iSpeak Blog

Trends and Innovations in Bio-Manufacturing. Global Outlook on the Future of Biopharmaceuticals.

Richard Denk
Antonio R. Moreira, PhD
Ryan Paul Mazur
Source: Aseptic Technologies AT

The outlook for the biopharmaceutical market is promising, with expectations that the market will double in the next 10 years, resulting in new therapies and advances in biopharmaceutical manufacturing. This doesn't sound like much at first, but if you consider how the market has developed over the last 20 years, a doubling in the next 10 years is very significant.

What is the composition of this growth and what are the innovations of the next 10 years? On the one hand, biosimilars will be a growth driver. Many patents are expiring: biosimilars or biobetters will develop from this and manufacturing will be distributed globally. This also makes biosimilars or biobetters possible for a larger population.

Another factor will be personalized medicine such as cell and gene technology. In no other sector of the pharmaceutical industry is there currently more research and development than in this area. More than 2,000 global start-ups, universities, and global pharmaceutical manufacturers are involved in the development of these new technologies. The first products have already been successfully approved by the authorities and there should be at least 10-15 new approvals every year.

Another innovative sector is combination products such as antibody drug conjugates (ADCs). These have received a new boost in recent years and will shape the market in the next 10 years.

Exciting times are coming for the pharmaceutical industry and its suppliers, with new opportunities to treat and cure diseases. New therapies require new innovations in manufacturing, with modular and more flexible manufacturing as well as global and patient-centered manufacturing.

With the emergence of new innovations and technologies for the manufacturing of new therapies and modalities, current engineers, scientists, researchers, clinicians, regulatory and quality professionals, etc., are being exposed to cutting-edge technology that will shape the future of the industry. Emerging leaders in the field of biopharmaceutical manufacturing are poised to have a profound impact on the global outlook for the industry's future.

These individuals, often characterized by their visionary thinking, entrepreneurial spirit, and commitment to innovation, are driving forward transformative advancements that promise to revolutionize the way medicines are developed, produced, and distributed. With a keen focus on leveraging cutting-edge technologies such as artificial intelligence, machine learning, and automation, these leaders are streamlining processes, enhancing product quality, and accelerating time to market.

Trends and Innovations in Bio-Manufacturing. Global Outlook on the Future of Biopharmaceuticals.

Moreover, their emphasis on sustainability and environmental stewardship is reshaping manufacturing practices and fostering the development of greener and more eco-friendly production methods. As these emerging leaders continue to rise, their collective efforts hold the potential to usher in a new era of biopharmaceutical manufacturing, marked by increased efficiency, accessibility, and affordability, ultimately benefiting patients worldwide.

Track #4 of the 2024 ISPE Biotechnology Conference features expert-curated content on novel technology innovations in the advanced manufacturing of pharmaceuticals. These innovations include the integration of artificial intelligence (AI) and machine learning (ML) algorithms to optimize drug discovery, predict drug behavior, and accelerate clinical trials. Additionally, advancements in automation and robotics are enhancing manufacturing efficiency, reducing human error, and increasing throughput.

The modalities of the future will require factories and production spaces to accommodate emerging technologies, processes, and drug product delivery and distribution to patients globally. Robert Dream, PE, CPIP, PhD, Managing Director of HDR Company, will outline a holistic vision for the “Factory of the Future”. His session will demonstrate how manufacturers shall adopt strategic planning, effective leadership, enhanced employee training, advanced robust IT infrastructure, and stringent regulatory oversight to pursue the vision of future biopharmaceutical production centers.

Future modalities will also require innovations to legacy processes such as aseptic filling while remaining compliant with new and enhanced regulatory requirements such as EU Annex 1. Julian Peterson, Head of Business Development and Product Management, Groninger & Co GmbH, will present on aseptic filling in a quickly advancing technology, gloveless isolators. He will highlight how gloveless isolators can enhance the speed of advanced therapy medicinal products (ATMPs) reaching patients in a decentralized, local production facility. His session will provide guidance on how gloveless fill/finish systems will be vital for the future of ATMP manufacturing and maintaining regulatory compliance.

While new emerging technologies will allow for revolutionary drug discoveries and the emergence of new disease targets, the cost of goods (COGS) to manufacture advanced cell and gene therapies could rise significantly. Komal Hatti, Director, Process Architect, IPS, and Zhimei Du, Vice President, Landmark Bio, will guide attendees on how end-to-end automation and simulation-based facility design will streamline manufacturing processes of autologous chimeric antigen receptor (CAR) T-cell therapies to lower manufacturing costs. They will present a roadmap on the design and implementation of a remote-control technology platform that addressed the challenges from patient material collection to final delivery at clinical sites while ensuring consistent quality and reducing operational inefficiencies.

The future of biopharmaceutical production will require an innovative and flexible approach to inactive eukaryotic, microbial, and viral organisms in a continuous operation to advance global vaccine production. Daniel Becker, Head of Business Development INACTIVATE, KyooBe Tech GmbH, will present the advantages and use cases of low-energy electron irradiation (LEEI) technology for liquid suspensions. He will demonstrate how LEEI technology can have a far-reaching impact not only on vaccine production but other aspects of the industry, including blood products and the treatment of infectious liquid waste.

Artificial Intelligence (AI) has evolved significantly over the past decade and is poised to be one of the most crucial technologies in the future of pharmaceutical production. David C. O’Connell, Project Manager, Verista, Inc., will discuss how AI is expanding into various aspects of pharmaceutical manufacturing and regulatory compliance. He will present real-life case studies on the successful implementation of AI for compliance such as the creation of the Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Standard Operating Procedures (SOPs) documentation.

Attendees will have the opportunity to hear and interact directly with future emerging leaders that will play a vital role in the future of the pharmaceutical industry. The session “Global Strategy for a Pandemic Vaccine Supply” will feature a group of students from University of Maryland, Baltimore County (UMBC), who were selected as the winners of a capstone project under the guidance of Antonio R. Moreira, PhD, UMBC, and Richard Denk, SKAN AG. The session will highlight the solution framework that was created by the student group on how to deliver vaccines in a rapid timeframe to the global population.

Overall, this entire track has been crafted to showcase novel technologies and the role they will play in the development of promising transformative treatments for a myriad of diseases. Attend the 2024 ISPE Biotechnology Conference on 17-18 June 2024 to explore how pharmaceutical manufacturing will continue to be fueled by innovation and collaboration, ensuring a promising future for manufacturing that will offer hope and assurance for improved patient outcomes and enhanced healthcare worldwide.

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