Articles

Pharma Innovation a World Pharma Today Round Table

It becomes imperative that innovations keep upgrading in the pharmaceutical sector, be it clinical trials or the supply chain. As drug development and storage become more intense, there is indeed a significant need to upgrade across the entire supply chain. Let’s take a look at how the industry is going through a consistent shift in this regard for outcomes that are better, broader, and bigger.

ACCORDING TO PUROLITE

The bioprocessing team at Purolite addressed crucial issues at CPHI Barcelona this year, such as supply chain security and dual-continent supply trends, as well as challenges in meeting market demand for advanced bioprocessing materials.

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.

The unrelenting surge in market demand for bioprocessing materials was another central focus, aligning with the industry’s continued expansion. Purolite’s commitment to meeting this demand and continuously elevating our product offerings affirms our dedication to the evolving needs of the biopharma sector.

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, emphasizing the demand for advanced solutions within the bioprocessing sphere.

Felix Solamo, Senior Global Director, Field Applications Scientist from Purolite

ACCORDING TO TJOAPACK

Supply chain security and how to implement it

Pharmaceutical packaging and supply chain security were at the forefront of discussions at CPHI Barcelona 2023 this year, 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 recognized the urgent need to enhance packaging solutions, not only for safety and sustainability but also to bolster supply chain security.

“Reflecting on the learnings of 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, serialization, 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”.

Marcelo Cruz, VP Business Development & Marketing

ACCORDING TO RECIPHARM

In 2023, the pharmaceutical industry faced several key challenges, including a shift in sterile capacity demand.

There is now considerable market demand for sterile capacity worldwide nd we can therefore expect CDMOs to continue investing in capabilities around liquid aseptic filling to serve these geographies.

Pharmaceutical companies are also moving towards innovative technologies and processes to stay competitive. This includes pre-filled syringes, which offer advantages such as dose accuracy, ease of use and reduced risks to patients. The adoption of blow-fill-seal (BFS) technology for biologics is also gaining interest as it provides a cost-efficient aseptic processing method.

Additionally, the rising interest in lyophilisation techniques presents pharmaceutical companies with an opportunity to overcome the challenge of biologic instability, extending the shelf life of biologic products and eliminating the need for cold-chain requirements. Companies can also increase access to underserved populations by offering lyophilisation capabilities to different geographies with high market demand for sterile capacity, such as locations across Europe and Africa.

By adopting these innovative technologies and processes, pharma can better prioritise patient centricity and safety, enhancing biologics capabilities into 2024 and beyond.

AS PER AES CLEAN TECHNOLOGY

The global advanced therapy medicinal products (ATMP) market was valued at $8.4 billion in 2022 and is expected to be worth $20.63 billion by 2031, growing at a compound annual growth rate of 10.5% over the forecast period ^[1].

ATMP modalities rely on the use of parenteral methods of delivery due to their sensitivity. Exposure to harsh conditions such as those found within the gastrointestinal tract could lead to degradation and loss of therapeutic activity. These products must therefore be produced in a sterile environment to assure
patient safety.

Sourcing sterile manufacturing capacity can be complex, and as ATMP demand increases, challenges arise in constructing or expanding a suitable cleanroom facility. Traditionally, “stick-built” cleanroom systems were defined, designed and built with long project timelines and unpredictable costs. Lacking flexibility and relying on out-of-date technology, these facilities were built using conventional construction materials such as gypsum-based drywall.

Improving upon “stick-built” systems, modular cleanroom design uses flexible and fit-for-purpose solutions with pre-fabricated components that can be seamlessly assembled on-site under clean conditions. This pre-manufacturing of materials significantly accelerates project timelines and reduces costs. Fostering sterility, reproducibility, and compliance, the modular cleanroom space assures ATMP products are made efficiently and safely, in line with the current good manufacturing practice guidelines. Moving into 2024, modular cleanroom solutions will continue to lay the foundation for delivering life-saving ATMPs faster and more cost-efficiently while reducing risk and increasing compliance.

Grant Merrill, Chief Commercial Officer

ACCORDING TO CHARGEPOINT

Over the last 12 months, there has been a shift in the pharmaceutical industry to personalised solutions, such as, advanced therapy medicinal products (ATMPs). This growing interest is due to their promise as treatments for rare disease indications. As we move into 2024, the growing development of novel ATMPs is expected to continue.

However, due to the small populations and diverse needs of rare disease patients, manufacturing of ATMPs diverges from traditional large scale-production, requiring small and flexible batch approaches. To effectively navigate these changing needs, a seamless manufacturing, handling and transfer solution is essential. As these products often rely on parenteral methods of administration, assuring sterility is also important for patient safety.

Instilling adaptability into manufacturing lines, and providing containment for sterile integrity, organisations are turning to single-use technology (SUT). Disposed of after use, SUT can be seamlessly integrated into current manufacturing operations. Producing a flexible solution to easily switch between batch needs, SUT also mitigates the need for validated cleaning methods between batch changes, streamlining the production of essential ATMP treatments.

With increasing interest in ATMP solutions, the demand for SUT will continue to grow, becoming an integral manufacturing solution and aiding the production of personalised treatments to meet patient needs.

Ben Wylie, Head of Product Management at ChargePoint Technology

There is, as we can see, a tremendous commotion taking place in terms of innovation in serialization, technologies concerning anti-counterfeiting technologies, single-use technology that mitigates the need for validated cleaning methods between batch changes, a sterile environment so as to assure the safety of patients, etc. All we can say is that it is imperative to ensure that fast-paced utilization of drugs can only be possible when it reaches the right hands at the right time, and this is possible when all angles that concern the supply chain work at their finest.