The company has a strong and history of small molecule API manufacturing and a global network of development and manufacturing plants. In the past year, Cambrex acquired both Halo Pharma and Avista Pharma Services, diversifying the company’s offering to include formulation development and finished dose clinical and commercial manufacturing, as well as analytical development services.
Its team of experts offers an end-to-end partnership for the research, development and manufacture of small molecule at every stage of the lifecycle. From IND enabling through to generic Cambrex offers classic chemistry, formulation and testing in addition to specialized technologies including: enzymatic biotransformations, high potency APIs, continuous processing, pediatric, bi-layer and fixed dose combination formulations and has experts dedicated to solid state science and material characterization.
Contract Pharma had the chance to sit down with Cambrex’s executive vice president and chief operating officer, Shawn P. Cavanagh, to talk about how the company has integrated the new services and businesses into its existing operational structure, and the current nature of the small molecule market.
Contract Pharma (CP): What was the strategy behind the acquisitions of Halo and Avista?
Shawn Cavanagh (SC): The two companies offered the opportunity for Cambrex to broaden and diversify our service offering in what is our continued mission to become the leading small molecule company. The acquisitions significantly increased the customer base and funnel of projects, and we now look to partner with customers for projects across the whole lifecycle of small molecule drugs, from pre-clinical development through to commercial launch.
CP: How have these new services been integrated into Cambrex?
SC: The integration of Halo and Avista into Cambrex has allowed us to structure the business into three key offerings for innovator customers:
The drug substance offering incorporates the majority of the legacy Cambrex API business which includes the development and manufacturing of innovator APIs; the scale-up and technical transfer of projects and analytical development; and also includes specialist capabilities such as handling of controlled and highly potent substances, continuous flow chemistry, biocatalysis and solid state science.
The drug product offering has expertise in formulation and development of conventional dosage forms including oral solids, liquids, creams, sterile and non-sterile ointments; as well as specialist drug product capabilities including developing and manufacturing highly complex and difficult to produce formulations, products for pediatric indications, and controlled substances.
Finally, our extensive analytical capabilities support our drug substance and drug product projects but are also provided as stand-alone services. Analytical services include capabilities such as microbiology testing, cleanroom services, material characterization, method development and validation, compendial and release testing, as well as stability storage and testing.
Both of the new capabilities in drug product and analytical services complement our existing capabilities and expertise in contract manufacturing of APIs. The businesses were a natural fit, and have increased the opportunities for us to offer a wide range of services to new and existing customers.
CP: What demand are you seeing for the outsourcing of small molecules? Why strengthen in this space?
SC: As a company, Cambrex’s history and expertise is very much in small molecules and as I mentioned, our long-term strategy is to be the leading small molecule CDMO partner with the ability to serve customers across the pharmaceutical industry, from small and virtual biotech to large pharma.
What we have seen from the market data available is that the small molecule pharmaceutical market continues to grow at the fastest rate seen in more than a decade, and there is a healthy clinical pipeline as well as high numbers of FDA approvals for small molecules. Additionally, there is a robust funding environment for early-stage clinical programs available, as well as an increasing trend for pharmaceutical customers to outsource more of their small molecule requirements.
These factors were the basis to make the acquisitions and expand Cambrex into new markets, while maintaining our focus on our expertise of small molecule therapeutics. Customers will now have the choice of selecting the appropriate service or services to fit their needs. For some customers, this may be for just one aspect, but for those companies who may not have the time or resource to manage multiple service providers, they also have the option of partnering with Cambrex as its sole CDMO supplier for both drug substance and drug product. The services we now offer mean that we can work with a drug throughout its entire lifecycle, from early pre-clinical development to late clinical phase and commercial launch.
CP: What challenges does the industry face, and how is Cambrex looking to address these?
SC: As is always the case, the pharmaceutical industry continues to evolve, and although we see a healthy clinical pipeline and a high number of FDA approvals for small molecules, the nature of these molecules has changed. Commercial products are not just the blockbusters that require large volume assets producing hundreds of metric tons of API annually. Today’s drug substance requirements for a drug may be no larger than a metric ton in order to facilitate an orphan drug launch, or require contained manufacturing due to their high potency. As a CDMO, we must recognize these changing needs and adapt accordingly to be able to offer the most suitable solutions in terms of capacity, expertise and technologies to customers. This has been the principle behind our investment strategy over the last 5 years, ensuring that as a company we have not only have the capacity available for new projects, but the right capacity to ensure that projects can be carried out efficiently and economically throughout their development and lifecycle.
As well as the projects, customers change too. Alongside the multinational pharmaceutical companies are the small and virtual companies that are investing greater resources and progressing products further down the clinical pipeline. The needs of each customer are different, but some common themes exist in that they are looking to reduce the burden of managing complex supply chains and work with a smaller number of strategic outsourcing partners and suppliers. This has led to consolidation in the service sector, and again, has been pivotal in the strategic decisions Cambrex has taken with our investment in technologies, manufacturing capabilities and our recent acquisitions to broaden our service offering.
CP: What is next for Cambrex?
SC: The two acquisitions added over 800 employees and 6 new facilities to the company, so short-term, we are focused on ensuring the values of the companies and the expertise we have across the businesses are aligned so that we can continue to deliver on the promise we have to our customers.
Aside to the acquisitions, we see no let-up in the momentum of our existing drug substance business. At our Charles City, Iowa site, we have recently opened a new $24 million, 4,500-square foot facility for the manufacture of highly potent APIs, with an occupational exposure limit (OEL) down to 0.1µg/m3. We began this project in 2017 to accommodate the needs of the growing pipeline of drugs which require specialist manufacturing capabilities. The new facility in Charles City, Iowa has the flexibility to support all phases of development as well as all scales of drug substance manufacture across the full OEL high potency continuum.
Additionally, we have purchased a new 45,000-square foot building in High Point, North Carolina, giving the site the flexibility to expand its clinical supply and process development capabilities. We are in the process of looking at the options and assessing the market demand so that we can continue with our strategy of providing best-in-class services to meet the needs of our global pharmaceutical, biotech and generic customers.