Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies to accelerate molecules to market.
Biologics – challenges and opportunities
Over the years, the rising popularity of biologics has led to a shift in healthcare. In the last decade alone, the annual number of approvals of biopharmaceuticals by the US Food and Drug Administration (FDA) have steadily risen. In 2019, a total of 28 biopharmaceutical products (including monoclonal antibodies, recombinant proteins and gene therapies) were approved in the US.1
Biologic drug development is a long, complex and expensive process. Some of pharma’s key concerns include the rate of attrition (failure) of pipeline drugs and therapies, prolonged development timelines, complex molecular structures (which demand niche and specialised expertise), not to mention current facility limitations and capacity constraints.1
Biologics’ clear patient benefits
Derived from living cells, biologic drugs are used to treat a broad range of critical diseases like COVID-19 and Alzheimer’s disease. Proving effective with lesser side-effects at treating immune-related diseases including rheumatoid arthritis, psoriasis and Crohn’s Disease, biologics act to interrupt signals and pathways in the immune system and reduce the damage inflicted by these chronic conditions.
Biologics drugs, however, are far from being limited to the treatment of immune-related diseases. Those containing antibody-drug conjugates (ADCs), for example, offer strong and specific binding to the target antigen, thus maximising efficacy and safety, making them desirable candidates for treating target-specific illnesses. According to Bioanalysis, “biologic drugs are at the cutting edge of medical research and have, to some extent, revolutionised cancer treatment and offered hope to patients who have previously had no available treatment options.”2
Given the clear benefits and therapeutic track-record of biologic drugs (target specificity, high efficacy and favourable safety profiles), most industry observers believe the biopharma market is poised for continued and consistent growth over the next decade. According to Roots Analysis, in 2021, 8,000 biological pharmaceutical products were currently under clinical investigation around the world.1,3
It is commonly understood that the longer a biologics development program takes, the more expensive and less competitive it will likely be. The order of market entry also has a significant impact on the market share gained. Industry order of entry market share performance data shows the first and second products to enter the market typically obtain over 70 percent of overall market share. Faster development timelines are therefore key to accelerating the pace to market and achieving return on investment (ROI), but where are the efficiencies to be found?
Trimming timelines with a single cell line platform approach
To shorten investigational new drug (IND) development timelines and gain a more rapid entry into the clinical stage, a fully integrated strategy using the cell line platform approach is proving effective. With molecules developed on a single platform common to cell-line development (CLD) and commercial-scale processing, technology transfer can be considered earlier in the development stage.
Undertaking all these activities at a single site, such as through a CDMO, can further enhance efficiency and minimise risks associated with scale-up and technology transfer later in development and commercialisation, as there may be less of a “facility knowledge gap” between development and commercial teams.
Process platform technology’s big advantage: process confidence
CDMOs in particular are specialising in process platforms for better performance”
A big advantage of taking the process platform approach to CLD is the standardisation and familiarity it brings, which shortens timelines and boosts confidence in both the cell line and its development process. It is also a proven risk management strategy because it is based on an experienced understanding of applying the platform technology in the development process.
CDMOs in particular are specialising in process platforms for better performance, and several offer proprietary technologies that multiply faster, offering better viability and delivering higher yields.
Through a combination of cell line platform and a strong process platform, developers can get access to an expedited process for the development and commercialisation of monoclonal antibodies by increasing the probability of selecting high-producing clones.
Additional efficiency strategies
Strategies for shortening CLD timelines include applying single cell cloning using pools of transfectants directly with a single round of cloning and leveraging high-throughput tools such as 24-deep well plates. Screening clones using a small bioreactor in development is also proving to be an effective efficiency driver – and CDMOs using this approach to accelerate selection are demonstrating the methodology can yield dramatic reductions in CLD timelines.
more than five years ago, 18 months was a rule of thumb timeline for Phase I IND filing… today, 10-12 months is now considered to be an industry standard”
Pharma innovators and their CDMO partners are also leveraging standardised upstream/downstream process (USP/DSP) methodologies for monoclonal antibody production. Following final cell line selection to determine the master cell bank (MCB), evaluations of upstream and downstream process and formulation performance can be conducted in parallel using platform analytics for product testing. This can set the stage for a more efficient current good manufacturing practice (cGMP) product release. Further, a 200L batch of non-GMP material can be processed in parallel to produce an IND-enabling toxicology test and used in later-stage process performance evaluation activities. Similarly, it supports more accurate screening and efficient pilot batch runs. This strategy can also reduce timelines from five months down to two to three months, while maintaining product quality and operational robustness.
Get to IND faster
Just a little more than five years ago, 18 months was a rule of thumb timeline for Phase I IND filing. However today, 10-12 months is now considered to be an industry standard and nine months a benchmark goal for leading biopharmaceutical manufacturers.4 Through the development strategies and platform approaches discussed in this article, developers are gaining ground: shortening timelines and achieving faster paths to clinical trial and approval.
About the author
Seahee Kim PhD has more than 11 years of experience, including in the biopharma industry. She leads the CLD at Samsung Biologics, and successfully developed over 30 CLD projects. Before joining Samsung Biologics in 2017, she was a scientist leading a research team in a biology lab at the Samsung Advanced Institute of Technology, the Republic of Korea, and was responsible for personalised cancer medicine and DNA diagnostics research. She received her PhD degree in Molecular Virology from the Yonsei University, and post-doctoral training in Biochemistry and Molecular Biology at the Penn State University, US.
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Thanks for the article, I learned a lot about the introduction of new drugs to the market