October 1, 2009 (Vol. 29, No. 17)

Acquisition of Henogen Increases Company’s Biopharmaceutical Manufacturing Offerings

The raft of bioprocess and production technologies acquired by Novasep through its July takeover of Henogen means the company can now claim to offer a range of solutions for the development and potentially commercial-scale manufacture of just about any type of biopharmaceutical.

Prior to the takeover, Novasep offered downstream services for the purification and clinical-stage manufacture of biopharmaceuticals. It also offered a full suite of services for process development, separation/purification, and commercial-scale manufacture of synthetic APIs, explains marketing and business development director Jean Blehaut.

“Our acquisition of Henogen has added the upstream processes we needed to turn Novasep into a complete service provider for biopharmaceuticals as well as APIs. The upstream capabilities of Henogen for biopharma development means we now have the expertise to go from gene to GMP product for just about any biomolecule. Our own engineering expertise means we can also rapidly set up commercial-scale production if required. We believe we are now one of the few contract manufacturers worldwide able to offer a complete manufacturing solution for antibody-drug conjugates (ADCs).”

Originally founded in 1995 to offer large-scale chromatography solutions, primarily for the separation of synthetic APIs, Novasep has extended its expertise and made strategic acquisitions to meet the emerging biopharmaceutical process development and manufacturing market head on.

“Having built up our separations business during the late 1990s, we spent the early part of the new millennium answering our clients’ calls for synthetic API manufacturing solutions and built up a substantial GMP manufacturing operation,” Blehaut says.

“By about 2004, however, it became evident that drug discovery was focusing increasingly on biopharmaceuticals. While some of our chromatography technologies were well-suited to the separation of such biomolecules such as fermentation products, we again decided to go down the acquisition route and took over a couple of companies that gave us new expertise in new areas such as tangential flow filtration products.”

This still left Novasep lacking in upstream process-development capabilities for biopharmaceuticals, however. “By early 2009 we were in a similar position with respect to our service offerings for biopharmaceuticals, to the situation we had been in during the early 2000s regarding synthetic APIs,” Blehaut admits.

“We could provide state-of-the-art separation/purification technologies and had clinical-scale manufacturing capacity, but could not start further downstream to offer complete bioprocess solutions. Our acquisition of Henogen has filled this gap perfectly.”

Henogen’s scope of services ranges from the development of cell banks using various expression technologies, to the production of biopharmaceuticals for Phase III trials. Downstream capabilities include formulation and fill-and-finish services.

Operating out of two sites in Belgium, Henogen’s upstream technologies perfectly matched Novasep’s requirements, Blehaut explains. “In addition to microbial and yeast fermentation, the company also has expertise in insect and mammalian cell culture technologies for monoclonal antibody (mAb) production. Major expertise in the production of viruses and viral vectors for vaccine development is also being exploited by some of the world’s biggest vaccine players.”

As a result of the Henogen acquisition, Novasep can now conduct monoclonal antibody and toxin manufacture, conjugation, and final purification.

ADC Manufacture

Henogen’s expertise in monoclonal antibody production coincidentally fit in perfectly with Novasep’s existing facility, acquired in 2003, for the manipulation and synthesis of highly potent active ingredients. “We can now carry out monoclonal antibody and toxin manufacture, conjugation, and final purification. And while Henogen has traditionally manufactured mAbs up to clinical Phase III-scale, the potency of ADCs and hence the requirement for less drug substance means we will be able to manufacture antibody conjugates to commercial scale.”

Outsource or Insource

Novasep has always operated a client-focused business model centered on individual project requirements. “Even during the early years when our technologies were centered on separations technology, our clients had the option of either outsourcing their projects to us, or asking us to develop the technologies for them to use in-house. This business model has been maintained throughout our evolution over the last 15 years.

“Today, we can take the development of a biopharmaceutical product from the earliest preclinical stage and provide process development and support up to late-stage clinical trials. We then still offer two options. Either we can carry out large-scale biomanufacturing for the client, or we can provide all the downstream technologies they require to carry out production themselves. We believe this ability to adapt to the client’s manufacturing strategy is unique in the market.”

Novasep’s strengths in engineering means it is ideally placed to respond rapidly to commercial-scale manufacturing requirements for any biopharmaceutical, Blehaut adds. “We are about to start our first commercial biomanufacturing contract, and our expertise in engineering and scale-up means we can rapidly set up commercial-scale facilities for clients as required.”

The company already operates six FDA-approved commercial-scale manufacturing facilities for synthetic APIs, and acquisition of Henogen has added two new biopharma facilities to its own commercial-scale biopharmaceutical plant.

“Our recent acquisition has, thus far, fulfilled all our requirements to become a full-service biopharma CMO,” Blehaut says. “Specific benefits include strong expertise in vaccines, and expertise in ADCs, which have given us rare expertise in the global marketplace. We aim to grow these offerings through partnerships with clients worldwide.” 

Novasep boasts expertise in vaccines and antibody-drug conjugates, which it aims to grow through partnerships with clients worldwide.

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