissioning. This is a fundamental part of good asset management.

FDA. Current Good Manufacturing Practice (CGMP) Regulations. 

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice

WHO. Health Products Policy and Standards. WHO.int. 

https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/gmp

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

David Basile, VP Technical Operations–Americas, Hovione

David Basile joined Hovione as VP Technical Operations–Americas in 2021. David has 25 years of experience as a global pharma manufacturing executive with special focus on operational excellence and engineering. During this time, he held several positions including Global Director of Engineering, Automation & Reliability at Catalent Pharma Solutions where he oversaw strategic capital expansions for several business units in the Americas. Prior to this David spent fifteen years with Teva/Actavis in a variety of technical leadership roles over the northeast US region. He holds a Master of Science Degree in Systems Engineering from NJ Institute of Technology, a Bachelor of Science degree in Mechanical Engineering from the University of Notre Dame and is a trained Lean Six Sigma Black Belt.

Good manufacturing practices (GMPs) are essential for maintaining pharmaceutical manufacturing standards globally, focusing on cleanliness and equipment maintenance to prevent contamination. Facilities must adhere to risk-based maintenance programs, with regular evaluations and updates driven by client needs, market demands, and technological advancements. Equipment evaluation is guided by a site's validation master plan, typically occurring every three to five years, involving risk assessments and corrective actions. Continuous modernization and investment in advanced technologies are crucial for maintaining compliance and ensuring reliable supply chains in the pharmaceutical industry.

David Basile, VP Technical Operations, Americas, Hovione, explains what regulators expect for the maintenance of GMP facilities and equipment.

Regulatory Expectations for Evaluating GMP Facilities and Equipment

NEXTEN Event. Image courtesy of IMA Active.

® spoke with Luca Cavazzini, Sales & Marketing director at IMA Active, a division of IMA Pharma, at the company’s NEXTEN event, which was held in Lake Como, Italy in October 2025, to learn more about some of the challenges facing pharmaceutical manufacturers and how IMA Active addresses these challenges. IMA Active provides technologies for oral solid dose manufacturing, as well as integrated systems and services that help pharmaceutical companies accelerate time-to-market within a regulatory compliance environment.

PharmTech: In what ways is the drive for sustainability influencing facility design and equipment selection/upgrading?

 Sustainability has become a strategic pillar for pharmaceutical manufacturing, influencing not only facility layouts but also the way equipment is designed and implemented. At IMA Active, we see sustainability as a combination of efficiency, resilience, and compliance. This means integrating energy-efficient systems, compact footprints, modular design, and predictive maintenance to extend machine lifecycle and reduce resource consumption.

DOMINA tablet press. Image courtesy of IMA Active

A clear example is DOMINA, our latest tablet press. It combines advanced control systems with real-time monitoring to minimize energy usage and scrap. Features like Energy Diary give manufacturers full visibility of consumption, enabling data-driven decisions for greener operations. Its modular architecture supports gradual investment and reduces downtime, while adaptive automation ensures consistent quality with minimal waste.

Ultimately, sustainability is not just operational, it’s strategic. By embedding these principles into our technology roadmap, we help pharmaceutical companies achieve environmental goals while maintaining productivity and regulatory alignment. This approach ensures long-term stability and a future-ready production model.

Which recent innovations in product development or process optimization have had the broadest impact on cost, quality, or speed-to-market in manufacturing operations?

At IMA Active, recent innovation has focused on continuous processes and specialized applications that deliver measurable benefits in efficiency and quality. Our Continuous Direct Compression (CDC) technology offers a lean and flexible tableting solution that, combined with PAT [process analytical technology] tools, enables rapid achievement of a state of control and eliminates waste during start-up and shutdown. Alongside CDC, our Continuous Coaters complete the range for high-throughput coating, ensuring consistent performance for large batches. In capsule filling, we have introduced dedicated solutions for dry powder inhalers (DPIs), meeting growing demand for respiratory therapies with precision and reliability.

The most transformative innovation is modularity. Modular tablet compression platforms deliver competitive advantages globally by enabling rapid format changes, scalability for gradual investment, and seamless integration with Pharma 4.0 concepts. They improve operational efficiency and sustainability while adapting to diverse market needs.

DOMINA embodies this vision. Its plug-and-play architecture, patented Dynamicam filling system, and adaptive automation ensure precision and flexibility. Combined with brushless motorization and servo-assisted changeovers, DOMINA minimizes downtime and maximizes quality, helping manufacturers cut costs, speed up production, and embrace the future of smart manufacturing.

What role do artificial intelligence (AI) and digital technologies play in improving manufacturing efficiency, and what are some unresolved barriers to full adoption?

AI and digitalization are transforming pharmaceutical manufacturing, and at IMA Active we apply them in a practical, process-driven way. Our machines integrate advanced algorithms for real-time optimization, predictive analytics, and preventive diagnostics. This enables automatic adjustment of production settings based on sensor data, while continuously monitoring operating conditions to detect anomalies early.

Digital technologies also enhance usability: guided interfaces and advanced diagnostics simplify operator decisions and reduce human error. These systems improve product quality, minimize waste, and increase process stability.

However, adoption faces critical challenges: balancing advanced automation with intuitive usability for operators, ensuring high-quality and integrated datasets, and meeting regulatory demands for explainable AI and data integrity. Cultural and skill gaps also persist, requiring robust training and change management.

What are the other biggest challenges that you see in your market that should be addressed in the coming year?

Pharmaceutical manufacturing faces a convergence of challenges that go beyond technology. Regulatory complexity is increasing, with global frameworks demanding stricter compliance and data integrity.

Supply chain resilience remains a priority, as companies work to strengthen continuity and flexibility in a dynamic global scenario, while sustainability and environmental transparency are becoming non-negotiable priorities. Digitalization introduces its own challenges: integrating legacy systems, ensuring cybersecurity, and balancing advanced automation with intuitive usability for operators. Finally, the growing need for specialized skills calls for continuous training and cultural transformation.

These challenges are not obstacles; they are catalysts for innovation. They push us to design smarter technologies, strengthen global service networks, and create solutions that combine flexibility, compliance, and sustainability. At IMA Active, we see this as an opportunity to lead the transition toward a more resilient and future-ready pharmaceutical ecosystem.

We respond to market challenges with a comprehensive strategy that goes far beyond equipment supply. We deliver complete solutions, from standalone machines to fully integrated lines, combining engineering, automation, and software to meet the evolving needs of pharmaceutical manufacturers. Innovation and digitalization are at the core of our roadmap: we embed Pharma 5.0 principles into every technology, leveraging real-time monitoring, predictive analytics, and digital twins to optimize processes, reduce downtime, and ensure data integrity. Continuous manufacturing reflects our commitment to future-ready production models.

Equally important is our global support network and Competence Centers, which accelerate innovation through trials, scale-up, and process optimization, while providing training and lifecycle assistance to guarantee operational continuity. Sustainability also drives our vision: energy-efficient systems, modular architectures, and intelligent control features minimize waste and environmental impact while adapting to diverse regional requirements.

By integrating technology, digital transformation, and service excellence, we help pharmaceutical companies turn complexity into opportunity, building efficient, compliant, and sustainable production ecosystems worldwide.

Luca Cavazzini is Sales & Marketing Director at IMA Active, a division of IMA Pharma

Luca Cavazzini is Sales & Marketing Director at IMA Active, a division of IMA Pharma, who's mission is to deliver advanced technologies for oral solid dose manufacturing, combining mechanical excellence with digital innovation. Luca's role focuses on aligning market needs with our technological roadmap, developing solutions that anticipate regulatory, operational, and sustainability challenges. Beyond machines, the company aims to provide integrated systems and services that help pharmaceutical companies accelerate time-to-market while ensuring quality and compliance.

Sustainability is a strategic focus in pharmaceutical manufacturing, influencing facility design and equipment selection. IMA Active integrates energy-efficient systems and modular designs to enhance efficiency and reduce resource consumption. Innovations like Continuous Direct Compression and modular tablet compression platforms improve cost, quality, and speed-to-market. AI and digital technologies optimize manufacturing processes, though challenges remain in data integration and regulatory compliance. Addressing market challenges involves comprehensive strategies, including digital transformation and global support networks, to create efficient, compliant, and sustainable production ecosystems.

Luca Cavazzini, Sales & Marketing Director at IMA Active, discusses some of the industry’s most common manufacturing challenges, such as sustainability, continuous processes, and technology advancements.

Optimizing Pharmaceutical Manufacturing Efficiency

a clinical-stage biopharmaceutical company

, announced on Dec. 2, 2025 that FDA has granted the company’s FS2 (kynurenic acid) orphan drug designation (ODD) for the investigational treatment ofidiopathic pulmonary fibrosis (IPF) (1). Identified by the University of British Columbia as a potential candidate for clinical research, FS2 (kynurenic acid) is a topical treatment for scars and the systemic treatment of organ fibrosis.

According to BirchBioMed, IPF is a serious, rare chronic lung disease that results in thickening and stiffening of lung tissues surrounding the alveoli in the lungs, potentially causing permanent scarring of the lungs and making breathing difficult. FS2 (kynurenic acid) demonstrated scar prevention during preclinical trials. It also showed a breakdown and reduction of existing scars externally and internally that were the result of injury, surgery, or disease (1).

“A subsequent Phase II randomized double-blind clinical trial comparing the safety and efficacy of topical FS2 cream demonstrated superior, statistically significant efficacy on mature keloid scars as compared not only to the vehicle control but to a market leading scar cream,” the company stated in the press release (1). “FS2 is unique in its therapeutic category as it targets scarring on the molecular level.”

Why is orphan drug designation important?

 promotes development of treatments for rare diseases that impact fewer than 200,000 people in the United States by granting companies market exclusivity for seven years post approval, exemption from user fees, tax credits for qualified clinical testing, and more (2). IPF impacts fewer than three million to five million people in the world, and it does not currently have a cure (1).

"Being granted orphan drug designation by [FDA] is a pivotal milestone in BirchBioMed's development of FS2 for the treatment of IPF, a debilitating and fatal disease that has no more than a 5-year life expectancy after diagnosis," Mark S. Miller, chairman and CEO of BirchBioMed, said in the press release (1). "[FDA's] designation provides BirchBioMed with development and commercial capabilities to address this high, unmet medical need."

"This ODD indicates the scientific value of FS2 in the investigational treatment of IPF and underscores the opportunity for IPF patients to participate in our clinical trials,” Carlos Camozzi,chief medical officer, BirchBioMed, stated in the release (1). “BirchBioMed is seeking regulatory approval to begin clinical trials on the systemic use of FS2 for the treatment of organ fibrosis, beginning with IPF early next year. As experts in the development of products for scarring and other fibrosis-related disorders, we are laser focused on FS2's potential to transform the lives of people suffering from this severe, chronic, deteriorating, irreversible, life-threatening lung disease."

What more is happening in the rare diseases space?

®’s November 2025 Drug Solutions Podcast gathered industry experts to discuss novel modalities for the treatment of rare diseases, including advancements in oncology (3). Listen to Sarah Hein, PhD, co-founder and CEO, March Biosciences; Joe Katakowski, PhD, director of research for the RTW Foundation; and Dan Williams, PhD, co-founder, executive director, and CEO, SynaptixBio, discuss the role of patients’ families in accelerating R&D for these rare conditions in the podcast at 

 by Hibreniguss Terefe, director, Product Development Somerset at Ardena, which outlines common chemistry, manufacturing, and controls challenges that steal momentum and create costly detours in the development or orphan drugs (4).

U.S. FDA Grants BirchBioMed Orphan Drug Designation for FS2 in the Treatment of Idiopathic Pulmonary Fibrosis

FDA. Designating an Orphan Product: Drugs and Biological Products. 

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products

Lavery, P. Drug Solutions Podcast: Innovations in Orpah Drugs for Rare Diseases. 

https://www.pharmtech.com/view/drug-solutions-podcast-innovations-in-orphan-drugs-for-rare-diseases

Terefe, H. The Push for Momentum, Not Mistakes in Orphan Drug Development. 

https://www.pharmtech.com/view/the-push-for-momentum-not-mistakes-in-orphan-drug-development

BirchBioMed has received FDA orphan drug designation for FS2 (kynurenic acid) for idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease. FS2, initially identified by the University of British Columbia, has shown promise in preclinical trials for scar prevention and reduction. The orphan drug designation provides benefits like market exclusivity and tax credits, crucial for developing treatments for rare diseases. BirchBioMed plans to start clinical trials for FS2's systemic use in organ fibrosis, emphasizing its potential to transform IPF treatment.

FDA has granted orphan drug designation to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis.