Prime Synthesis

Throughout its 20 plus-year history, Prime Synthesis had achieved success through a focus on its core product, Controlled Porosity Glass (CPG) for the DNA synthesis market. Continued research and development of CPG recently led to a new product which the company believed had potential for purification-related biochemical applications – a new market for Prime Synthesis. The new CPG product had the capability for higher loading – an advantage in the new target market space. According to Prime Synthesis President Marc Rothstein, “We felt that this characteristic would be an important benefit to drug makers, but we needed to verify that. Also, if our assumptions were correct, we knew we’d need a big investor to partner with us in bringing the technology to market.”

Rothstein came to DVIRC for support in exploring the market potential for this new product and developing a strategy for moving forward. “We wanted to better understand the market opportunities and possible barriers for our new technology,” said Rothstein. “I was familiar with DVIRC and thought it would be helpful to take advantage of the resources, support and guidance they could offer.”

RTI Innovation Advisors are uniquely qualified to assist technology-based companies. Each has a combination of expertise in a specific technology field as well as in business. RTI selected an RTI Innovation Analyst with expertise as an analytical chemist to lead the TDMI effort for Prime Synthesis.

According to an RTI Innovation Advisor Tom Culver, “The challenge was to develop an understanding of the target market in terms of market demand, constraints, size, what is needed to compete in this area and how Prime Synthesis would be positioned in the value chain. We wanted to clearly understand what this world looks like – and define the opportunities and barriers for commercialization of Prime Synthesis’ specific technology.”

RTI gathered existing market data and reviewed published academic and scientific literature related to the Prime Synthesis technology and potential applications. They identified key players in the market and arranged interviews with them. “RTI has a world-wide reputation for facilitating the introduction of new technologies,” notes Culver. “This opens doors to key players in specific industries. They know that by helping us understand their applications and processes, we can play a role in bringing beneficial technologies to the market. As a third-party player, we can have discussions that would not be possible for manufacturers and developers like Prime Synthesis.”

Findings

The RTI research revealed that the potential for the Prime Synthesis technology was even greater than anticipated, especially in the production of billion-dollar, blockbuster drugs. “We looked at the market and were surprised at the size and fast growth potential for Prime Synthesis’ new product,” noted the Culver.

RTI research revealed:

• To increase the market for highly expensive drugs, manufacturers needed to reduce the cost of the drugs. Enhancing manufacturing efficiency and productivity was the strategy for doing so. More importantly, RTI discovered that Prime Synthesis’ technology addressed the rate-limiting step in the production process. “RTI confirmed that this production step is slow and expensive,” noted Marc Rothstein. “It’s the bottleneck that limits how quickly a drug is produced. If you can create a better mousetrap for processing, you have a key driver. And, that’s exactly what Prime Synthesis has developed.”
• FDA regulatory issues would need to be addressed in order for a drug manufacturer to change the raw materials used in the purification process. This highlighted the need for Prime Synthesis to partner with a company with the ability to navigate the requirements for FDA compliance.
• The target market offers Prime Synthesis the potential for $100 million in annual sales.

Credibility
With the guidance of DVIRC and the research provided by RTI, Prime Synthesis is ready to begin searching for potential business partners and developing a strategy for entering the new biochemical processing market. “RTI gave us a well-documented, concise, highly credible report – a tool we can use to go shopping for partners,” noted Rothstein. “We now have the ammunition to go to major players and show that we have the answer to their production efficiency issues.”

Cost Avoidance
The findings of the RTI research helped Prime Synthesis realize that a proposed partnership with a Korean company was a strategy with limited potential. Prime Synthesis made the decision to dissolve the partnership and focus its resources on targets indentified in the RTI report.

Investment
DVIRC directed Prime Synthesis to the MATAAC funding resources. With DVIRC’s assistance, Prime Synthesis qualified for up to $150,000 in cost share funding, and used the money to pay for work related to their new technology, including patent protection, the RTI research, and the development of a website.

Prime Synthesis was established in the late 1980s in response to the explosive growth of the then-emerging science of molecular biology and genomics. For the past two decades, the company has focused on the development and production of DNA synthesis materials for the biomedical research field. Located in Aston, Pa., Prime Synthesis has a staff of 14 and operates out of a 20,000 square-foot facility housing research laboratories, production areas and administrative offices. The company recently completed construction of an additional 10,000 square-foot, Good Manufacturing Practice (GMP)-compliant production area with a suite of organic synthesis work areas, controlled porosity glass processing areas and a state-of-the-art quality control laboratory.