Scottish specialty CMO thrives as 'one-stop-shop' becomes the trend: CMO Symbiosis Pharmaceutical Services, a small-scale, niche sterile manufacturer, finds market sweet spot in the development and manufacturing of biologics, highly potent APIs, and small molecules.
Symbiosis Pharmaceutical Services was established in 2011 in order to address specific gaps in the sterile drug product manufacturing marketplace. The Scotland facility was designed with biologic and small molecule sterile production capabilities in mind to support biotech and specialty pharmaceutical companies worldwide that require small-scale injectable products made to comply with regulatory standards.
"One of the key factors for most clients in deciding where to contract manufacture an injectable medicine relates to the regulatory framework," said MacKay. "From a regulatory perspective, there are a multitude of relatively minor regulatory differences between the prevailing guidelines of the European regulatory bodies like the MHRA and the FDA in the U.S.
"Given our focus at Symbiosis on sterile fill/finish and the GMP [good manufacturing practice] manufacture of small volume parenteral products for clinics, we have found those differences have had a very limited impact on our ability to provide for the requirements of our clients. In fact, we are seeing increasing harmonization across many of the pharmaceutical regulatory bodies worldwide. This is no surprise given their shared core objective of facilitating the safe development of new medicines and ensuring patient safety."
Although there is a steady demand for the company's sterile manufacturing expertise in Europe and the U.S., companies from across the globe have also approached Symbiosis--recognizing the company as a "go-to sterile manufacturing specialist."
"Europe and the U.S. continue to be our strongest markets, reflecting our strategic focus," said MacKay. "We have experienced significant growth in the U.S. in recent years and expect that to continue as demand from U.S.-based biotechnology firms looking for small-scale aseptic manufacturing capabilities to support clinical trials increases in line with their collective financial good health."
A Purpose-Built Facility
The Symbiosis sterile manufacturing facility in Scotland is 6,300 square feet with separate, dedicated areas for the receipt, quarantine, and storage of materials that the company receives.
"Our facility benefits from a modern purpose-built design and is deliberately positioned for small-scale, semi-automated aseptic GMP manufacture of sterile pharmaceuticals. It therefore reflects the latest technical and regulatory demands of our industry and therefore our clients," said MacKay.
The facility also contains:
* Two cleanroom suites
* A suite dedicated to the handling cytotoxic/highly-potent APIs
* Lyophilizers in each suite
* Vial washing and depyrogenation capability in-house
"In contrast to most CMOs, from the day we began operating we have offered short lead-time access to manufacturing slots and quick release of drug products to ensure tight timelines and expectations are successfully met. Naturally, this has been a real hit with our clients and has helped us to enjoy continued growth," said MacKay.
As a small-scale, niche sterile manufacturer, the company thrives on its flexibility--particularly to meet tight deadlines and customize its services to the specific need or requirement of a customer.
"Other larger CMOs offer relatively fixed offerings," MacKay explained. "At Symbiosis, we make sure we dedicate time to the front-end of each project to improve efficiencies throughout its duration and increase the chance of a successful outcome."
In addition, the company has come to utilize some of the latest technologies, such as single-use technologies, in their operations.
"Single-use technologies are the foundation of all that we do," said MacKay. "Their use has been part of our facility's design from the outset. They help us to achieve absolute compliance and simplify processes by eliminating cross-contamination of product contact surfaces."
In addition to attending industry conferences, which allows Symbiosis to meet new people and expand their client base, the company receives a number of service inquiries via their website.
"We respond to every client inquiry," said MacKay. "Whether it's a project that we can't handle due to capabilities or scale, we are happy to point people in the right direction. Assuming we are a good fit for the client project, we work in a collaborative manner with clients, under the strictest of confidence of course."
Prior to embarking on a program, Symbiosis representatives spend time asking questions from a technical, regulatory, project management, and service-level expectation perspective in order to have a complete understanding of a client's expectations.
"The probability of us achieving the client's expectations and ultimately delivering a successful project is increased significantly as a result of that," MacKay explained.
"Once we have a full understanding of the client need, we utilize the collective expertise we have at Symbiosis to not only provide a quote but also an overview of how we would deliver the project on the client's behalf in line with their expectations," he continued.
At the start of any project, the company works with customers to complete a full project appraisal.
"This gets to the heart of the client's own unique requirements and details key milestones and timings," said MacKay. "Many of our clients operate on strict timelines and so project scoping is essential to ensure on-time delivery of products for clinical trials. We also place great importance on reviewing project outcomes at the end of a project, continually learning, and improving our service delivery."
At the front-end, Symbiosis' lead time to access a manufacturing slot is routinely within a few weeks. After which point, they work to minimize the time from manufacture to batch release--targeting weeks as opposed to months so "the product can be subsequently used in clinical trials at the earliest opportunity."
Biologies, Highly Potent APIs, & Small Molecules
As a sterile drug product manufacturer, there is a significant demand for biologics, highly potent APIs, and small molecules from CMOs such as Symbiosis.
"Our decision to specialize in these areas was strategic from the inception of the company," MacKay explained. "The aseptic handling for manufacture of a range of sterile biologies is often very similar from a regulatory and operational perspective. Where these molecules really differ from each other is in the analytical methodologies that accompany each potential drug. Symbiosis has a breadth of analytical capabilities which it can direct at each project and each biologic molecule based on its inherent properties and unique analytical demands."
For small-molecule programs, specifically, "big pharma diligence," contracts, and longer timelines are often involved, said MacKay. The biopharmaceutical sector, in comparison, is fast-moving and time is a critical factor to demonstrate drug development milestone successes.
"There is a prevailing 'if you're going to fail, fail early' ethos in the industry as drug developers aim to bring novel therapeutics to market, often exploring unknown territories. The biopharmaceutical industry is also less bureaucratic, which makes fast decision-making possible," said MacKay.
Furthermore, market trends, such as the increased number of oncology products, has impacted Symbiosis' pipeline--validating the company's decision to have cytotoxic and highly potent drug-handling capabilities.
Trends in the Marketplace
"The industry is seeing lots of consolidation, with many mergers and acquisitions taking place to allow mid-sized CMOs to expand their service offerings and reach new geographies," said MacKay. "This is leading to a revival of the 'one-stop-shop' service provider model that big pharma used to retain in-house years ago and prior to the emergence of drug development outsourcing as we know it now.
"Despite this, we believe that there is still a need for specialist CMOs to deliver the agile and responsive service that is required in today's complex and fast-paced drug development landscape and Symbiosis positions itself deliberately to service that demand."
According to MacKay, this is particularly the case in the area of biologies--where complex and novel drugs require expertise as well as flexible and cost-effective development and manufacturing processes.
But what really makes Symbiosis stand out? Its employees, said MacKay.
"Our people set us apart--they make things happen and this fosters a positive and rewarding working environment and a collective culture focused on delivering for our clients.
"Knowing that we make a contribution to help bring new treatments to market for the benefit of real patients motivates us, as does contributing to the increased health of a growing and aging global population."
By Meg LaTorre-Snyder, Editor
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|Article Type:||Cover story|
|Date:||Apr 1, 2017|
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