Contract Development & Manufacturing in Pharmaceuticals: The Difference Between Good & Great

24 July 2020

FiercePharma

The increasing outsourcing trend by small and large pharmaceutical companies represents a promising opportunity for Contract Development and Manufacturing Organizations (CDMOs). As pharma shifts its focus to more research and development and less in-house manufacturing, CDMOs are well positioned to fill the gap between their clients and the patient.

“We believe that we have a moral mission to help develop, manufacture, and deliver life-saving drug substances and products to patients that need them.” – Dr. Tae Han Kim, CEO of Samsung Biologics

When entering into a partnership with a CDMO—quality, total cost of ownership, flexibility, capacity, and agility are critical success factors that are required to create a true partnership beyond a transaction.

“At Samsung Biologics, we consider quality as an enabler. Being good at quality is not enough. Quality is an element of who we are, how we operate, and what we deliver. Delivering beyond expectations is what we do every day. It starts with everyone at Samsung Biologics and ends in the patient’s hands.” – Sam MacHour, Chief Quality Officer at Samsung Biologics

In less than five years of manufacturing track records, Samsung Biologics was successfully inspected by regulatory authorities more than 30 times and received more than 50 drug approvals.

The company is focused on providing the highest quality development, manufacturing, and laboratory testing in the world, and continues to rapidly evolve with the changing demands of the biopharma industry by implementing the latest market innovations including N-1 perfusion and single-use technologies. This commitment to quality, efficiency, and reliability has made Samsung Biologics a winner of the annual CMO Leadership Award for seven consecutive years. 

With its 21st century state-of-the-art facilities, Samsung Biologics is a fully integrated CDMO committed to end-to-end partnership ranging from development to client-centric manufacturing solutions. 

Business Evolution: From CMO to CDO and Beyond

Samsung Biologics was founded in 2011 as a Contract Manufacturing Organization (CMO). Since then, the company has established solid ground as a reputable CMO by building three manufacturing plants by 2017 that house a total capacity of 364,000L of mammalian cell culture, offering the industry’s largest antibody manufacturing capability from a single site. 

With scales ranging from 1KL and 5KL to 15KL, Samsung Biologics can cater to the diverse needs of its clients. The company continues to invest in its facilities in many areas. In addition to upgrading its DS facility with the addition of two smaller scale, 1KL single-use bioreactors, the company recently announced a plan to expand its DP capabilities by adding two larger lyophilizers and a flexible filling line.

In 2018, responding to increased demand for early phase of drug development services, the company expanded its capability as a Contract Development Organization (CDO). Since then, Samsung’s CDO business has seen significant growth, contracting over 50 projects with both local and global clients. To better support its global customers and partners, Samsung Biologics plans to create a dedicated CDO R&D Center in San Francisco, California. 

Samsung Biologics has a notably fast development timeline, offering cell line development to DS manufacturing in nine months, and cell line development to DP manufacturing in 10.5 months. The integrated development and manufacturing process offers clients a seamless, efficient experience at a competitive price. The company has also introduced an internally developed, high-performing proprietary cell line giving clients increased partnership value.

"Through a partnership with Samsung Biologics, biotech companies not only benefit from faster timelines and high-quality products, but they can also concentrate on discovery, a core aspect of their business." – Dr. Tae Han Kim, CEO of Samsung Biologics

Expanded CRO Portfolio to Better Serve Clients

Samsung Biologics recently entered the Contract Research Organization (CRO) market with the launch of its Biosafety Testing Services (BTS). The company intends to occupy more of that space as a natural extension of its business spectrum, with the goal to become a comprehensive end-to-end service provider from CDO to CMO to CRO. 

Clients will benefit from this all-in-one approach, as no extra effort will need to be expended to outsource different aspects of the process. Not only does this save partners time when researching CDMO (or/and CRO) options, but once trust and reliability have been established, both parties can work more effectively on extending the relationship into the wider business spectrum.

“Pharmaceutical companies don’t typically look for one-off services from a CDMO – they want to establish trusted, successful long-term partnerships with end-to-end support.” – Kyoung Lim, Senior Director of Supply Chain Management at Samsung Biologics

Innovation and Agility Built into Samsung Biologics DNA

Samsung Biologics’ growth and evolution over the last decade have demonstrated its remarkable business agility and ability to rapidly scale without sacrificing its commitment to quality and client satisfaction. Moreover, with recent challenges and travel restrictions amid COVID-19, the company quickly responded to enable client services through virtual inspections, reviews, exhibitions, and more. 

Clients benefit from Samsung Biologics’ adaptability and innovation when partnering with the company as their services are designed to offer the latest technological advances to the customers directly. Because the company is used to adapting quickly to industry demands and changing global conditions, their experts can support a broad range of needs from collaborative novel drug development to efficient contract manufacturing partnerships.

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