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.
References
Biopharmaceutical Contract Manufacturing Market by Type of Product, Scale of Operations, Expression System, Company Size, Biologics and Key Geographical Regions – Industry Trends and Global Forecast to 2030 [Internet]. Reportlinker.com. 2021 [cited November 2021]. Available from: https://www.reportlinker.com/p06076408/Biopharmaceutical-Contract-Manufacturing…
This website uses cookies to enable, optimise and analyse site operations, as well as to provide personalised content and allow you to connect to social media. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". Please view our Cookie Policy to learn more about the use of cookies on our website.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Cookie
Description
cookielawinfo-checkbox-advertising-targeting
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".
cookielawinfo-checkbox-analytics
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".
cookielawinfo-checkbox-necessary
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".
PHPSESSID
This cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
zmember_logged
This session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.
Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. These cookies do not store any personal information.
Cookie
Description
cf_ob_info
This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving “Always Online” until the cookie expires.
cf_use_ob
This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving “Always Online” until the cookie expires.
free_subscription_only
This session cookie is served by our membership/subscription system and controls which types of content you are able to access.
ls_smartpush
This cookie is set by Litespeed Server and allows the server to store settings to help improve performance of the site.
one_signal_sdk_db
This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status.
YSC
This cookie is set by Youtube and is used to track the views of embedded videos.
Analytics cookies collect information about your use of the content, and in combination with previously collected information, are used to measure, understand, and report on your usage of this website.
Cookie
Description
bcookie
This cookie is set by LinkedIn. The purpose of the cookie is to enable LinkedIn functionalities on the page.
GPS
This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location
lang
This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc
This cookie is set by LinkedIn and used for routing.
lissc
This cookie is set by LinkedIn share Buttons and ad tags.
vuid
We embed videos from our official Vimeo channel. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. This cookie does not track individuals.
wow.anonymousId
This cookie is set by Spotler and tracks an anonymous visitor ID.
wow.schedule
This cookie is set by Spotler and enables it to track the Load Balance Session Queue.
wow.session
This cookie is set by Spotler to track the Internet Information Services (IIS) session state.
wow.utmvalues
This cookie is set by Spotler and stores the UTM values for the session. UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on.
_ga
This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. It stores information anonymously and assign a randomly generated number to identify unique visitors.
_gat
This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites.
_gid
This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form.
Advertising and targeting cookies help us provide our visitors with relevant ads and marketing campaigns.
Cookie
Description
advanced_ads_browser_width
This cookie is set by Advanced Ads and measures the browser width.
advanced_ads_page_impressions
This cookie is set by Advanced Ads and measures the number of previous page impressions.
advanced_ads_pro_server_info
This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. It is used by cache busting in Advanced Ads Pro when the appropriate visitor conditions are used.
advanced_ads_pro_visitor_referrer
This cookie is set by Advanced Ads and sets the referrer URL.
bscookie
This cookie is a browser ID cookie set by LinkedIn share Buttons and ad tags.
IDE
This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
li_sugr
This cookie is set by LinkedIn and is used for tracking.
UserMatchHistory
This cookie is set by Linkedin and is used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
VISITOR_INFO1_LIVE
This cookie is set by YouTube. Used to track the information of the embedded YouTube videos on a website.
This article outlines something very important, biological drugs can be a lifeline.
Thanks for the article, I learned a lot about the introduction of new drugs to the market