How Recipharm AB, with locations across Europe, has broadened its pharmaceutical development capabilities and presence as a CDMO.
Offering manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material, and pharmaceutical product development, Recipharm AB has emerged in recent years as a leading contract development and manufacturing organization (CDMO) based in Sweden. Consisting of 2,200 employees, the company currently manufactures more than 200 different products for both Big Pharma and smaller R&D companies.
Recipharm was established in 1995, but did not have a presence in the contract manufacturing business until a number of years later. In 2001, the company established the brand name Recipharm, and between 2001 and 2007, six facilities were acquired, which impacted both their capacity and their business. It wasn’t until 2007 that Recipharm decided to dedicate its resources fully to its CDMO business.
“We started as an MBO of a Pharmacia solid dose facility in Stockholm which was too close as part of their network rationalization,” said Mark Quick, Executive Vice President, Corporate Development, Recipharm AB. “Our founding managers agreed to buy the facility from them and one of the initiatives to increase volumes was to create a CDMO. This proved to be a very successful strategy and was the start of our journey.
“The next step came in 2006 when the company divested the majority of its own products to Meda AB in order to focus even more on the CDMO business. In April 2014, the company got listed on the Stockholm Stock Exchange.”
Currently, Recipharm has facilities in the following locations:
- Jordbro (HQ)
Recipharm supports pharmaceutical companies in taking their products from early development to commercial manufacturing and throughout the product lifecycle.
“We focus our efforts on different dosage form and manufacturing a high-quality product,” said Quick. “We do have some special technologies and we are, for example, one of the largest players in lyophilization which has applications in biological products.”
The company has been involved in lyophilization since 2008 when they acquired a small facility in Switzerland (which is no longer operating). Since that time, they acquired two additional facilities—one in Germany and another in Italy—that provided them with additional capacity and capabilities in their manufacturing process.
When it comes to Recipharm’s general process of filling and lyophilizing vials in varying batch sizes, the most important issue—according to Quick—is that each step of the production process takes place under the required and appropriate cleanroom conditions.
Recipharm’s process for filling and lyophilizing vials in varying batch sizes are as follows:
- The active ingredient has to be dissolved in dedicated vessels.
- Bulk solution is filled into vials and covered with a specific designed stopper, which has an opening. This is important for the following process of sublimation during the freeze drying.
- After the filling, lyphilization (the most difficult step in the process) takes place in the freeze dryers.
- Finally, the last steps are the closing and capping of the vials.
“Biological products tend to be less stable in liquid form,” said Quick. “Therefore lyophilization provides a means to increase the shelf life. However, not only do biological substances tend to be more unstable in a liquid form, but many chemical substances are also significantly unstable in a liquid form (as compared to a solid form). A molecule which might be stable as a solution for weeks only can be stable as a solid dosage form for months or years. In addition, freeze drying is a very gentle process to make sensitive biological substances stable for longer.”
On a whole, Recipharm works with a high degree of flexibility in order to meet their customers’ varied needs.
“On several sites we are able to manage both customer managed inventory (CMI) and vendor managed inventory (VMI) supply models—depending on what the customer wants to have,” said Quick. “We are also able to manage processes beyond the pure contract manufacturing business, i.e. supply chain management and quality processes.
“One of our key strengths is the ability to bridge our development and manufacturing services by providing the possibility for customers to bring their product all the way through development into commercial supply with Recipharm as one partner.”
Depending on the complexity of a given program, the company typically works with a lead-time of approximately three months for regular production. They can, however, work faster on different products, but this would depend on the nature of the individual program.
“We have the ability to run small-scale CT batches in our development facilities,” Quick explained, “but we can also use our commercial manufacturing plants to run larger batches, i.e. for Phase III trials.”
Although the company’s headquarters are in Jordbro, they remain abreast of other pharmaceutical climates and new compliance concerns.
“Development of new regulations and legislation always bring a bit of challenge when you are working in an international environment,” said Quick. “But Recipharm has a good history of adopting to new requirements and we have good processes to develop our ways of working—both generally and in specific areas like GMP.”
The company is also addressing the new DSCSA (Drug Supply Chain Security Act) regulations in their global coding and serialization project.
“We are confident that we will be able to support our customers in complying with the forthcoming U.S. requirements,” said Quick.
Growth through Acquisitions
“One of our biggest focus areas since the IPO was to expand the business through acquisitions,” Quick explained. “Our goal was to double the size of the business in five years and we are well on the track to doing that after only two. As part of this, we have had to integrate the new businesses into the Recipharm group. Now, we are pretty good at this, and in the past 12 months have brought four new companies into the group with two more announced.
“We intend to continue to grow both organically and through acquisition. Nitin Lifesciences is our first acquisition outside of Europe, which is bound to involve different challenges. But we are very hopeful that this is going to bring us a lot. For example, we will be able to offer an emerging market solution to our more developed-market customers. In addition, we see a lot of opportunity in the Indian and emerging markets in general, which we intend to take advantage of.”
Some of the company’s acquisitions include Corvette Pharmaceutical Services Group (Italy), Lusomedicamenta (EU), Flamel Technologies facility (Pessac, France), OnTarget Chemistry (Uppsala, Sweden), Kaysersberg Pharmaceuticals (Kaysersberg, France), and Nitin Lifesciences (India).
“We work to a set of values that are comprised of the following: reliability—in other words, we do what we say we will do when we say we will do it; entrepreneurship—we encourage everyone in the organization to take responsibility and try new things; professionalism—we act in a highly ethical manner; and tenacity—we don’t give up and work to solve problems,” said Quick.
As the pharmaceutical industry trends toward outsourcing, Recipharm seeks to be there to provide the solution.
“We are looking to follow a broad strategy: providing customers with a range of capabilities rather than having to go to multiple suppliers,” said Quick. “Most customers tend to want to consolidate their supplier base, so we think this is important.”