How to proceed with non-pharmacopoeial excipients in the formulation of a medicinal product for human use? - ATESSIA, Life Science Advisors
French always do it different In many domains, French people like to stand out, either in a positive or negative way. In the Healthcare field, France has set a system that is highly effective, and very protective for the patient, but at the price of a heavy state involvement and of one of the most complex regulations. As a result, understanding the regulatory specificities of France is key for entering the French market. ATESSIA can help you in this process and provide you assistance and expertise. Here are a few areas where France follows its own, often complicated
– Excipients – inherently inactive – have a wide range of applications and are essential components in the formulation of medicines. However, few of these components are manufactured exclusively for pharmaceutical use. Often, the pharmaceutical use of an excipient represents only a minor fraction of its other industrial uses (food, cosmetics or others). However, the quality of excipients is crucial to ensure the quality, safety and efficacy of medicines.
– There is no registration or authorisation procedure prior to its use in a medicinal product. Implicit agreement for the acceptability of an excipient can only be obtained on the basis of a complete marketing authorisation dossier. Excipients used in the formulation of medicinal products can be classified into two main categories: known excipients (i.e. described in the literature, e.g. Handbook of Pharmaceutical Excipients, in the regulations, e.g. (EU) Regulation n°231/2003, or previously screened for risk/safety by an international organisation, e.g. JECFA, FAO, WHO) and unknown excipients, so-called “new excipients” (i.e. used for the first time in a medicinal product or via a new route of administration according to ICH M4Q).
Stay ahead of the industry with exclusive feature stories on the top companies, expert insights and the latest news delivered straight to your inbox. Subscribe today.
– Among the known standard excipients used, the European guidelines of the EMA provide for two categories: those described in a pharmacopoeia (e.g. European, American, Japanese, French, British, etc.), and those not described in a pharmacopoeia. The latter are then subject to “in-house” control specifications, generally based on the excipient manufacturer’s own specifications, which may be consolidated by the MA holder depending on the use of the excipient in its formulation. It should be noted that in the case of mixed and co-processed excipients, a combination of one or more excipients described or not described in a pharmacopoeia may be considered.
– In Europe, the European Pharmacopoeia is the binding reference for substances for pharmaceutical use. Nearly 200 monographs for excipients are included. Increasingly, they include additional pharmaco technical specifications depending on the use of the excipient. The aim of the European Pharmacopoeia excipient monographs is to provide authorities and patients with a guarantee of acceptable quality. The national pharmacopoeias of the EU Member States are also considered as reference documents that can be used without providing a specific justification in the marketing authorisation dossier. A reference to the “current edition” of the European/national pharmacopoeia in the marketing authorisation dossier is expected to avoid subsequent maintenance changes to the marketing authorisation dossier.
– For the same excipient, depending on its various possible origins and uses, different additional requirements may also be necessary: e.g. with regard to a chemical risk (residual solvents according to ICH Q3C, elemental impurities according to ICH Q3D, nitrosamine impurities, etc.), with regard to a bacteriological risk (mycotoxins, endotoxins, sterility, etc.), or with regard to a viral risk (TSE/BSE).
More in News
Shortages in generic and biopharmaceutical medicines rarely begin as a single missed shipment. They build earlier, in product selection, dossier timing, plant readiness, inspection discipline and the handoffs between development teams and commercial supply. Healthcare systems and pharmaceutical partners face more than price exposure. A low-cost product that reaches the market late, produces incomplete regulatory documentation, strains sterile capacity or fails to sustain supply can create treatment gaps that procurement teams cannot correct once contracts are awarded.
The buying decision has moved beyond simple generic substitution. Sterile injectables and biosimilars carry tighter technical demands, while European launch planning adds country-by-country complexity in access policy, reimbursement, tender timing and route-to-market execution. Companies need development partners who can meet quality requirements while managing the economic pressures that drive the adoption of generics and biosimilars. This balance is difficult when discovery, clinical work, manufacturing and market entry are organised into disconnected supplier arrangements. Each handoff adds room for delay, unclear accountability, cost drift and late discovery of supply constraints.
Capacity alone does not settle the question. Value comes from operations that are audit-ready, disciplined in production planning and transparent throughout the supply chain. Customers benefit when manufacturing partners work within a shared planning rhythm. Procurement and commercial teams identify issues earlier when both sides align on demand, filing schedules, quality assessment and supplier risk. Close alignment prevents cost pressure from eroding quality standards or pushing corrective work past the launch calendar.
Portfolio strategy carries equal weight. A partner built solely around commodity generics may struggle when buyers need sterile dosage forms, peptides, complex injectables and biosimilars on a single development path. Breadth becomes a liability without disciplined product choice and clear market sequencing. Selective expansion is the stronger path, backed by investment in development capacity, credible regulatory preparation, experienced European staff and a realistic view of market entry. Europe is not one launch environment. It is a cluster of pricing rules, health system practices, tender calendars and local access requirements. The real question is whether a partner can connect scientific development, compliance preparation, manufacturing scale and commercial timing without leaving the buyer to manage every gap.
Evumed Limited’s model centres on pharmaceutical development and commercialisation as a whole. Its European headquarters in Cork, Ireland, covers regulatory affairs, quality, supply chain management and commercial support. Its strategic partnership with Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd and Evumed Singapore, adds depth to its manufacturing and research and development. Its portfolio spans generic medicines, sterile injectables, peptides and biosimilars, backed by FDA-inspected facilities, expanding sterile production capacity and continued biosimilar investment. Development, manufacturing and market access work as a connected system, built to sustain supply and shorten the path to European market entry. ...Read more
Bioprocessing pump manufacturing is crucial in the biopharmaceutical, biotechnology, and industrial sectors. The industry continues to evolve due to various influencing factors, technological trends, and the increasing demand for precision in fluid handling. Manufacturers constantly refine their processes and equipment to meet industry requirements, adhere to strict regulatory standards, and improve efficiency. Automation and digitalization have revolutionized pump manufacturing.
The products require precise fluid management to maintain product integrity, pushing pump manufacturers to develop specialized solutions to ensure sterile and contamination-free operations. Pumps must handle various fluids, from aqueous solutions to highly viscous and shear-sensitive materials. The development of biocompatible, corrosion-resistant materials, such as stainless steel, PTFE, and single-use plastics, has allowed manufacturers to produce pumps that meet stringent hygiene and safety standards.
Modern bioprocessing facilities require pumps with advanced control systems, integrated sensors, and real-time monitoring to optimize fluid flow, minimize waste, and enhance efficiency. Automation reduces human intervention, lowering contamination risks and ensuring consistent production quality. Pumps must also comply with good manufacturing practices (GMP) and be easy to sterilize and clean, which ensures product safety and quality for manufacturers.
Future of Bioprocessing Efficiency
Companies seek energy-efficient pumps that reduce operational costs and environmental impact. Developing low-energy-consuming and recyclable pump components supports sustainability efforts while maintaining high performance. The bioprocessing pump industry is witnessing several trends that shape its future. Single-use pumps eliminate the need for extensive cleaning and sterilization, reducing downtime and cross-contamination risks. The pumps are particularly beneficial in biopharmaceutical applications, where sterility is paramount.
"Modern bioprocessing facilities require pumps with advanced control systems, integrated sensors, and real-time monitoring to optimize fluid flow, minimize waste, and enhance efficiency."
The rise of Industry 4.0 has led to the development of intelligent pumps equipped with IoT connectivity, real-time monitoring, and predictive maintenance capabilities. These features allow manufacturers to monitor pump performance remotely, detect issues early, and optimize maintenance schedules, reducing operational costs and increasing uptime. The demand for modular and scalable pump systems is growing. As bioprocessing facilities expand and adapt to new production requirements, manufacturers require flexible pump solutions that can be easily upgraded or modified.
Modular pump designs offer versatility and integrate easily into different bioprocessing setups. The shift toward continuous bioprocessing enhances efficiency, reduces production time, and minimizes variability. Pumps for constant operation must provide precise flow control, high reliability, and minimal downtime. These pumps are essential in various industries for fluid handling, ensuring product consistency and safety.
Pumps are essential for accurately transferring active pharmaceutical ingredients (APIs), buffers, and culture media in chromatography, filtration, and cell culture. In biotechnology, they facilitate cell cultivation, fermentation, and media preparation, ensuring optimal nutrient delivery and waste removal for ideal cell growth. Maintaining precise flow rates and minimizing shear stress is crucial for preserving cell viability. Additionally, bioprocessing pumps are used in the food and beverage industry to handle sensitive ingredients and flavorings.
Developments in Sanitary Pump Design for Bioprocessing Applications
Maintaining hygiene and preventing contamination is essential, making sanitary pumps with CIP (clean-in-place) and SIP (sterilize-in-place) capabilities indispensable in this sector. Industrial bioprocessing applications, such as biofuel production, utilize pumps to transfer feedstocks, enzymes, and fermentation products. The pumps must withstand corrosive and high-viscosity fluids while maintaining efficient performance over extended periods. Manufacturers face several challenges in designing and producing pumps that meet industry needs.
Some bioprocessing applications involve highly viscous, shear-sensitive, or foaming liquids that require specialized pump designs to maintain integrity and prevent degradation. Pumps used in the pharmaceutical and biotech industries must meet strict hygiene standards and be constructed from materials that comply with FDA, USP Class VI, and other regulatory requirements. Achieving compliance while maintaining cost-effectiveness requires careful material selection and design innovation. Sterility and contamination control pose additional difficulties.
Manufacturers must develop pumps with superior cleanability, minimal dead spaces, and compatibility with sterilization techniques such as gamma irradiation and autoclaving. Maintenance and longevity are critical concerns. Pumps must operate reliably over extended periods while minimizing downtime and maintenance requirements. The integration of advanced digital technologies presents opportunities and challenges.
Enhanced Efficiency and Compliance
Manufacturers utilize high-performance polymers, coated stainless steel, and elastomers with enhanced chemical and thermal stress resistance. The materials ensure longevity, compliance, and superior hygiene in bioprocessing applications. The adoption of automation and innovative monitoring technologies is transforming the industry. Pumps equipped with real-time sensors, automated flow control, and predictive maintenance capabilities improve process efficiency and reduce downtime. AI-driven analytics help manufacturers optimize performance, detect potential failures, and enhance overall reliability.
Single-use pump solutions are gaining popularity as they eliminate the need for cleaning validation and reduce contamination risks. These pumps offer cost-effective, flexible solutions for biopharmaceutical applications, particularly in small-batch production and personalized medicine. Collaboration between manufacturers, regulatory agencies, and research institutions is vital in advancing pump technology. By working together, stakeholders can develop standardized protocols, enhance regulatory frameworks, and drive innovation in bioprocessing pump manufacturing. ...Read more
Digital advances in healthcare and wellness are changing longevity supplement services. These services now combine nutrition knowledge with digital tools like mobile apps and wearable devices. Companies are focusing more on personalized wellness that supports long-term engagement and measurable results, rather than just short-term product use. The market is growing as more people focus on preventive health, the aging population increases, and digital tools become a regular part of daily wellness routines.
Digital Transformation Reshaping Preventive Longevity Ecosystems
Digital transformation is changing how longevity supplement services are delivered. Instead of just selling supplements, companies are now creating connected wellness programs that integrate health assessments, wearable devices, mobile apps, and subscription services into a single system that provides recommendations based on users' daily habits, such as diet, sleep, exercise, and lifestyle. As a result, wellness support is becoming more personal and ongoing, with a focus on long-term health rather than one-time purchases.
A major reason for this shift is the growing focus on preventive healthcare. More people are trying to maintain good health early rather than dealing with illness later, which has increased interest in structured wellness programs that combine supplements with ongoing tracking and feedback. At the same time, aging populations in many regions are adding pressure on healthcare systems, which is pushing interest toward prevention and long-term wellness support.
Data-driven systems help companies understand user behavior more effectively by identifying patterns related to sleep, energy levels, stress, and overall well-being information helps improve supplement recommendations and makes them more relevant over time. Cloud-based tools also allow users to access their health information across devices, helping them stay consistent with their wellness routines and maintain better long-term habits.
At the same time, companies are improving how they operate. Many processes, such as subscription handling, inventory planning, customer support, and order management, are now more automated, reducing manual effort and helping businesses manage growing demand more efficiently. As a result, digital systems are becoming a core part of how modern longevity services operate.
Personalized Wellness Improving User Health Outcomes
Personalization has become one of the strongest drivers of growth in the longevity supplement space. Instead of offering the same products to everyone, companies are focusing on creating individual supplement plans based on personal needs. These plans are usually designed using information such as age, lifestyle habits, dietary preferences, and wellness goals, making the experience more relevant and useful for each user. Wearable devices and health apps play an important role in this system, continuously collecting data on sleep patterns, heart rate, physical activity, and stress levels, helping users and companies adjust wellness plans based on real-life changes rather than fixed schedules.
People’s expectations have changed a lot. They now want clear explanations, easy ways to track progress, and honest information instead of vague claims. Because of this, companies are offering tools that help users keep a closer eye on their health in a simple way. These tools show improvements, daily habits, and how everyday routines affect overall wellness.
The focus has shifted from just taking supplements to actively managing health over time. Mobile apps make this even easier by letting users track their intake, set reminders, get personalized suggestions, and check their progress on their phones. This regular interaction helps people stay consistent with their wellness routines, which is important for achieving better long-term results.
Users have a stronger sense of control over their health decisions. Personalization also helps companies keep users engaged for longer periods. When services adjust to individual needs and clearly show value, people are more likely to continue using them. This has encouraged companies to improve user experience and make their systems more useful, simple, and easy to use.
Global Expansion Supported By Connected Wellness Infrastructure
Global expansion is accelerating as digital systems make longevity-supplement services easier to access across regions. Companies can now reach customers in multiple countries without relying heavily on physical distribution networks, reducing complexity and enabling faster expansion while maintaining consistent service quality. Emerging markets are important for growth. Rising incomes, health awareness, and interest in preventive wellness are increasing the demand for simple, affordable health solutions.
Digital platforms help companies enter new markets without investing heavily in local infrastructure and allow them to grow faster while controlling costs and operational challenges. Partnerships are also driving growth in the industry. Supplement companies work with healthcare providers, research groups, and technology partners to improve how they develop and deliver products.
The collaborations enhance product quality, enable more effective testing, and build greater trust in wellness solutions among consumers. At the same time, rules and guidelines around health products are becoming clearer. Authorities' greater attention to health claims and to how user data is handled is encouraging companies to be more transparent and to rely on better evidence when presenting benefits. ...Read more
Antibody production has become critical in the biopharmaceutical industry as healthcare systems, research institutions and investors keep pushing for more advanced therapeutic development. The market is still moving forward through better cell line engineering, bioprocess optimization and manufacturing technologies that aim for higher efficiency plus steadier performance.
Since demand is expanding across multiple therapeutic areas, organizations are rethinking production strategies to juggle quality, scalability, and cost control. This whole setting has also nudged stronger collaboration across development, manufacturing and supply networks, so operational excellence is starting to look tied to commercial success. Companies that can match scientific novelty with disciplined execution are often in a stronger position to react to shifting market needs and long-term growth paths.
What Are the Future Trends in Manufacturing Economics?
With demand for antibody therapies continuing to rise, manufacturers are putting money into flexible production platforms that can handle different batch sizes and shifting development timelines. More advanced automation and data-driven monitoring are boosting process visibility, and they help make output feel more predictable. Still, decision makers are under pressure to manage capital expenditures, stay compliant with regulations, and cut production costs where possible. Contract manufacturing relationships keep showing up in capacity planning because they can offer specialized infrastructure and technical know-how.
Organizations are placing greater emphasis on forecasting accuracy and supply chain resilience to minimize operational disruptions. As evidence generation and cross-functional planning become more integrated, Princeton Biopartners supports biopharma teams with AI-powered evidence planning and data dissemination capabilities that strengthen informed decision-making across development programs. Coordinating research, production quality oversight, and distribution functions is increasingly becoming a competitive differentiator that contributes to stronger commercial performance. Organizations with well-managed manufacturing networks are better positioned to support expansion while improving resource utilization across global operations and regional markets.
How Can Producers Address Scaling and Cost Pressures?
As antibody pipelines keep expanding, organizations are running into fresh hurdles tied to scaling, technology transfer, and process consistency. Keeping product quality steady when volumes grow demands rigorous validation approaches supported by dependable analytical methods. Supply chain complexity is still a big factor too, because raw material availability, equipment readiness, and logistics coordination can all affect the manufacturing schedule. Also, rising expectations for cost efficiency are pushing producers to rethink workflow design, invest in workforce development and lean harder into digital integration. Using advanced analytics can spotlight process improvements and allow quicker reactions to operational deviations.
True Marker Pharmaceuticals strengthens supply chain resilience through compliant pharmaceutical distribution and reliable operational support for independent pharmacies.
Strategic planning matters just as much because scaling moves often stretch across long investment horizons, with complicated regulatory requirements attached. Organizations that judge market demand alongside production capability are generally positioned to assign resources more effectively. Collaboration between scientific groups, operations specialists, and procurement functions helps create clearer choices and aligns business goals with day-to-day technical execution.
The sector is expected to stress efficiency, scalability, and supply reliability as major drivers of competitiveness. Real progress will depend on balancing innovation with strict operational control and keeping enough flexibility to adapt to changing customer expectations. By tightening manufacturing strategies and investing in sustainable capabilities, organizations can achieve consistent growth, boost profitability, and meet stakeholder expectations across the value chain. ...Read more
