CPHI Barcelona round table discussion 29th January 2024
After the doors closed on CPHI Barcelona in October, a round table discussion was held to discuss emerging trends in the pharmaceutical industry. These are the views expressed by six leading experts in the field.
CordenPharma: Dr Michael Quirmbach, CEO & President of CordenPharma, declared that over the past year, CordenPharma had achieved remarkable milestones in the pharmaceutical and biotech industry. He said: “The company’s involvement in launching innovative medicines for both orphan diseases and larger conditions, such as diabetes, showcases our commitment to making a significant impact on patients’ lives. The excitement about our products and innovations is evident, with substantial investments in expanding our capabilities.
“Our ambitious €500 Million CapEx expansion program over the next three years, especially in key areas such as small to large-scale peptides, oligonucleotides, Lipid NanoParticle (LNP) formulation, specialised lipid excipients and new offerings for highly potent and oncology Oral Solid Dosage (OSD) manufacturing is setting the stage for continued growth to meet the market demand in those important areas.
“We also have a continued focus on sustainability, as demonstrated by our participation in the Science-Based Targets initiative (SBTi), where we are committed to reducing global emissions by evaluating and setting science-based reduction targets, which reflect an ongoing, proactive approach to environmental responsibility. In addition, we have utilised green technologies such as innovative methods for recycling solvents, Supercritical Fluid Chromatography (SFC) and continuous manufacturing to demonstrate our commitment to ESG manufacturing processes, which is increasingly essential in all global industries, including the life sciences.
“Key takeaways on the agenda at CPHI Barcelona included supply chain resilience and diversification, which are critically important topics for our customers. CordenPharma’s ability to support a resilient supply chain and drive innovation with greener manufacturing processes is highly valued by clients, as the whole world continues to face geopolitical challenges and sustainability concerns.
“Ultimately, CordenPharma’s CDMO success goes beyond capacity. It’s rooted in its dedicated team, close collaboration with customers and unique capability to provide end-to-end solutions from early stage to commercial production of APIs and drug products, ensuring that we not only meet our customers’ needs, but provide them the added value that supports getting their products to market efficiently and cost-competitively.
“As we look ahead to 2024, our commitment to innovation, sustainability and customer-centric solutions will continue to drive our success in the pharmaceutical industry.”
Purolite: Felix Solamo, Senior Global Director, Field Applications Scientist from Purolite, an Ecolab company, reported that the bioprocessing team at Purolite addressed crucial issues at CPHI Barcelona such as supply chain security and dual-continent supply trends, as well as challenges in meeting market demand for advanced bioprocessing materials. He added, “Supply chain security is a pressing concern and remains at the forefront of Purolite’s agenda, underscoring the company’s commitment to ensuring an uninterrupted flow of critical bioprocessing materials for customers. The industry’s global nature necessitates the implementation of robust supply chain security measures.
“Acknowledging the shift towards sourcing materials and components from multiple continents, we discussed how Purolite is strategically managing its dual-continent supply with the recent news of our second agarose resin production facility to ensure reliability and efficiency to the market. Purolite’s ability to adapt and cater to these evolving supply trends showcased our agility.
“A standout feature of Purolite’s presence at CPHI was the showcase of its novel Praesto HipH resin technology. This innovation has the potential to reshape bioprocessing chromatography by opening a wider window of operation, thereby enhancing process efficiency and, ultimately, product quality. Industry professionals were intrigued by the technology, which is the result of Purolite’s strategic partnership with Repligen, emphasising the demand for advanced solutions within the bioprocessing sphere.”
Quotient Sciences: Dr Paul Quigley, Principal Research Fellow, Drug Substance, Quotient Sciences, stated that the pharmaceutical industry is seeing the emergence of new modalities and new molecular entities (NMEs) for the treatment of complex disease indications in fields such as oncology and chronic and rare diseases. He pointed out that the small molecule drug products (DPs) being brought to market as treatments for these conditions are increasing in complexity and potency.
“As a result, interest in more complex and potent active pharmaceutical ingredients for treating chronic and rare diseases is on the rise. The ability of new modality-based DPs to elicit a beneficial therapeutic effect at low concentrations is placing pressure on contract development and manufacturing organisations (CDMOs) – traditionally positioned to support large-batch manufacturing – to cater to smaller volumes. Therefore, to maintain market advantage, CDMOs must re-evaluate manufacturing practices and instil flexibility to meet changing capacity needs.
“Additional strain is placed on CDMOs as a result of the pharmaceutical industry’s pressures to deliver therapeutics at accelerated rates. Given the current biotech funding constraints, there is an increasing need to reach key clinical outcomes with cost-efficiency. The integration of DP and drug substance (DS) services has enabled these processes to be run in parallel, streamlining the production of essential therapeutics. Therefore, partnering with CDMOs with the capacity to handle both small and large-scale development and manufacture, offer integrated DS, DP and clinical services, and meet containment (low to high-potency) requirements of complex materials, mitigates production risks to reach desired outcomes at speed, with low associated costs.”
Recipharm (Oral Solid Dose): Uwe Hanenberg, Head of Product Development, Oral Solid Dose, at Recipharm commented on the importance of data science in navigating the changing OSD space. “Offering convenient administration, accurate dosing and uniform dose content, oral solid dosage (OSD) formats continue to be the most popular drug form used globally. With various new formulation techniques being explored to enable biologic OSDs, it is no surprise that demand for OSD formats is steadily climbing.
“As we continue to realise the potential of OSDs, it will be increasingly important to overcome issues developers and manufacturers face throughout product development, ensuring these critical medicines reach the patients who need them. This includes navigating cost pressures and demands to reduce timelines, as well as the inherent scientific challenges that come with product development and preparing for robust clinical and commercial manufacturing, such as: drug instability; physicochemical properties; absorption issues; and regulatory requirements.
“Data science is set to become increasingly important in addressing OSD product development challenges and is already playing an integral role in overcoming issues such as tech transfer to different equipment and scale.
“Data science will continue to influence all aspects of drug production from being used for in silico development to optimising facility planning in engineering and providing a holistic view throughout quality assurance. In routine production, data science will reduce deviations while helping to optimise planning, enabling expedited timelines from early development to commercial and allowing vital medicines to reach patients sooner.”
Recipharm (Sterile Fill & Finish): Also working for Recipharm, Vincenza Pironti, PhD, Strategic Marketing Director, pointed out that the biopharmaceutical sector is expanding rapidly, driven by increasing demand not just for existing biologics, but for novel therapies for rare and orphan diseases that currently have no effective treatment. Worth $333.1 billion in 2022, the global biopharmaceutical market is expected to reach a high of $856.1 billion by 2030.
“Biologics are sensitive, which creates manufacturing challenges when meeting the growing demand. Manufacturers need to consider how to efficiently fill large volumes of individual doses while maintaining product stability and sterility. Increasing global demand poses a distribution challenge, as breakage and product wastage can be an issue, particularly when shipping to markets far away from the manufacturing site.
“To help overcome these issues and meet future demand, it is crucial to harness new ways to optimise manufacturing efficiency, such as using alternative container formats. For example, the manufacturing process of blow-fill-seal (BFS) containers can offer cost-effective fill and finish at high volumes. The polymer composition of BFS containers minimises the risk of breakage during transit. Single-dose manufacturing is also possible, reducing wastage from expired products left in multi-dose containers.
“The high temperatures used in traditional BFS manufacturing meant that, in the past, they were incompatible with biologics. However, drug formulation temperature can now be considered during BFS manufacturing. With this in mind, this format can be considered a potential option for sensitive biologics requiring sterile fill & finish.”
Tjoapack: Marcelo Cruz, Vice-President Business Development & Marketing at Tjoapack, confirmed: “Pharmaceutical packaging and supply chain security were at the forefront of discussions at CPHI Barcelona 2023, reflecting the industry’s commitment to supporting the production and delivery of new therapies to patients. The desire to protect pharmaceutical products from counterfeiting, tampering and theft was a central theme. Stakeholders recognised the urgent need to enhance packaging solutions, not only for safety and sustainability, but also to bolster supply chain security.
“Reflecting on what was learned at CPHI, as we look ahead to 2024, the global pharmaceutical industry’s outlook remains optimistic, especially in terms of packaging and supply chain security. Innovations in packaging materials, serialisation and anti-counterfeiting technologies will continue to gain traction, ensuring the authenticity of medicines throughout their journey from manufacturer to patient. These advancements will be crucial for preserving product integrity and patient safety.
“Collaboration between pharmaceutical companies, packaging manufacturers and logistics providers will be instrumental in implementing robust supply chain security measures. This collaborative approach will help in developing and adopting best practices, standards and regulations to safeguard pharmaceutical products as they move through the supply chain. The collective effort to address security issues and enhance packaging and logistics solutions will play a vital role in shaping the industry’s success in 2024 and beyond.”