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Bringing flexible solutions to champion shared commitment to saving lives
How Samsung Biologics has leveraged flexibility
to build trust and achieve mutual goals
Mary Cromwell, Chief Technical Officer at Allakos
Scientist-to-scientist trust sprouts when they share goals, grows as they work to solve problems, and blossoms as their intangible efforts bear tangible outcomes. The one-team rapport between drug developers and their partner empowers the team to overcome challenges and move onto the next stage of a project in time.
Partnership rooted in constructive discussion is key to unlocking the therapeutic potential of a drug. Committed to developing more accessible biologics for inflammatory diseases, Allakos has forged such a partnership with a global contract development and manufacturing organization (CDMO) offering flexibility and has advanced its molecules to Investigational New Drug (IND) approval and beyond.
“We were highly confident that with Samsung Biologics we could meet our timelines to start clinical trials for two different formulations of the same product,” said Mary Cromwell, Chief Technical Officer at Allakos. “[Overcoming each project challenge,] I was overjoyed because Samsung was taking a risk and was able to meet our needs with the quality we expected.”
Striding on the path to IND as one team with a sense of unity
Allakos is a clinical-stage biotechnology company committed to finding cures for unmet areas of immune diseases, part of which have been reported to affect about one-fifth of the world population during a lifetime according to a study. The California-based biotech company is developing a Siglec-6 directed agonist monoclonal antibody (AK006) that suppresses and even kills targeted mast cells inducing allergic inflammation in humans.
With a goal to achieve both speed and quality for its project to find cures for mast cell diseases where less than 10% of patients are on biologics, Allakos has partnered with Samsung Biologics to expedite the development of AK006 – moving it quickly from cell line development, to IND approvals, then finally into human trials.
Advancing the route to IND per a desired timeline required scientists of both teams to embrace a shared understanding of goals, risks, and challenges, ultimately trusting one another through candid discussions. Such trust began to emerge from the beginning of the partnership and grew stronger as it progressed, eventually driving the team to overcome the time-sensitive formulation challenge.
To increase dose quality and patient convenience in clinical trials post IND, Allakos needed Samsung Biologics to increase the target concentration level by 300%, initially from 50 mg/ml to 150 mg/ml. By adopting the client’s scientific expertise, the global CDMO developed an agile method outside the rim of its platform formulation. Aligned on goals of bringing high-quality doses to patients in future trials after passing through the last door before IND submission, the Allakos-Samsung Biologics team were able to remodel their formulation strategy together, implemented it, and finally managed to achieve the target concentration level in a condensed timeline.
"The ability of scientists to have candid conversations with each other is critical to quickly drive projects forward and develop the right technical solutions," said Cromwell. "We had a great sense of unity with Samsung Biologics. They understood our challenges and worked alongside us to overcome any hurdles. This trust helped us advance the project much quicker, ultimately leading to development of the appropriate technical solutions we needed.”
A sense of unity among scientists of both teams helped facilitate constructive debates, morphing each other’s arguments into a concerted solution.
“Honest exchange of ideas and shared goals enabled the growth of a true partnership between Allakos and our development teams,” said Derrick Katayama, a lead formulation scientist at Samsung Biologics. “Identifying technical strategies to achieve a higher concentration level in a short timeline was definitely challenging. However, leveraging resources from both parties enabled a successful development program. It was a wonderful and enriching experience working with all members of the Allakos project team.”
Flexibility for CDMOs means assessing issues from the client’s perspective, leveraging every resource to find solutions, and executing joint solutions in time to support the client’s commitment to patients.
“[The way Allakos and Samsung Biologics resolved the formulation challenge was] an excellent example of the two companies working closely together for a shared outcome of developing the increased concentration that goes into people,” said Cromwell.
Trusted CDMO partner offering flexibility to solve problems post IND
Allakos earned IND approvals for both intravenous and subcutaneous formulations of AK006 in time and asked its CDMO partner to help accelerate the start of phase I clinical trials through CGMP drug substance (DS) and drug product manufacturing as well as regulatory support.
During manufacturing of the first DS batch round, dissolved oxygen control issues occurred within bioreactors, which if not resolved would have resulted in the need of a larger number of manufacturing runs and potentially impacting the quality. The Allakos-Samsung Biologics partnership took advantage of the mutual trust and flexibility developed from the beginning to resolve issues in time.
“We had a challenge in our first manufacturing campaign and thus wanted to have our people here on site who could provide technical input if we ran into the same challenges,” said Cromwell. “And Samsung Biologics agreed to having us here over the Lunar New Year holidays, a time that is not easy to host people. This showed a lot of willingness and flexibility from Samsung Biologics.”
Hosting a team of Allakos scientists on Samsung Biologics’ manufacturing facility enabled spontaneous, synergetic exchanges of ideas between the two and eventually led to the right solution at the right time. As a result, not only were the issues resolved, but the Allakos-Samsung Biologics team also managed to increase the amount of overall DS yield for the second and third round of CGMP DS manufacturing by 10% and 46%, respectively, compared to the first round.
Recently, Allakos announced positive results from its ongoing phase I trial of AK006, which demonstrated high receptor occupancy on mast cells and a favorable safety profile.
“This is truly how we see the partnership advance in terms of how we can continue to work together to make sure that quality aspects are there as we produce more materials; how we can continue to improve the process for higher yield,” said Cromwell. “The trust we built from a shared understanding of the risk, goal, and challenge has been the great foundation of our successful advancement of AK006 so far.”
The embodiment of trust in a CDMO partnership invigorates the drug-development journey toward a united cause – imbuing patients with hope for a healthier future. Samsung Biologics champions the cause and prepares to offer flexibility to its clients when needed. The ultimate goal the global CDMO shares with biotechnology and pharmaceutical companies is to expedite the life-essential drug development and manufacturing process without compromising quality. Achieving this goal is only possible through a trusted relationship with clients, and all staff at Samsung Biologics work to bring the possibility into reality every day.
For more information on our end-to-end drug development services, please reach out to our experts at contact us.
Related contents
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Samsung BIOInsight Forging a trusted partnership in end-to-end drug development
How Samsung Biologics has leveraged flexibility
to build trust and achieve mutual goals
Mary Cromwell, Chief Technical Officer at Allakos
Scientist-to-scientist trust sprouts when they share goals, grows as they work to solve problems, and blossoms as their intangible efforts bear tangible outcomes. The one-team rapport between drug developers and their partner empowers the team to overcome challenges and move onto the next stage of a project in time.
Partnership rooted in constructive discussion is key to unlocking the therapeutic potential of a drug. Committed to developing more accessible biologics for inflammatory diseases, Allakos has forged such a partnership with a global contract development and manufacturing organization (CDMO) offering flexibility and has advanced its molecules to Investigational New Drug (IND) approval and beyond.
“We were highly confident that with Samsung Biologics we could meet our timelines to start clinical trials for two different formulations of the same product,” said Mary Cromwell, Chief Technical Officer at Allakos. “[Overcoming each project challenge,] I was overjoyed because Samsung was taking a risk and was able to meet our needs with the quality we expected.”
Striding on the path to IND as one team with a sense of unity
Allakos is a clinical-stage biotechnology company committed to finding cures for unmet areas of immune diseases, part of which have been reported to affect about one-fifth of the world population during a lifetime according to a study. The California-based biotech company is developing a Siglec-6 directed agonist monoclonal antibody (AK006) that suppresses and even kills targeted mast cells inducing allergic inflammation in humans.
With a goal to achieve both speed and quality for its project to find cures for mast cell diseases where less than 10% of patients are on biologics, Allakos has partnered with Samsung Biologics to expedite the development of AK006 – moving it quickly from cell line development, to IND approvals, then finally into human trials.
Advancing the route to IND per a desired timeline required scientists of both teams to embrace a shared understanding of goals, risks, and challenges, ultimately trusting one another through candid discussions. Such trust began to emerge from the beginning of the partnership and grew stronger as it progressed, eventually driving the team to overcome the time-sensitive formulation challenge.
To increase dose quality and patient convenience in clinical trials post IND, Allakos needed Samsung Biologics to increase the target concentration level by 300%, initially from 50 mg/ml to 150 mg/ml. By adopting the client’s scientific expertise, the global CDMO developed an agile method outside the rim of its platform formulation. Aligned on goals of bringing high-quality doses to patients in future trials after passing through the last door before IND submission, the Allakos-Samsung Biologics team were able to remodel their formulation strategy together, implemented it, and finally managed to achieve the target concentration level in a condensed timeline.
"The ability of scientists to have candid conversations with each other is critical to quickly drive projects forward and develop the right technical solutions," said Cromwell. "We had a great sense of unity with Samsung Biologics. They understood our challenges and worked alongside us to overcome any hurdles. This trust helped us advance the project much quicker, ultimately leading to development of the appropriate technical solutions we needed.”
A sense of unity among scientists of both teams helped facilitate constructive debates, morphing each other’s arguments into a concerted solution.
“Honest exchange of ideas and shared goals enabled the growth of a true partnership between Allakos and our development teams,” said Derrick Katayama, a lead formulation scientist at Samsung Biologics. “Identifying technical strategies to achieve a higher concentration level in a short timeline was definitely challenging. However, leveraging resources from both parties enabled a successful development program. It was a wonderful and enriching experience working with all members of the Allakos project team.”
Flexibility for CDMOs means assessing issues from the client’s perspective, leveraging every resource to find solutions, and executing joint solutions in time to support the client’s commitment to patients.
“[The way Allakos and Samsung Biologics resolved the formulation challenge was] an excellent example of the two companies working closely together for a shared outcome of developing the increased concentration that goes into people,” said Cromwell.
Trusted CDMO partner offering flexibility to solve problems post IND
Allakos earned IND approvals for both intravenous and subcutaneous formulations of AK006 in time and asked its CDMO partner to help accelerate the start of phase I clinical trials through CGMP drug substance (DS) and drug product manufacturing as well as regulatory support.
During manufacturing of the first DS batch round, dissolved oxygen control issues occurred within bioreactors, which if not resolved would have resulted in the need of a larger number of manufacturing runs and potentially impacting the quality. The Allakos-Samsung Biologics partnership took advantage of the mutual trust and flexibility developed from the beginning to resolve issues in time.
“We had a challenge in our first manufacturing campaign and thus wanted to have our people here on site who could provide technical input if we ran into the same challenges,” said Cromwell. “And Samsung Biologics agreed to having us here over the Lunar New Year holidays, a time that is not easy to host people. This showed a lot of willingness and flexibility from Samsung Biologics.”
Hosting a team of Allakos scientists on Samsung Biologics’ manufacturing facility enabled spontaneous, synergetic exchanges of ideas between the two and eventually led to the right solution at the right time. As a result, not only were the issues resolved, but the Allakos-Samsung Biologics team also managed to increase the amount of overall DS yield for the second and third round of CGMP DS manufacturing by 10% and 46%, respectively, compared to the first round.
Recently, Allakos announced positive results from its ongoing phase I trial of AK006, which demonstrated high receptor occupancy on mast cells and a favorable safety profile.
“This is truly how we see the partnership advance in terms of how we can continue to work together to make sure that quality aspects are there as we produce more materials; how we can continue to improve the process for higher yield,” said Cromwell. “The trust we built from a shared understanding of the risk, goal, and challenge has been the great foundation of our successful advancement of AK006 so far.”
The embodiment of trust in a CDMO partnership invigorates the drug-development journey toward a united cause – imbuing patients with hope for a healthier future. Samsung Biologics champions the cause and prepares to offer flexibility to its clients when needed. The ultimate goal the global CDMO shares with biotechnology and pharmaceutical companies is to expedite the life-essential drug development and manufacturing process without compromising quality. Achieving this goal is only possible through a trusted relationship with clients, and all staff at Samsung Biologics work to bring the possibility into reality every day.
For more information on our end-to-end drug development services, please reach out to our experts at contact us.
Related contents
Our Services Development Services
Samsung BIOInsight Forging a trusted partnership in end-to-end drug development