Date: 6-8 october
Venue: Milan (Italy)
Hall: 9
Stand: C97
Book a meeting for a complimentary technical consultation and discover how FPS Pharma’s cutting-edge containment and micronization solutions can optimize your pharmaceutical production processes.
From enhanced operator safety to maximized process efficiency, our custom systems deliver superior performance at every stage of manufacturing.
Great pharmaceutical processes are not built by adding complexity.
They are built by removing uncertainty.
At FPS Pharma, we engineer custom micronization and containment solutions with one clear purpose: to make critical processes safer, smarter, and more reliable.
Because when control improves, everything runs smoothly.
Simposio AFI | 10–12 June | Rimini, Italy | Booth 125
Il 29 Ottobre 2026 si terrà il convegno organizzato da Techniconsult Group focalizzato su “Strategie di Contenimento nel Settore Farmaceutico: Tecnologie, Normative e Best Practices per l’Industria Farmaceutica”.
🎯 No, non è il solito convegno.
💡L’evento è infatti dedicato ad una tematica altamente specialistica e rilevante, ad oggi poco approfondita nel panorama degli appuntamenti del settore.
🎖️La cornice dell’evento sarà lo Stabilimento Chimico Farmaceutico Militare (SCFM) di Firenze.
FPS Pharma, selezionata tra gli speaker ufficiali del convegno per la sua expertise sul contenimento, è lieta di invitarvi gratuitamente a partecipare come ospiti.
Per l’occasione, il ns Technical Sales Director Ing. Stefano Butti – socio AFI e ASCCA – condividerà una presentazione inedita e altamente formativa che coprirà in maniera esaustiva non solo tutte le tematiche relative al contenimento di HPAPI e sostanze chimiche pericolose, ma anche le più avanzate strategie di contenimento, complessi case studies e molto altro (incluso ciò che raramente viene anche solo accennato ma che ha un peso rilevante su audit, qualità e sicurezza).
📍Non perdere questa occasione irripetibile! I posti sono limitati(ssimi)!!
👉Registrati gratuitamente e assicurati subito il tuo pass nominale: https://tcfirenze.com/evento_strategie_contenimento_firenze/?utm_source=fps
We’re Gold Sponsors of the 2nd Annual EuroPotent 360 Summit, and we’re not here just for the badge on the program.
We’re here because the summit’s core focus (managing highly potent ingredients across the full pharmaceutical value chain) is precisely where FPS Pharma operates every day.
This isn’t a peripheral interest for us. It’s where our expertise lives.
But the moment that’s truly ours is 22nd May.
As the Summit closes, FPS Pharma hosts the closing Workshop: a deep-dive, hands-on session dedicated to Containment Strategies, the latest containment innovation driven by real-world challenges, complex case studies.
A summit opens conversations.
Our Workshop is where those conversations become solutions.
📍 Venue: Radisson Blu Milan, Via Villapizzone 24, Milan, 20156, Italy
🗓️ Date: 20–22 May 2026
📩 Drop a line at marketing@fps-pharma.com for free passes and more information.
Francesca Pia Dossena, QHSE Manager at FPS Pharma, shares how the company integrates quality, safety, sustainability and care for people and the environment into its daily operations.
Francesca, FPS Pharma has nearly 20 years of ISO certifications history and a very well-established integrated system. What has been the guiding principle throughout this journey?
Our guiding principle is simple: people and the environment are at the center of every decision we take.
Twenty years ago, ISO 9001 certification was the first step in building a system that today not only focuses on process compliance and customer satisfaction but also on continuous improvement. This means that every process, procedure and project is designed to protect those who work with us, those who rely on our services, and the environment in which we operate.
FPS has achieved several certifications over the years: ISO 45001, UNI PDR 125, ISO 14001. How do these translate into practice for clients and partners?
Each certification represents a tangible commitment to workplace safety, gender equality and environmental protection. Working with FPS Pharma means knowing that our processes are robust, that internal and external audits are conducted regularly, and that we only collaborate with partners who share our values. These are not just compliance badges, they are concrete guarantees of reliability and responsibility.
Attention to sustainability is increasingly critical. How does FPS integrate it into daily operations?
For us, sustainability is not a goal to communicate, it is an operational principle.
Obtaining the UNI EN ISO 14001 certification and the ECOVADIS Bronze Medal, with a score of 64/100, which places us on the podium of the 35% Top Companies, reflects our responsible practices aimed at reducing environmental impact and promoting a corporate culture attentive to human rights and gender equality.
Every project is managed with care. We want everyone who relies on us to tangibly experience our commitment to attention, safety, and respect—always.
Training is a key focus at FPS Pharma. What added value does it bring to the FPS team and to clients?
Training means empowering people by providing them with the tools and knowledge they need to act in the best possible way.
In line with our continuous improvement approach, we go beyond mandatory training by organizing targeted courses on health and safety, social and environmental sustainability, as well as professional development courses.
This approach has allowed us to cultivate a strong corporate culture where every team member understands their role and acts with care and awareness.
For clients, this translates into the confidence of working with an ethical, competent partner capable of safeguarding what matters most to them.
Looking ahead, what are FPS Pharma’s priorities?
Certainly, to continue refining our management systems and implementing new initiatives in favor of sustainability, safety, and the well-being of people.
Our goal is simple: to ensure reliability, safety, and the highest standards and care in every daily activity.
How can clients learn more about FPS Pharma’s integrated management system?
All documentation is available by contacting our QHSE department at qhse@fps-pharma.com, as well as on our website.
We are always happy to share our certifications, best practices, and values.
FPS is pleased to confirm its presence at Solids.
Date: 11-12 February 2026
Venue: Fiere di Parma (Italy)
Hall 8 Booth: E51
Contact our team and schedule a meeting: marketing@fps-pharma.com
To redeem your pass, click here
In recent assessment cycles, EcoVadis has progressively increased expectations around documentation, evidence depth, and sector benchmarking, making the assessments more selective.
Within this more selective framework, FPS Pharma was awarded the 2026 EcoVadis Bronze Medal, confirming that the company meets the organizational, ethical and governance standards increasingly expected of suppliers operating in regulated pharmaceutical environments. This result is a tangible indicator that FPS Pharma meets recognized benchmarks of organizational reliability under more demanding evaluation conditions.
Why EcoVadis matters in high-risk decision-making processes
EcoVadis has become one of the most widely used assessment standards for the qualification and ongoing monitoring of critical suppliers.
The rating provides a structured analysis across four key areas that directly affect audits, operational continuity and supply-chain resilience:
For customers operating in tightly regulated environments, such as pharmaceutical companies and CDMOs, EcoVadis is increasingly an integral component of vendor qualification processes, supplier assessments, and third-party audits.
It is one of those requirements that, when absent, may raise questions during an audit, while meeting it allows discussions to proceed with greater confidence and efficiency.
EcoVadis Bronze Medal
In supplier selection, particularly for GMP-critical equipment and systems, EcoVadis is not a competition for the highest score, but a risk-screening mechanism designed to verify that a supplier meets an accepted level of organizational maturity and governance.
In this context, the Bronze Medal confirms that FPS Pharma meets the reliability threshold required to operate within regulated pharmaceutical supply chains.
What this result means
For FPS Pharma, sustainability is not a standalone initiative; it is the outcome of how we design, document, and govern our industrial processes, and how our values are translated into daily operational practice.
In an industry where reliability, operational continuity, and compliance are non-negotiable, this recognition provides an additional, audit-relevant layer of assurance for customers making critical qualification and sourcing decisions.
A recognition aligned with a structured industrial approach
At FPS Pharma, we view the EcoVadis result as a milestone within a continuous improvement journey, consistent with a long-term vision focused on:
FPS Pharma continuously invests in strengthening its organizational and industrial processes, with the aim of supporting pharmaceutical customers in their manufacturing, regulatory, and strategic challenges, both today and in the future.
For FPS Pharma, the key question is not “Who has the highest score?” but rather:
“Have we demonstrated a level of governance and process control that reflects our values and that we, and our customers, can confidently defend during qualification and audit?”
FPS Pharma’s 2026 EcoVadis result provides a clear and credible answer within a highly selective assessment framework.
“Achieving this rating in our EcoVadis assessment is the result of a strong team effort and reflects our commitment to continuous improvement.”
FPS Pharma
Engineering excellence for high-containment and pharmaceutical micronization.
Built to perform. Built to protect. Built to be reliable.
Antibody-Drug Conjugates (ADCs) are a relatively new class of therapeutics, with the first promising clinical trial results dating back to the 1980s. Since then, ADCs have undergone robust and exponential growth. Recent market analyses forecast that the ADC market will reach USD 15 billion by 2025 and is projected to exceed USD 40 billion by 2030.
The following factors are primarily responsible for the expansion of the ADC market:
ADCs are engineered to selectively target and destroy cancer cells while sparing healthy tissue.
This precision, however, comes with increasing potency and complexity, making their production a high-stakes endeavor in terms of containment and safety.
Today, the applications of ADCs have expanded to include not only cancer treatment but also autoimmune disorders and infectious diseases.
ADCs are continuously evolving and increasing their efficacy to eliminate the targeted cells – e.g. cancer cells – while preserving healthy tissue. This feature leads to its success and to its rapid growth, which in turn leads to higher production.
The end result is an increase in containment complexity.
Typically, ADCs consist of three elements – a monoclonal antibody, a linker (that could be cleavable which are almost 80% or non-cleavable) and a cytotoxic payload – where the antibody is conjugated to the cytotoxic payload via a linker.
Innovations in cancer research have also led to the development of dual-payload ADCs. This new class is highly promising, as conjugating two payloads with different mechanisms of action (MOAs) can significantly enhance therapeutic efficacy and reduce relapse rates. However, the more complex the structure, the more intricate and challenging the manufacturing process becomes.
The production of antibody drug conjugates involves many critical phases starting from cell culture (such as CHO cells for example) to produce the antibody. It then progresses thought the synthesis of the anti-cancer drug(s) and of the linker(s), followed by conjugation, purification, formulation, final filling, and packaging of the finished therapeutic dose.
Each phase presents inherent different risks and requires specific containment strategies.
Monoclonal antibodies (mAbs) are proteins synthesized in the laboratory to mimic the function of antibodies found in the human immune system. They are usually made by animal/mammalian cells (such as CHO, (Chinese Hamster Ovary)) which are cultivated under strictly controlled conditions.
The next step involves the clarification of the solution and the antibody purification. This phase poses minimal health risks, as mAbs are not inherently toxic. However, depending on the production method, there may be potential exposure to biological agents (e.g., bacteria, viruses), so containment strategies must be evaluated on a case-by-case basis. cGMP cleanrooms and closed systems as well as BSCs or aseptic containment isolators are therefore necessary to preserve the sterility of this process and prevent contamination. While mAb production poses relatively low risk to operators, the same cannot be said for the synthesis of the cytotoxic payload.
This is unquestionably the most hazardous phase in ADC production.
Payloads are often rated OEB 5 up to OEB 7, they can be lethal in infinitesimal quantities, and may pose a risk of DNA damage. Due to their extreme toxicity, this phase requires the use of aseptic high-containment isolators to simultaneously protect operators, the environment, and the cytotoxic compound from contamination. These isolators typically operate under negative pressure to protect the operators while grade A airflow protect the product. Those isolators are equipped with glove ports, HEPA filters, closed transfer systems, and integrated cleaning and decontamination systems. In contrast, linker toxicity depends on its chemical structure, and its synthesis poses safety risks because it implies the handling of active chemicals and solvents. Therefore, aseptic containment isolators are also used in this phase, with containment depending on OELs.
Next, we move into the conjugation, purification, and quality testing phases, all of which share similar safety risks for operators due to the presence of cytotoxic payloads—while also requiring strict process sterility. For these reasons Aseptic high-containment custom isolators (from OEB5 up to OEB 7) play a critical role in ensuring safe and sterile operations. The final phase is formulation and fill-finish, where the ADC is prepared in its final buffer and filled into vials or syringes. Fill-finish operations are conducted in Grade A isolators, which provide a sterile environment and high containment. FPS Pharma custom fill-finish isolators can be easily integrated with automated filling lines and equipped with CIP and SIP systems to ensure the utmost safety and efficiency. As we’ve seen, ADC is a multi-phase process that demands strict aseptic conditions, high-potency API containment, and full compliance with regulatory guidelines to ensure both operator safety and product quality. Each phase presents distinct challenges and risks, requiring a comprehensive approach to risk management, along with the right containment strategies and safety protocols. FPS Pharma is globally renowned as a trusted partner in the engineering and manufacturing of innovative, custom high-containment isolators used for handling and producing highly potent and sterile pharmaceutical ingredients—such as ADCs, a class of HPAPIs. Given that every ADC manufacturing process presents unique requirements, only custom aseptic containment isolators designed for toxic applications can ensure full regulatory compliance and meet all necessary safety and quality standards. FPS Pharma recognizes how critical Occupational Exposure Limits (OELs) are in the production of Antibody Drug Conjugates (ADCs) due to the unique and ultra-potent nature of these compounds. For this reason FPS Pharma engineers Occupational Exposure Band (OEB) isolators—from OEB 4 up to the latest OEB 7—equipped with advanced safety and monitoring systems tailored to your specific process and OEL requirements, ensuring safe and compliant ADC operations.
Date: September 25-26, 2025
Location: Duo Milan Porta Nuova
As gold SPONSOR and SPEAKER, we are glad to announce the upcoming Maxpotent Pharma Summit taking place 𝗳𝗿𝗼𝗺 25𝗻𝗱 𝘁𝗼 26𝘁𝗵 𝗠𝗮𝘆 𝟮𝟬𝟮𝟰, in the vibrant city of 𝗠𝗶𝗹𝗮𝗻, Italy.
Date: October 28-30, 2025
Venue: Frankfurt
Booth: 9.0D57
Visit us to experience firsthand our patented, innovative glove leak tester—the most reliable, user-friendly, fast, and accurate solution on the market (with even more benefits to see yourself!).
Book a meeting for a complimentary technical consultation and discover how FPS Pharma’s cutting-edge containment and micronisation solutions can optimise your pharmaceutical production processes.
From enhanced operator safety to maximised process efficiency, our custom systems deliver superior performance at every stage of manufacturing.
