Samsung BioLogics has come a long way in seven years. Having started out as a CMO, the company has grown into an end-to-end service provider with capabilities spanning far beyond manufacturing, enabling it support clients from early-stage development onward.
To reposition itself as a CDMO—a contract, development and manufacturing organization—Samsung BioLogics has built out an end-to-end service featuring capabilities rarely found under one roof. The expanded organization is equipped to help clients with cell line development, quality control, long-term stability studies, commercial-scale manufacturing and many drug product and substance tasks in between.
Importantly, Samsung BioLogics has expanded its service offering without compromising on the quality that established it at the forefront of the contract manufacturing sector. To enter each new service area, Samsung BioLogics has invested in highly-qualified people and cutting-edge equipment, just as it did to get started as a contract manufacturer.
These investments have given Samsung BioLogics a cell line development operation capable of going from DNA sequence to the screening and ranking of subclones in six months. Similarly, the analytics and QC services group has the DNA sequencers, spectrometers and other equipment needed to provide leading services, plus employees with extensive experience of using the technology and meeting the needs of clients.
Taking this approach has enabled Samsung BioLogics to expand into new service areas while maintaining its impeccable regulatory record. Samsung BioLogics has now received 17 approvals from global regulatory agencies, including the FDA, EMA and PMDA. The approvals include drug product clearances from the U.S., European and Japanese agencies.
Samsung BioLogics has achieved these approvals without receiving a single critical observation. The perfect record is particularly impressive given the increasing vigilance of regulatory inspectors, who have refused to approve several manufacturing facilities run by other companies recently.
Maximizing client satisfaction
By evolving into a provider of contract development and manufacturing services for drug substances and products, Samsung BioLogics has equipped itself to maximize client satisfaction and quality excellence.
Typically, biopharma companies are forced to work with multiple service providers to access all of the development and manufacturing support they need. Working with multiple providers creates communication challenges and complicates project management, adding to the already-daunting task of getting a drug to market. At best, this requires a company to commit considerable time and energy to the management of their service providers.
At worst, it delays the progress of new medicines. Each touchpoint between development and manufacturing teams carries risks. Seamless transfers are needed to keep programs moving forward at full pace. The challenge of pulling off such seamless transfers increases inline with the number of organizations involved.
Samsung BioLogics’ end-to-end service offers companies a way to minimize these challenges. Having three mega plants and a comprehensive service suite enables Samsung BioLogics to accelerate time to market to meet clients’ schedules and maximize their satisfaction. When a client needs to scale up, Samsung BioLogics simply moves them to the larger bioreactors it houses at the same site.
This way, a company can work with Samsung BioLogics from when they need preclinical supplies made in 50 liter bioreactors, right up to when they require commercial products made in 15,000 liter bioreactors. As each scaleup step is managed by Samsung BioLogics, the time and labor required for tech transfer and other tasks are reduced considerably. And because Samsung BioLogics is the largest CMO in the world with bioreactors totaling 362,000 liters, clients can always access capacity.
The end-to-end service provided by Samsung BioLogics can benefit all companies but is of particular value to plant-less biotechs. A biotech that chooses to work with Samsung BioLogics at an early stage knows it can rely on the company right up to commercial supply, enabling it to put more time and money into its core task of quickly advancing innovative, life-changing drugs to patients.
In expandi...
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