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THE FUTURE OF BIOMANUFACTURING

Evolution Global’s ongoing BioManufacturing series will provide an exclusive, in-depth analysis of key trends that will shape the future of biologic drug development in the coming years and decades.

By exploring the history of the BioManufacturing market from conception to present day and by analysing both past and ongoing key trends, we will predict what the future of the industry is likely to hold.

This page serves as an overview for The Future of BioManufacturing, providing historical context and an outline of key trends that Evolution Global will elaborate on throughout the series.

DEVELOPMENT PIPELINE

Since its inception in the 1980s-1990s, the field of biologics has developed from being a relative rarity in the human pharmaceutical market to one that, by the beginning of the next decade, will more than likely equal new molecular entities (NMEs) in terms of generating revenue for the pharmaceutical industry.

 MARKET SHARE

IN THE PIPELINE

This change has been driven in part by the fact that the potential for clinical development success for biologics is superior to new NMEs, as highlighted by the table below.

PRECLINICALPHASE IPHASE IIPHASE IIIREGISTRATION
BIOLOGIC12%17%27%58%82%
NME2%4%9%44%72%

Table 1: Percentage likelihood of successful transition to next phase of development

As Biologics have progressed clinically, the category has broadened to include a number of the therapeutic options such as Cell Therapy, Antibody Drug Conjugates (ADCs) and Cancer Vaccines. The chart below outlines the breakdown of Biologics currently in development.

KEY PRODUCTION TRENDS

As novel types of Biologics have been developed, changes in BioManufacturing approaches have been running in parallel with the intention of maximising yield and/or lowering production costs.

Evolution Global have identified and outlined 8 key production trends below, and Evolution Director Dr. Frank Rinaldi will publish a dedicated analysis of each key production trend as we build towards a detailed vision for the future of biomanufacturing.

DISPOSABLE MANUFACTURING TECHNOLOGY

Since their initial development 20 years ago, single-use systems are being increasingly used in almost all stages of biomanufacturing processes, including upstream, downstream, fill/finish operations and sensors.

MODULAR FACTORIES

An extension development of single use technology coupled to open automation, centralized monitoring and control system to optimise bioprocessing in real-time, is the intention is to create factories that can manufacture multiple products at a single site in a modular manner.

REDUCTION IN MARKET SCALE QUANTITIES

Many novel treatments are being targeted towards orphan indications and/or conditions which offer a personalised medicine approach, resulting in a reduction in the manufacturing scale required. For therapies involving autologous biologics, the challenge is not one of scale-up but rather scale-out.

PERFUSION CULTURE

Through the use of Perfusion technologies cell densities up to 100 million/mL can be attained, correlating with higher product yields. Product can be removed within days of expression, significantly faster than fed-batch bioreactors which can take up to 2–3 weeks.

CELL LINE ENGINEERING

The productivity of protein therapeutics has increased by nearly two orders of magnitude in the past two decades. Due to recent advances in genomics and the development of genome editing tools, it is likely that we will see a transformation of cell line development in the near future.

DOWNSTREAM PROCESSING

The success of increased yields has resulted in a serious bottleneck in capacity and overall production due to downstream processing. This is an issue that is of particular significance for Contract Development & Manufacturing Organisations.

IN SILICO MODELLING

Data-driven high performance computing enables bioprocess multi-scenario simulation, involving mechanistic network models of common host organisms to design optimal processes. The intention is to create, prior to physical manufacturing, an overarching biomanufacturing process that is most likely to lead optimal production.

AUTOMATED CLOSED SYSTEMS FOR CELL & GENE THERAPY PROCESSES

Automation is an effective means to reduce manufacturing costs and provide quality assurance.

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