Building Blocks of Global Success
CMC Biologics is the largest independent contract development and manufacturing organization dedicated to creating biologics.
The leading edge company produces API (active pharmaceutical ingredients) for the biotech and pharmaceutical industry, specializing in products that are based on genetic engineering of a cell to produce therapeutic proteins. The proteins that the team produces are developed into products for both clinical trial needs as well as for the commercial market.
The team provides a full spectrum of contract solutions from cell line development, cell banking and storage, process development, and analytical testing to both clinical and commercial manufacturing, quality services, quality control testing, and regulatory support. “We have a 15-year track record of technical success providing solutions to nearly 100 large, mid-size and small/virtual biopharmaceutical companies from five continents,” shares Stacie Byars, Director of Global Marketing. Currently, CMC Biologics is actively doing business throughout the U.S., Europe, Asia, South America and the Middle East.
In order to serve its global customers, CMC Biologics maintains facilities in Seattle, Berkeley, and Copenhagen. Each of the three locations allows the company’s customers to achieve their clinical and commercial manufacturing objectives for purity, potency, and accelerated timelines at multiple scales of capacity, while maintaining complete compliance with world regulatory agencies (FDA, EMA, ICH guidelines).
“We have manufacturing excellence in perfusion, mammalian, and microbial processes,” Ms. Byars adds.
With approximately 125 completed projects as of January 2015, CMC Biologics has developed and manufactured an extensive range of therapeutic proteins, including monoclonal antibodies, modified mAbs (FAbs, by-specific, nanobodies), coagulation factors, enzymes, hormones, cytokines, vaccines, fusion proteins, biosimilars, and more.
The ability to offer such a diverse array of products and services sets the company apart. “Our edge comes from our versatility,” Ms. Byars states. And, no matter what the specific project, the team always has leading experts on the job who are able to tackle the most difficult challenges. “Our competitive advantage lies within our ability to solve our customers’ most complex development and manufacturing projects.” This tech-savvy team is also able to use their knowledge to help push products through at a quicker rate. “Some of the technologies that we have mastered give us an edge to help customers meet supply faster than other CMOs,” explains Gustavo Mahler, PhD, Global Chief Operations Officer.
This superior technical ability combined with superior customer service creates a rare – and winning – combination. “We focus on two elements – technical expertise and our dedication to customer satisfaction,” Dr. Mahler reports. As a result, each customer can count on a complete, specially tailored solution. “We strive to go beyond our customers’ basic needs as they require, but we really excel by helping our customers to realize the true potential of their product(s). We help them with smart operational and development utilization of their investment.”
The company’s customer-centric approach means that the team is readily available and willing to help throughout the entire project cycle. “From proposal to product – we are intent in ensuring our customers have dedicated and technically sophisticated project management teams – access to top leadership for any project issue that the customer project team believes should be escalated,” Ms. Byars remarks.
CMC Biologics is enjoying strong growth, which has been driven by three different factors. The first factor is the acquisition of new – and larger – customers. “We have been able to access more customers in the market,” Mr. Mahler explains. “Also, we have been able to target some larger companies. At this point in time we are actually working with eight of the top 20 biotech and pharma companies in the world.” However, the team has not forgotten about the startups of the biopharmaceutical industry. “We also continue to provide solutions to small customers.”
Secondly, the company’s expansion is linked to the organic growth of customer products. “We are growing as our customers’ products are successfully moving through development phases,” Dr. Mahler explains. “The first type of service that we normally provide to customers is developing and manufacturing products for clinical use. After the clinical stage is successful, the product is approved and moves to the next stage of commercial production. There are very few CMO’s in the market that have the capability to provide commercial product to the biopharmaceutical industry. These are much bigger contracts over a much longer period of time.” While the initial R&D contracts are around $2 million to $5 million dollars, contracts for commercial products skyrocket to between $80 million and $300 million dollars and can last as long as seven years. “As our customers become commercial customers, we actually have larger contracts and those contracts accelerate the growth of our company.”
The third factor behind the company’s growth is geographic expansion. “We used to be very focused on U.S. and Europe only,” Dr. Mahler recalls. “A few years ago we started to target [other] markets. Japan is a main market that we are targeting, but we are also working in China, Australia, and South America. That has increased our geographical footprint and also our revenue, through these contracts in regions where we didn’t have coverage before.”
CMC Biologics is ramping up its production capabilities to keep up with increasing demand. The company just completed the expansion of its North American manufacturing facility in Seattle with the addition of a single-use Bioreactor 6Pack™ facility – tripling capacity at the site. “The Bioreactor 6Pack™ configuration consists of six 2000L production bioreactors and a 2000L seed train, allowing for flexible production with scales from 2000L to 12000L in a single production suite,” the company’s June 30th press release explains. “The bioreactors can be run in single unit operations or in groups, simultaneously, sequentially or in staggered fashion to achieve desired production needs.” Remarkably, the high-tech facility was constructed in just seven months in order to meet a major customer’s tight timeline.
The company’s Copenhagen facility is also set to undergo an expansion, adding approximately 12,000 liters of additional manufacturing capacity. Expected to be completed in 2016, this additional expansion in Copenhagen will create a Bioreactor 6Pack™ line that is identical to the new facility in Seattle, and provide customers with the ability to commercialize their products in both the U.S. and Europe.
In addition, the company’s Berkeley, California facility is enjoying a renewed focus. “We have recently brought our Bay area facility back online, enabling expanded operations in the bay area – a key region in the U.S. for early stage customers,” Dr. Mahler reports.
CMC Biologics’ successful growth makes the production of biologics look easy, but don’t be fooled – succeeding at the biopharmaceuticals game certainly has its challenges. For starters, the team has to deal with operational efficiencies. “We are continuously investing in the processes of systems to operate at a greater/more rapid pace,” Dr. Mahler points out. “We built a new team to manage this area of process operations; people resources (including consultants) and software implementation to automate the facility for planning and scheduling optimization.”
Recruiting talent is also an ongoing challenge. “This becomes increasingly more critical at top levels in the organization,” Dr. Mahler reports. “We are addressing this challenge through a more empowered middle-management; putting processes in place to enable optimal decision-making at middle levels; and adopting processes to decentralize the decision making process.”
Managing an influx of new personnel presents yet another challenge. “We have added nearly 100 new people in the last year; going from 200 to 300 employees in the U.S. The challenge is the ability to onboard this amount of people quickly and efficiently. We have met our operational goals through planned growth and created a structured approach to onboard and train on the personnel in the facility.”
The company’s ongoing growth is clear evidence that the team is overcoming these challenges. In fact, even more expansion is on the table. “We continue to expand our employee base and continue to grow based on customers’ demands [through] organic growth, but also through planned strategic acquisitions of additional facilities to serve our customers,” Dr. Mahler summarizes.
Already the largest company of its kind, CMC Biologics enjoys a position at the head of the pack – and is determined to build on its existing success.