According to financial and business advisors, starting a new restaurant can be one of the most risky investments you can make. Most new restaurants don’t make it very long, lost in a sea of look-alikes. Unless you’re special. Unless you offer something that very few people have and do it in a way that makes your customers happy.
Offering contract manufacturing services isn’t really that much different from opening a restaurant. Provide a quality service that very few others do, deliver it in a flexible and nimble way with a focus on client service, and you’re all but guaranteed success.
Enteris BioPharma, located in Boonton, NJ has focused their efforts on microbial expression systems. In a public auction where certain of the former company Unigene Laboratories assets were sold, including the recombinant API manufacturing capabilities as well as the oral drug delivery technology, Victory Park Capital was the highest bidder and as a result they acquired the assets that were the basis for the formation of Enteris.
Brian Zietsman, Enteris’ President and Chief Financial officer commented, “After the public auctions, Unigene was left with no assets but very skilled employees, including some employees who had been with Unigene for two or three decades, who had developed the Unigene technology and who were very skilled in recombinant manufacturing. Enteris was able to attract and offer employment to a number of these employees.”
Angelo Consalvo, the company’s Director of Recombinant Manufacturing has been the one spearheading the project to bring the API manufacturing capabilities back on-line, and it has been a success. Enteris carried-out their first manufacturing campaign in the fourth quarter of 2014 and with a marketing campaign, will re-launch their recombinant manufacturing capabilities this quarter.
Consalvo adds, “Unigene had three facilities – an R&D facility in Fairfield, NJ, a corporate office and the combined solid dosage and recombinant API manufacturing facilities in Boonton, NJ. Enteris retained the manufacturing facility, taking advantage of the fact that the building met all cGMPs.”
DEFINING CHARACTERISTICS
The current and future success of Enteris lies in its ability to differentiate itself from others in the industry.
Amos Sanchez, Enteris’ Associate Director of Business Development describes the company’s focus. “What I have been telling people is that we are solely focused on microbial expression systems, where the rest of the market is using mammalian cell cultures – we are not that – we want to carve out our own niche at our own scale, which is also part of the equation.”
Consalvo describes Enteris’ unique production scale, “There aren’t many companies with 1000 liter microbial recombinant fermentation capacity in the United States who also manufacture a commercial product in the US. The majority of bioprocessing done today utilizes mammalian cell lines, to produce antibodies, antibody fragments, and antibody conjugates. We want to carve out microbial expression processes at this scale for clinical supplies through commercial manufacturing.”
Another benefit that Enteris can offer its clients is its size. According to the team at Enteris many companies are being told by larger CMOs that their projects are too small. It can be the difference between running a campaign for 25 weeks or 3 weeks. Enteris’ size offers the flexibility to handle both the smaller as well as the larger campaigns.
“Plus,” continues Consalvo, “our ability to provide services in this area without delay is appealing to many companies; as is our ability to move quickly once the project scope has been determined. Certainly this year –companies who need the manufacturing of API products can be accommodated and the combination between size and the narrow niche of microbial peptides and small proteins is really what we are looking to do.”
“We have extensive experience transferring products out of this facility,” says Consalvo. “We recently transferred a process from 1000 liters to a 10,000 liter capacity. We can do this type of sophisticated transfer.”
CLINICAL TRIAL MANUFACTURING OFFERINGS
GMP Manufacture of Tablets and Capsules
cGMP manufacturing facility
• Provision of clinical trial materials for US, EU and Rest of World
• Equipped to manufacture and package tablets and capsules from bench scale to Phase 2
• Clinical trial materials
• Capable of working with low dose / high potency APIs
• Experience with technology transfer and scale-up with multiple CMOs
ANALYTICAL DEVELOPMENT
• Analytical assay development and validation
• Evolutionary approach: phase-appropriate through NDA quality validations
• Submission quality reports
• On-site in-process control, release and stability testing
• Full support through analytical method transfer
QUALITY SYSTEMS
• Systems compliant with FDA, EMA and ICH
• Customer focused, providing real time feedback on all quality related issues
• Full project participation:
• Process development – batch record design – GMP manufacture
• Manufacturing oversight through concurrent batch record review
• Label control for blinded and open-label studies
• Vendor auditing and qualification program
“We also have experience in process validation, process characterization, and we can provide a full CMC package.”
INDUSTRY INQUIRIES
For a relatively new company, Enteris has garnered a lot attention. One of the main draws has been its location.
“One of the things that gets people’s attention is that we are here,” says Tim Saxon, Enteris’ Vice President of Business Development. “It’s been very interesting, we often talk to people and they ask where our facility is located and when we say it’s here, in Boonton, NJ they are quite surprised.”
Saxon continues, “A big draw to some prospective clients is that the company is located in the US – that is very important to people. The draw is that we are here, we offer GMP production – and then they want to send their experts out to have a look.”
LOOKING AHEAD
With most of the heavy lifting accomplished, Enteris is looking ahead to streamlining its business and offering the types of services its customers need most.
“We have two businesses going on right now – and the overlap is very slight,” says Saxon. “The overlap between the oral drug delivery business and the recombinant manufacturing business is what Unigene focused on exploiting. Oral delivery is great for small peptide drugs – but you make them synthetically. Whereas, of course, recombinant manufacturing is for the bigger molecules. If you are delivering an orally large molecule product – you get a very low bioavailability – which is fine if it works. But of course, it costs a lot more for the percentage of bioavailability you are getting.”
Saxon continues, “We want to carve out a niche of expertise for ourselves and of course foster relationships in order to keep a steady stream of clients coming through our facility.”
“We’ve used the term nimble,” says Zietsman. “We are small and are relaunching – so that for companies looking for recombinant manufacturing – we have that capacity right now. As to our advantage – we think that’s our ability to move quickly.”
