Kristin Brooks, Associate Editor10.14.14
DPx Holdings, the parent company of Patheon, DSM Fine Chemicals and Banner Life Sciences, recently acquired Gallus BioPharmaceuticals, LLC, a contract manufacturer specializing in biologics. Following the transaction, Patheon’s biologic drug substance business will have four facilities in Europe, Australia and North America, with 550 employees globally.
Gallus broadens Patheon’s process development capabilities as well as clinical and commercial scale manufacturing of mammalian cell culture derived products. With Gallus’ two sites in St. Louis, MO and Princeton, NJ, Patheon will have its first biologic drug substance sites in the U.S., in addition to its sites in Groningen, the Netherlands and Brisbane, Australia. Additionally, Patheon gains expertise in disposable technology and expands its capabilities in mid-scale flexible manufacturing.
Manja Bouman, president of Patheon’s biologics unit discusses the acquisition, expansion into commercial manufacturing, and future plans for the biologics business.
Contract Pharma: What were the key drivers behind the acquisition?
Manja Bouman: Key drivers are growth of the biologics business and biopharmaceutical manufacturing. Gallus brings commercial manufacturing expertise, a great track record, and facilities to Patheon’s existing legacy biologics entity. So it’s really an expansion of our capabilities and services.
CP: Are there overlaps between Gallus and Patheon, what areas most complement each other, and what new capabilities are gained?
MB: Gallus adds scale, capacity and commercial manufacturing expertise, as well as a presence in the U.S. market for Patheon’s biologics business. There really aren’t overlaps. We are similar businesses that are highly complementary. With the location however, the Gallus sites are an entry for Patheon’s biologics unit to gain access to the U.S. market. With a footprint in the U.S. we are very close to the majority of our biotech customers and the U.S. remains a highly driven market. Also, it brings additional capacity, scale and expertise and rounds out our existing services.
CP: How important was it to establish U.S. operations?
MB: Very important, as the U.S. is the main innovator market and a significant share of our customers are U.S.-based. The sites will be added into the network of Patheon Biologics facilities. Within the entire Patheon network, we offer drug product services, final fill of the bulk drug substance manufactured at the four biologics facilities, and then three other sites are able to take the bulk product and produce a finished dosage form for our customers. So, the facilities broaden Patheon’s network. Also, with the U.S. facilities, we now have a global footprint.
CP: With growth in biologics manufacturing, is the acquisition based on demand, the outsourcing industry maturing, or scaling up?
MB: All three! It’s also about what our customers are looking for. The skill of Gallus’ facilities is an important addition. To highlight that, there are only a few biologics contract manufacturing organizations that produce commercial products for their customers. Most of the market is in the clinical phase of manufacturing. Gallus’ St. Louis site is a commercial manufacturer and brings a track record of expertise and numerous years of experience.
The new Patheon biologics business unit is now the only player that is situated in the commercial market segment. As a result, we can offer our customers early stage development, clinical production, as well as commercial production. Additionally, we are very uniquely situated in a mid-size reactor scale (2,000 to 5,000 liters), while our commercial competitors are situated in a very large scale. We think that’s important because with all the technological advances over the past decade, particularly in cell line development and increasing expression levels, the need for that very large scale segment is becoming less and there’s an increasing demand for mid-scale size, which we now offer, quite uniquely.
CP: How important is scale for bio-CMOs?
MB: Scale is important, as a customer should be able to outsource from development up to commercial manufacturing at one CMO. The acquisition is both for scale and commercial capabilities. Gallus has state-of-the-art process development labs with high skill sets in upstream and downstream, and analytics. Gallus also has expertise in profusion and aseptic technology, as well as in single-use technologies and facilities. They are at the forefront of the biopharma manufacturing market and that’s now added into our network.
CP: Are there any future plans for the biologics business?
MB: Our immediate plans are to streamline the sites and basically make it a one-off experience for customers. We will have the same procedures at every site with tech transfer teams so the customer can have process development done in one place, and its clinical or commercial production done in another place. That’s what we will be focusing on in the very near future, as well as growing and further expanding the business into commercial manufacturing.
Gallus broadens Patheon’s process development capabilities as well as clinical and commercial scale manufacturing of mammalian cell culture derived products. With Gallus’ two sites in St. Louis, MO and Princeton, NJ, Patheon will have its first biologic drug substance sites in the U.S., in addition to its sites in Groningen, the Netherlands and Brisbane, Australia. Additionally, Patheon gains expertise in disposable technology and expands its capabilities in mid-scale flexible manufacturing.
Manja Bouman, president of Patheon’s biologics unit discusses the acquisition, expansion into commercial manufacturing, and future plans for the biologics business.
–Kristin Brooks
Contract Pharma: What were the key drivers behind the acquisition?
Manja Bouman: Key drivers are growth of the biologics business and biopharmaceutical manufacturing. Gallus brings commercial manufacturing expertise, a great track record, and facilities to Patheon’s existing legacy biologics entity. So it’s really an expansion of our capabilities and services.
CP: Are there overlaps between Gallus and Patheon, what areas most complement each other, and what new capabilities are gained?
MB: Gallus adds scale, capacity and commercial manufacturing expertise, as well as a presence in the U.S. market for Patheon’s biologics business. There really aren’t overlaps. We are similar businesses that are highly complementary. With the location however, the Gallus sites are an entry for Patheon’s biologics unit to gain access to the U.S. market. With a footprint in the U.S. we are very close to the majority of our biotech customers and the U.S. remains a highly driven market. Also, it brings additional capacity, scale and expertise and rounds out our existing services.
CP: How important was it to establish U.S. operations?
MB: Very important, as the U.S. is the main innovator market and a significant share of our customers are U.S.-based. The sites will be added into the network of Patheon Biologics facilities. Within the entire Patheon network, we offer drug product services, final fill of the bulk drug substance manufactured at the four biologics facilities, and then three other sites are able to take the bulk product and produce a finished dosage form for our customers. So, the facilities broaden Patheon’s network. Also, with the U.S. facilities, we now have a global footprint.
CP: With growth in biologics manufacturing, is the acquisition based on demand, the outsourcing industry maturing, or scaling up?
MB: All three! It’s also about what our customers are looking for. The skill of Gallus’ facilities is an important addition. To highlight that, there are only a few biologics contract manufacturing organizations that produce commercial products for their customers. Most of the market is in the clinical phase of manufacturing. Gallus’ St. Louis site is a commercial manufacturer and brings a track record of expertise and numerous years of experience.
The new Patheon biologics business unit is now the only player that is situated in the commercial market segment. As a result, we can offer our customers early stage development, clinical production, as well as commercial production. Additionally, we are very uniquely situated in a mid-size reactor scale (2,000 to 5,000 liters), while our commercial competitors are situated in a very large scale. We think that’s important because with all the technological advances over the past decade, particularly in cell line development and increasing expression levels, the need for that very large scale segment is becoming less and there’s an increasing demand for mid-scale size, which we now offer, quite uniquely.
CP: How important is scale for bio-CMOs?
MB: Scale is important, as a customer should be able to outsource from development up to commercial manufacturing at one CMO. The acquisition is both for scale and commercial capabilities. Gallus has state-of-the-art process development labs with high skill sets in upstream and downstream, and analytics. Gallus also has expertise in profusion and aseptic technology, as well as in single-use technologies and facilities. They are at the forefront of the biopharma manufacturing market and that’s now added into our network.
CP: Are there any future plans for the biologics business?
MB: Our immediate plans are to streamline the sites and basically make it a one-off experience for customers. We will have the same procedures at every site with tech transfer teams so the customer can have process development done in one place, and its clinical or commercial production done in another place. That’s what we will be focusing on in the very near future, as well as growing and further expanding the business into commercial manufacturing.