BioDuro-Sundia
Trusted Partner For Drug Discovery And Development To Commercialization

The transition from blockbuster to precision drugs has ushered in a new era for medical science, allowing physicians to more efficiently treat patients. To make this transformation effective and help patients get precision medicines on time, biotech and pharmaceutical firms must accelerate their drug discovery, development, and commercialization processes.

The endeavor of faster drug development, however, is often hindered by small molecule solubility and permeability issues. This necessitates biotech and pharmaceutical companies to seek solutions that can improve molecular solubility and bioavailability while streamlining the target discovery to commercial product manufacturing processes.

BioDuro-Sundia, a leading Advent International portfolio company and a contract research, development, and manufacturing organization (CRDMO), is tackling head-on the issue of low solubility of active pharmaceutical ingredients (API). Deploying spray drying technology and proven formulation development knowledge, it improves the bioavailability of insoluble substances and provides feasibility studies and clinical trial material manufacturing in amounts ranging from milligrams to kilograms.

Core offerings include small and large molecule discovery, development and scale-up, support for IND submission, and technology platforms like bioavailability enhancement of insoluble compounds. It is a onestop shop with fully integrated services from target identification to commercial drug product manufacturing. This helps clients develop medications quicker than conventional market standards.

"We are the largest privately held drug discovery platform. Our global presence gives us the scale to work with emerging biopharmaceutical companies as well as large pharma clients,” says Kent Payne, CEO, BioDuro-Sundia. “Our ability to be nimble, fast, and flexible is crucial to deliver the projects efficiently within a stipulated timeframe.”

A Long-Standing Legacy and Drive toward Technological Excellence

BioDuro-Sundia has been a trusted CRDMO for nearly three decades. The credit goes to its team of industry leaders and midtier managers, who have worked globally and adhere to the highest standards of compliance and business operation codes during drug discovery and development.They are also instrumental in creating a legacy of innovation, diversification, and high-quality science productivity and compliance.

This was illustrated in early 2022 when Team BioDuro-Sundia rapidly stood up a recently acquired commercial GMP oral solids plant in Irvine, CA with fully-fledged processes and procedures within 35 days of acquisition.

In 2022, BioDuro-Sundia manufactured over 300 commercial batches across 5 Rx products that have been put on shelves of pharmacies across US for patient use.

Since its inception, its founders were interested in exploring new medical solutions in critical areas like oncology and metabolic diseases.However, advancing these studies requires a large pool of researchers, which was difficult to assemble at the time at scale. To address this gap, BioDuro-Sundia expanded to China and eventually grew to serve multiple global clients, leveraging best-in-class drug discovery and development services and a sheer focus on protecting their IP.

Along with infrastructure growth, BioDuro-Sundia has incorporated the latest technological advancements into its service roster. It acquired a drug discovery platform in 2013, which enhances solubility and bioavailability to help clients find and refine targets. The technology uses spray drying or extrusion technologies, offering a stable, amorphous, solid dispersion, and providing the drug’s most soluble form in an oral tablet or capsule for easy delivery.

In 2015, BioDuro-Sundia started proteolysis-targeting chimeras (PROTAC) research. It has established a library of linkers available in-house, along with the knowledge and expertise on linker design and synthesis. Meanwhile it built a one-stop platform for in-vitro evaluation that can ubiquitinate the target proteins through the ubiquitin-proteasome system (UPS). Seeing its progress, a leading pharmaceutical company approached it to advance their PROTAC research. BioDuro-Sundia’s experiments and recommendations streamlined the research process that was really differentiated.

Another key offering is Solution Engine 2.0, a platform that combines computer modelling of miscibility, in-vitro screening, and in-vivo PK to deliver the highest quality amorphous solid dispersion prototypes with only 100 to 200 mg of API. It screens and identifies optimal physicochemical, formulation, and ADME properties, and cost-efficiently accelerates drug discovery and development.

A Constant Focus on the Intricate Needs of Customers

BioDuro-Sundia undertakes a flexible approach while engaging with clients. This is crucial to deliver high-level scientific competence and meet global standards. Its strategic commitment to faster drug development and flexibility attracts new prospects and assures customers return.

For instance, a firm (with a history of collaboration with BioDuro-Sundia) was struggling with multiple failed attempts at other providers to improve a molecule’s solubility. Once the client shared their needs, BioDuro-Sundia deployed Solution Engine 2.0. to address the problem. Beginning with in-silico, assessments followed by in-vitro and in-vivo screening of the API requiring about a hundred milligrams of API. The ability to screen small quantities, BioDuro-Sundia is able to get the drug development process started early and save clients significant time and money. The screening study including two rounds of rodent PK studies in executed within only 8 to 10 weeks. BioDuro-Sundia’s in-house drug metabolism and pharmacokinetics (DMPK) tools allowed it to conduct in-vivo studies quickly and offer the customer a rank order of bioavailability among different polymers to pick the one most likely to deliver a favorable solution. Consequently, the client raised substantial money based on the Solution Engine 2.0 data. Last year, the client also went through an IPO, creating over a billion dollars in market capitalization. BioDuro-Sundia currently helps this client advance in clinical trials.

“We offer multiple enabling technologies and combine significant internal compliance and governance at every stage of drug development. This helps us be the repeated choice for our existing customers and attracts new prospects in the drug development sector,” adds Payne.

Developing New Capabilities to Meet Market Needs

BioDuro-Sundia is rapidly expanding. It is bringing a new capacity in drug discovery online and is building a plant with significant scale and large reactors. The firm also acquired a commercial facility in 2022, where it is installing a large GEA NIRO® PSD-4 spray dryer (max. drying air rate: 1,250 kg/h) and related commercial equipment train.

BioDuro-Sundia has capacities to support clients’ projects on stabilized amorphous solid dispersion technologies as well as modified release (fluid-bed and pan coating) from pre-formulation development through Phase III and commercial manufacturing.

“We have evolved with the market and technological advancements and will continue to do so to meet our clients’ growing expectations,” states Payne.

BioDuro-Sundia’s extensive experience, topnotch technologies, infrastructural capabilities, and ability to work its way through to resolve complex client challenges and deliver quicker drug development needs makes it a CRDMO company biotech and pharmaceutical companies need today and in the future.