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Scottish CMO sets up shop in U.S.: symbiosis' business development director Joanne Anderson weighs in on biologies fill/finish trends.

Sterile manufacturing specialist Symbiosis Pharmaceutical Services is a contract manufacturing organization (CMO) that specializes in the cGMP manufacture and sterile fill/finish of vials for clinical trials and commercial supply. Back in 2015, the UK-based company made the decision to strategically focus on the North American market after identifying a surge in funding for early stage biotechs. Earlier this year, Symbiosis opened a new commercial site in Cambridge, MA, to support its East and West Coast clients with its vial-filling services including liquid and lyophilized formulations in injectable dosage forms. Joanne Anderson, business development director at Symbiosis, talked with Contract Pharma about the company's recent expansion as well as biologies fill/finish trends in today's market.--TW

Contract Pharma: How would you describe the current biologies fill/finish market?

Joanne Anderson: The market will always be subject to change, but we believe there is significant market demand for aseptic manufacturing capabilities for biologics. This has been boosted by a positive investment climate in the biotech space, particularly in the U.S., which in turn is facilitating the development of new biological drugs, increasing the depth of an industry-wide drug pipeline and fueling demand for outsourced manufacturing services to bring products to the clinical trial stage.

Within the fill/finish market customers need to choose whether to work with a big one-stop-shop service provider or smaller, more specialist and flexible partners. Specifically, it comes down to what will get the client to clinical trials in the safest and quickest route they possibly can.

CP: What are the main trends in the biologies fill/finish market today?

JA: Fill/finish is historically one of the most outsourced activities due to the high cost of equipment, quality infrastructure and facility requirements. Many contract manufacturing organizations (CMOs) have experienced a surge in the market due to several factors, including the decrease in the amount of high-quality CMO capacity available for aseptic fill/finish.

There are specialist CMOs such as Symbiosis whose focus is on fill finish and we have built an operational flexibility to move our clients through the clinical development stages quicker than our larger, less nimble competitors. In contrast, several of the larger CMOs are looking to extend their service offering to align with the one-stop-shop service provider model.

The industry is also seeing lots of consolidation, with many mergers and acquisitions taking place to allow CMOs to expand their service offerings and reach new geographies. This is leading to a revival of the 'one-stop-shop' model that big pharma was made up of years ago.

We believe that there is 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.

There is a positive investor climate in the market, which means that drug developers are under increasing pressure to demonstrate the success of their promising molecules at an early stage. Experience has taught us that there is a real market demand for rapid access to manufacturing slots. This can help to make up for lost time in the earlier project stages.

This is particularly true in the area of biologies where complex and novel drugs require specialist expertise and a flexible and cost effective process. Therefore, opportunities to speed up time to clinical trials and minimize losses during drug product manufacture are demanded, and our ability to meet these needs is a major contributing factor to our growth and success.

We also find that small and mid-sized drug developers value cultural fit and true partnerships when selecting a CMO for their projects. Often this requires a smaller, nimble CMO that can deliver a personalized service.

CP: What do you believe are the key factors to success in the biologies fill/finish market?

JA: Success in fill/finish outsourcing is underpinned by technical capabilities and effective communication on both sides of the supply contract. The relationship between the client and service provider is fundamental.

As a result, we are seeing more and more clients moving away from tactical outsourcing initiatives in favor of a relationship-oriented strategic partnership with CMO partners across a collaborative supply chain.

Due to the nature and complexity of sterile fill/finish, most drug developers need a long-term vendor that will invest time, energy and resource into achieving a productive outcome.

The long-term benefit for a CMO like Symbiosis is we grow and scale-up as clients' products move through phases. It also gives us a strong understanding of each client's product and process, which we may have developed, adding huge value when it comes to increased batch outputs and meeting clinical deadlines.

We also increasingly see that new drugs are being developed for very specialized disease states and unmet needs. This results in much smaller patient populations and hence smaller batch sizes, which has a significant impact on operations and the technologies that are the best fit for the application.

We have focused on flexible equipment and single-use disposable technologies at Symbiosis to enable fast product release, the flexibility to produce small sterile batches for trials and eliminate potential for cross-contamination.

Having specific experience in handling biologic drug substances is a significant advantage for a specialist CMO like us as it reduces the potential for process loss and risks when handling some very high value materials.

CP: And what are the main barriers/issues in the market?

JA: Fill/finish is often characterized as the most critical step in drug manufacturing due to its highly specialized nature, which makes it difficult to get products to market or clinical trials. In addition to being extremely costly, fill/finish operations are quite rightly subject to extreme scrutiny by regulatory agencies.

We have recently seen more stringent requirements from the regulatory bodies, with aseptic fill/finish one of the main areas of focus and quality standards remaining a major challenge for some CMOs.

Clients are rightly vigilant when placing their projects with sterile CMOs. By demonstrating robust and continuously improving quality systems and a strong regulatory track record with the MHRA, who are regarded globally as a gold standard, clients are reassured when dealing with our team, knowing our operations absolutely comply with prevailing regulations.

Domestic market preference to have manufacturing located near to the demand could increase the presence of facilities in developing regions, but it will take time to build experience and confidence there. Aseptic fill finish is the highest risk mode of drug product manufacture, hence confidence in the facility is key.

We expect to continue to experience growing demand from U.S. biotechs that are undertaking clinical trials in Europe. By choosing a GMP manufacturer based in Europe, drug developers can ensure compliance with the QP standards required to release a drug product for a European based clinical trial.

In reality, the industry and our sector is truly global. Within drug development, clinical trials are now conducted all over the world. Most clients are concerned with many other factors beyond locality.

CP: What do you think the future holds for the biologies fill/finish market?

JA: The outsourcing sector will no doubt continue to grow over the next five years, with particular growth in the parenteral manufacturing space coming from biopharma companies as they begin to progress new drug products thanks to an increase in funding.

Despite the demand for services, due to the substantial barriers to entry and increasing quality demands, we don't expect to see many new players entering the market. While many CMOs continue to expand their offerings, there will continue to be demand for niche manufacturing services from specialist providers that can offer the flexibility needed to meet increasingly tight timescales in the drug development pipeline.

Time and flexibility often have a very high influence on the selection of a fill/ finish CMO partner, and clients can sometimes underestimate the complexity of setting up fill/finish operations that are suitable and scalable.

As a result of this we are also seeing more experienced innovators engaging external support earlier in development, and some are seeking more strategic relationships that begin at an early stage of development but consider the needs of later stage supply.

CP: How will Symbiosis capitalize on this? What does the future hold for the company?

JA: As a result of increased global demand, Symbiosis has grown by around 40% over the last year and has also continued to recruit steadily, increasing staff by 30% to meet demand for its specialist aseptic fill/finish service.

Europe and the U.S. continue to be our strongest markets. We have experienced significant growth in the U.S. in recent years and expect this to continue as demand for our expertise in filling biologic and small molecule products, combined with our ability to offer rapid access to sterile manufacturing slots, has been very well received by preclinical and Phase I-III biotech and pharma companies.

Since strengthening our U.S.-focused personnel and developing our relationships with networks like MassBio and ISPE, we have significantly grown our U.S. client base, which is projected to account for around half of our revenues in 2017.

In January, we opened a commercial site in Cambridge, Boston, MA, to support our clients on both the East and West Coast U.S., and provide a base for reaching new customers in this territory.

Regulatory compliance, technical capability and operational flexibility are still core to Symbiosis' offerings. Ifs about the level of service you can deliver to your customers, how quickly you can offer them access to your services, along with an absolute ability to consistently demonstrate regulatory compliance of the highest standards.
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Title Annotation:NEWSMAKERS
Author:Anderson, Joanne
Publication:Contract Pharma
Date:Jun 1, 2017
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