Partnerships for Success

Partnerships for Success

June 25, 2024PAO-06-24-CL-08

Trust empowers a CDMO and its partners to grow together and achieve shared goals. 

Key Takeaways: 

  • Trust forges long-lasting relationships between a CDMO and its partners based on transparency and flexibility 

  • A CDMO should become a trusted partner to its clients to help fulfill their commitment to patients 

  • Samsung Biologics adopts its own ways to achieve excellence, build trust, and ensure client satisfaction

Samsung Biologics, a global leading contract development and manufacturing organization (CDMO), has expanded its capacity more than 20 times within just over a decade. Behind its unprecedented business growth strategy was a mission to become a trusted partner to those developing critical and life-saving drugs worldwide. Earning trust from global biopharmaceutical companies wasn’t easy. The CDMO needed to steadfastly nurture service flexibility and a quality mindset, as well as continuously enhance its operational excellence. 

Since its founding, Samsung Biologics has cultivated a tenure of trusted partnerships with more than a hundred global drug developers. From late drug discovery to aseptic fill/finish and final on-time delivery of quality biomedicines wherever needed, the global CDMO has established a track record of delivering on its promises to its partners. And the record keeps piling up to this moment, in tandem with the success of its partners. 

Trust in partnerships between CDMOs and drug developers is irreplaceable. It is the prerequisite for any CDMOs to possess a client-centric mindset and for drug developers to leverage all of their resources to bring innovative drugs to patients, making the CDMO selection process one of the most critical steps.

For Samsung Biologics, trust is the primary value that drives the company to enhance its service excellence and transparency in order to advance its partners’ mission to patients onto the next stage. 

Partnership with a Trusted CDMO Means a Step Forward to Project Success

In 2021, Bolt Biotherapeutics, a California-based biotech company, was looking for a CDMO partner it could count on to create a drug development solution. Committed to developing a myeloid-modulating agonist antibody to battle cancers, Bolt partnered with Samsung Biologics to obtain investigational new drug (IND) approval for the agonist antibody within an expedited timeline. The Bolt and Samsung teams brought their expertise together to move forward, united by the belief that every second counts for patients waiting for a cure. 

Working as one team, they developed an agile solution to keep the project on track and, in the end, earned IND approval per Bolt’s desired schedule. “We invested so much effort and passion into the project. And getting to the point of actually having the high-quality drug in a vial ready to administer to patients brings us hope that one day, our drugs that Samsung is manufacturing for us will save lives,” said a senior executive at Bolt. 

The trust in partnership extends beyond this first goal — Samsung Biologics is committed to enhancing its service flexibility through expedited capacity expansion, ensuring that it will continue to support Bolt’s pioneering drug if the clinical trials are successful.

“Transparency in a partnership is extremely important because it allows us to have confidence in what we are receiving from our CDMO partner,” said the senior executive. “Our earned confidence in Samsung Biologics’ end-to-end drug development service enabled us to take full advantage of its quality-centric, speedy execution and readily available bioreactors of various sizes to achieve our project goal." 

“The way Samsung is building new plants and adding capacity in the future gives us the confidence that a year or two from now, there will be adequate capacity, if our project is successful, for us to continue to work together.”

When a CDMO and its partner trust each other, the partnership becomes driven to generate tangible, synergetic actions — such as seamless communication and proactive sharing of knowledge from both sides — and increases the viability of an intricate drug development project. 

In 2022, Aronora, an Oregon-based biotech company, needed cell line development support with its efforts to craft a lifeline for people battling blood clotting disorders. The biotech partnered with Samsung Biologics, which has a proven track record of developing high-quality cell lines and efficiently moving a promising molecule out of R&D into manufacturing. Samsung Biologics’ blend of streamlined processes, end-to-end services, and dedication to excellence in its science, operations, and client project management allowed the CDMO to help Aronora develop a cell line with a titer nearly tenfold higher than its original cell line. 

The Samsung Biologics team “instantly understood our specific needs and were wholeheartedly collaborative throughout the entire process,” said a director of clinical operations at Aronora. “As a small company, we have really benefited and learned a lot about the entire process as opposed to just looking at it piece by piece.” 

On the other side of the successful cell line development project was close-knit communication — that facilitated one-team collaboration between teams of Aronora and Samsung Biologics. 

“The project managers at Samsung Biologics were very proactive with communication and responsive to our requests,” said the clinical operations director. “They always followed up to ensure that nothing fell through the cracks".

“We are truly in good hands with Samsung.”

In a trusted partnership, open communication and shared goals bind a CDMO to its partner’s vision. For the CDMO, this starts with putting the client first and staying in step with what the partner needs now and will need down the road. Then, it's about getting the day-to-day right — smooth operations where clear communication and data handling mean fewer mix-ups and more forward momentum. Quality cannot be an afterthought: It's always kept in focus, making sure every step moves things ahead to prepare for what regulators will demand. Of course, none of this works without the right people, who keep learning and growing and are ready to tackle any challenge thrown their way. This solid base enables drug developers, such as Bolt and Aronora, to stay focused on the big picture: researching, funding, and guiding their product through the regulatory process while holding firm trust that the CDMO is handling the rest of the development and manufacturing considerations.

The “Samsung Biologics Way” to Ensure Client Satisfaction

Whether a startup biotech or a big pharma company, our clients place patients first before any business interests. Clients often ask us to accommodate their challenging needs, sometimes at the very last minute. We appreciate these requests because they demonstrate our clients' trust in our execution capabilities and flexibility.

Developing and maintaining trust with clients isn’t easy. However, we have been able to do so by adopting our own four pillars of excellence — Client Excellence, Operational Excellence, Quality Excellence, and People Excellence — since our founding in 2011. Below is how we define each:

  • Client Excellence: Transparency that facilitates proactive knowledge sharing between CDMOs and their partners is the backbone of client excellence. Focusing daily operations and business development plans on addressing client needs is what CDMOs need to do for client success.

  • Operational Excellence: A practiced reality involving an ongoing commitment to optimizing processes and standardizing systems for efficiency, data integrity, and ultimately client satisfaction. Operational excellence enhances CDMOs’ capability to solve problems, safeguard the drug development life cycle, and help their clients deliver drugs to patients on time. 

  • Quality Excellence: A quality mindset and culture ensure that client programs stay compliant with evolving regulations. The best approach for CDMOs to maintain the necessary compliance is to integrate quality-by-design (QbD) principles from the start. CDMO operations by QbD principles maintain robust data integrity, enable the timely problem-solving of issues — when/if they occur — and thus ultimately help jump regulatory hurdles without delays.

  • People Excellence: With an eye toward the future, CDMOs should invest in ongoing employee development to ensure they are not just ready for today’s challenges but also crafting tomorrow’s innovations.

We understand how committed our clients are to their patients and how critical it is for them to reduce their project completion timelines by even just a few days. Therefore, we recognize the importance of embracing a client-centric mindset and integrating it into our daily operations. This is why we have adopted trust as our primary engine that empowers us to progress our partners’ vision for their business — and mission for their patients.

Our business success translates into client success, and ultimately, into patient well-being. This belief is the foundation of our four pillars of excellence, which we have incorporated into our business plans and operations. While a business-to-business relationship is often seen as transactional, my colleagues and I at Samsung Biologics believe our relationships with global drug developers go beyond mere transactions. This is why we call it a partnership — driven by trust.

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