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Wednesday, May 22, 2024

BioDuro-Sundia - A Pioneer in Amorphous Solid Dispersion

BioDuro-Sundia is a global Contract Research, Development, and Manufacturing Organization (CRDMO), partnering with pharmaceutical companies to develop and manufacture lifesaving drug products for millions of patients around the world. The company’s mission is “to be the TRUSTED partner delivering world-class drug discovery, development, and manufacturing services” in order to speed its clients to clinic and market. The company’s legacy as a pioneer in amorphous solid dispersion (ASD) development and GMP contract manufacturing services extends more than 25 years for oral solid dosage (OSD) forms. “Our enabling technologies can screen poorly soluble new chemical entities (NCE’s) to increase solubility and enhance bioavailability when only 100 mg of API is available. We use a specialized integrated approach to assess formulation options starting with in-silico evaluation followed by in-vitro screening combined with in-vivo PK animal model data,” adds Kent Payne, CEO, BioDuro-Sundia. This screening platform, called Solution Engine 2.0, utilizes physical chemistry modeling to screen miscibility coupled with in-vitro solubility evaluation of ASD candidates and two rounds of animal PK data to select the best enabled bio available prototype for further scale-up and development in less than 8 to 12 weeks.

With the backing of Advent International in 2019, BioDuro-Sundia strategically transformed to add scale and capacity in discovery, drug substance, and drug product, making BioDuro-Sundia the preferred global CRDMO partner it is today. “We are recognized for our scientific expertise as well as being a fast and flexible partner to clients ranging from large pharmaceutical brands to small emerging bio-pharmaceutical start-ups. By facilitating successful outcomes with thousands of pharmaceutical companies, we have built a strong reputation for oral solid dosage (OSD) product development services from pre-formulation through clinical and commercial GMP manufacturing,” adds Payne.

Clients come to BioDuro-Sundia for top tier science, high quality, flexibility, and our “Can Do” attitude. Our team delivers quality products on time to clients. In the end, we know our work impacts both our clients and patients. Our team is committed to embark on the next phase of growth as we deliver value to clients across our integrated network.

BioDuro-Sundia is a contract research, development, and manufacturing organization (CRDMO) that has been serving the biotech and pharmaceutical industries for over 27 years. Based in the US and China, the company has a global presence with more than 3,000 employees and 10 global sites across 7 cities. We offer a range of fully integrated services to support our biotech and pharmaceutical partners, from target identification to commercial drug product manufacturing.

With the addition of commercial capabilities to fulfill growing commercial drug product manufacturing demand, we are well positioned to support clients all the way to market. Our commercial site has been a center of excellence for over 22 years, with expertise in developing and commercializing over 25 products. Capabilities include:

  • Amorphous solid dispersion (ASD) capabilities via both spray drying and extrusion
  • Solvent and aqueous capabilities in fluid bed and coatings
  • Complex modified release dosages including coated pellets, tablets, and mini tablets for delayed release (DR), sustained release (SR), and custom release (CR)
  • Conventional immediate release (IR) tablets, capsules, mini-tablets, orally disintegrating tablets (ODT), and chewable oral solid products

We have made significant organic and inorganic investments over the past three years. With the recent acquisition of the Irvine site, BioDuro-Sundia fulfills a commitment made to its clients to support their development programs through registration and commercial drug product manufacturing. “In 2020, we significantly increased our discovery capacity along with drug substance capabilities through the acquisition of additional capacity for integrated discovery, drug substance, and drug product (~300,000 sq. ft.total).  This included staff with a strong track record of IND-enabling drug substance projects. We continue to invest in more scale and capacity to manufacture registration starting materials, intermediates, and drug substance services. We have 15,000L reactor capacity coming on line in 2023,” says Payne.

The company’s core expertise includes small and large molecule discovery and development and support for IND submissions. BioDuro-Sundia also has unique technology platforms, such as bioavailability enhancement for insoluble compounds, which can help improve certain drugs’ effectiveness. Our integrated services and solutions help biotech and pharma partners accelerate discovery and de-risk development to achieve higher-value outcomes. Our company pioneered contract services to address poor solubility and bioavailability issues using amorphous solid dispersion (ASD) technologies. Currently, our Solution Engine 2.0 allows screening ASD formulations with only 100 mg of API.

BioDuro-Sundia adheres to the highest standards of compliance and has a business operation code that prioritizes value. Its science-driven, customer-oriented culture allows the company to provide fast and flexible, tailored services that meet the unique needs of its customers and accelerate the development timeline. This culture is also people-focused, which enables the company to provide top-tier integrated services to its customers. “In 2023, we will have global operations across 7 cities with staff of over 3,000 employees across discovery, drug substance, and drug product. We offer clients turnkey solutions from formulation development through regulatory approval including commercial scale manufacturing under cGMP conditions with FDA inspected equipment,” said Kent Payne CEO, BioDuro-Sundia, “Today, we are poised to unlock next-level growth through expanded commercial manufacturing capabilities and integrated services.” David Preston, Chairman of the Board, BioDuro-Sundia stated, “Under Kent Payne’s leadership, we have generated record growth across all business units bringing on board new capacities at every facility, including discovery, development, and manufacturing.” The executive team, led by Payne, will continue to be co-located in the US and China, providing balance for the global contract research, development, and manufacturing organization (CRDMO).

“We acquired a 100,000 sq. ft. fully equipped and staffed commercial pharmaceutical manufacturing facility in Irvine, California on December 31, 2021. Through our team’s efforts, we seamlessly stood up all necessary licenses, processes, and procedures in order to begin commercial Rx manufacturing in less than three months on February 04, 2022. Under BioDuro-Sundia’s operation to date, the Irvine site has completed commercial manufacture of hundreds of batches across 5 FDA approved commercial products, which are now sold in pharmacies across the United States,” concludes Payne.


Kent Payne, CEO


“By facilitating successful outcomes with thousands of pharmaceutical companies, we have built a strong reputation for oral solid dosage (OSD) product development services from pre-formulation through clinical and commercial GMP manufacturing.”


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