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March 6, 2018 Manufacturing Insights

PCI Synthesis celebrates 20th year with new achievements

Courtesy | PCI Synthesis PCI Synthesis President Ed Price

Newburyport pharmaceutical manufacturer PCI Synthesis, which operates a manufacturing facility in Devens, announced last wee it has achieved double-digit growth for the fourth consecutive year. That growth includes hitting new milestones and entering into new markets in the start of 2018, which marks the company's 20th anniversary. Ed Price, president of PCI Synthesis, took part in a Q&A session with the Worcester Business Journal to talk about the company's recent success. 

Congratulations on the company’s 20th anniversary and recent success. What has led to that growth?

Over the last few years, we’ve received a number of commercial approvals, which has increased the number of chemical products we can sell directly. Additionally, our manufacturing and development services have become an ever increasing demand in the local biotech community. The industry has recognized the quality of our work; we’ve won 24 CMO (Contract Manufacturing Organizations) Leadership Awards from Life Science Leader magazine. In fact, last year, we won the “Top Performer” designation in all 14 categories last year – the only CMO to do so last year. Last year we closed our fourth consecutive year of double-digit growth.

What new products are driving that growth?

Increased demand for pharmaceutical development outsourcing services. We’ve added 40 new customers and expanded into new offerings such as manufacturing for nutraceuticals and pharma foods, large-scale cryogenic manufacturing, large-scale chromatography, controlled substance development, and medical-grade polymers.

The company has a facility in Devens, but is based in Newburyport, so we’re not too familiar with PCI Synthesis. What does the company produce?

PCI Synthesis operates in two main verticals: We are an outsourcing partner for biotech and biopharmaceutical companies and we are also a commercial manufacturer with active pharmaceutical ingredients. Over the last few years, we received a number of commercial approvals and our manufacturing and development services have become an ever increasing demand in the local biotech community.

What is the company’s main product?

PCI Synthesis has a portfolio of eight commercial active pharmaceutical ingredients we manufacture for U.S. generic pharmaceutical companies. PCI Synthesis is the largest small molecule drug substance manufacturer in New England. We provide emerging and midsized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules. Companies come to us for help from initial process research to commercial manufacturing. We have 20 years of experience in chemical manufacturing, which has enabled us to develop deep expertise. Clients choose us not only for our science expertise but also for our project management expertise; we strive to keep our clients constantly informed about the progress of their projects, and provide them with regular weekly updates on every aspect of the work we are doing. That’s important – because of the science we’re doing on their behalf is cutting-edge, we also make sure that any issues are brought up immediately so that we can collaborate with our clients solve the small problems before they grow into big ones.

The company recently received federal clearance to develop controlled substances. What controlled substances has the company produced so far?

We work on a variety of compounds considered controlled substances. We invested in new equipment, additional infrastructure and training to comply with state and federal regulations in order to receive U.S. Food & Drug Administration approval. Since last year, we’re able to meet the growing demand for new molecules that make use of the medical value of controlled substances. We now have three suites to handle controlled substances but the projects we work on are all confidential. These controlled substances are not necessarily all for pain but for a variety of different indications.

Is there some heightened sense of responsibility in doing so, given the opioid epidemic?

The goal is to develop new molecules that make use of the medical value of controlled substances without the addictive qualities. Not all the controlled substances we work on are necessarily for pain, some are for a variety of different indications – but the goal is to develop more effective medicines without the downsides that led to the epidemic. Keep in mind, too, that before receiving FDA approval, we needed to put in place new procedures for a new level of quality control, and vast employee training in how to handle different materials and comply with state and federal regulations. Security is one of the most critical areas for manufacturing controlled substances, and we revamped our entire processes and physical features to ensure specific security requirements are met. For example, employees working in any function must have thorough background checks, as well as secure restricted access permission for entry into facilities, and cameras in all entry ways. We added this capability to work with our clients who are working in this area.

The company opened a San Diego facility in 2017. What is the talent pipeline out there compared to Massachusetts?

The San Diego office is a sales office, not a facility, to help extend our reach to better serve West Coast clients. Boston has the largest biotech hub in the country, but we also wanted to expand to the West Coast to tap into biotechs located there. We have found the talent in San Diego to be comparable to what we have in the Boston area.

This interview was edited for length and clarify by WBJ Staff Writer Zachary Comeau.

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