BioSymphony Platform

//BioSymphony Platform
BioSymphony Platform 2018-11-08T20:40:38+00:00

Rapid Development of Technically
Challenging mAb Therapeutics

Our BioSymphony Platform is designed to address the technical challenges and regulatory dynamics of the complex biologics industry by developing high quality mAb therapeutics on an accelerated timeline and in an efficient and cost-effective manner.

BioSymphony Platform
  • Driven by our entrepreneurial culture, the BioSymphony Platform leverages our fully integrated in-house 66,000 square foot development and manufacturing facility and our team’s clinical and regulatory expertise.

  • For our biosimilars portfolio, we believe this model enables significant pricing flexibility, providing us with competitive advantages, and positions us to be a leading biosimilar company.

Oncobiologics Development Capabilities

In-House Development Capabilities

We have established a research and development laboratory, which we believe enables the rapid development of high-quality mAb therapeutics. By establishing this infrastructure in-house, we have shortened the typical time required to perform the mandatory interdisciplinary iterative steps to develop mAb products, which we believe reduces the cost of development.

GMP Manufacturing

In-House Manufacturing Capabilities

Our state-of-the-art manufacturing facility is capable of simultaneously producing multiple biosimilar candidates. Our manufacturing platform utilizes single-use technology, including the the largest single-use bioreactor available, which eliminates the need for rigorous cleaning and sterilization procedures, and related operational requirements necessary for manufacture in traditional stainless-steel based facilities.

Development-Manufacturing Integration

We believe we have successfully and seamlessly unified our development capabilities and manufacturing processes to minimize time lapses and risks that are frequently encountered in drug development.

Our internal processes eliminate the need to transfer technology and processes to third-party manufacturers. Technology transfers are commonly performed through formal procedures consisting of the transfer of know-how, followed by manufacturing process gap assessments, and then finally replication and scale-up of the development process at manufacturing scale. These technology transfer proceedings can take upwards of six months or longer, and could have an adverse effect on product quality. Our platform gives us the ability to initiate manufacturing within approximately six weeks of process development completion.

Regulatory and Clinical Approach

The regulatory requirements for the development of complex biosimilars are significantly different from those for novel biologic therapeutics.

These biosimilar regulatory expectations are still evolving with new drafts and final guidance being made public by regulatory authorities worldwide. Due to the limited number of biosimilar regulatory approvals and developing guidance, prior regulatory feedback may not reflect the current expectations of the applicable regulatory authorities. We have developed a global regulatory risk mitigation strategy that we believe allows us to ask the right questions at the right time, enables us to ask probing questions to explore regulatory boundaries, provides the potential to set precedence and assures alignment with regulatory authorities. 

Our People and Culture

MAb development presents high technical hurdles, and the success of our development efforts is dependent on an experienced and knowledgeable work-force.

We were founded by a team of industry veterans, with decades of cumulative experience in biologics development and commercialization at some of the leading biopharmaceutical companies including Eli Lilly, Bristol-Myers Squibb, Pfizer, and Genentech. Our leadership team has built a platform with the goal of expeditiously identifying, developing, manufacturing and commercializing mAb biosimilars in an efficient and cost-effective manner. We have fostered a culture of agility, collaboration and efficient decision-making with a focus on scientific rigor, which we believe forms the core of our BioSymphony Platform.