A CDMO with Forensic Insight

“Juniper Pharma Services was initially born as Molecular Profiles back in the late 90s,” said Claire Madden-Smith, BSc PhD, Senior Vice President, Juniper Pharma Services. “It was founded to take some higher-end analytical tools to understand how and why formulations were working and how and why formulations were failing.”

A subsidiary of Juniper Pharmaceuticals, Juniper Pharma Services is a contract development and manufacturing organization (CDMO) based in Nottingham, UK that produces oral and topical drug products for clinical trials, supporting pharmaceutical and biotechnology companies worldwide.

“We were able to look at the properties of formulations in a way that wasn’t at that point in time standard in the pharmaceutical industry,” she continued.

In the late 90s and early 2000s, CDMO Juniper Pharma Services provided forensic insight into drug formulations for Big Pharma and drug delivery companies. As the company grew, it provided a greater array of analytical technology, such as chromatography, to complement its work—which primarily revolved around helping clients to better understand their formulations.

“We weren’t at that point providing the actual tablet/capsule/finished dosage form. And we saw that there was a growing need for early clinical formulation development where we could provide that finished dosage form,” said Madden-Smith. “We started on a journey of building out the facility, the knowledge-base, the staff of formulators, [the] quality system—bringing that all to bear. That’s what we’ve been doing over the last six or seven years now.”

An Unexpected Journey

“We were approached in the early days by a law firm in 1999 to see if we could help with regards to some patent litigation within the pharmaceutical industry,” said Madden-Smith.

At the time, the company had gained a reputation for being a group that could understand how and why formulations were working through investigating physical, chemical, and solid-state properties of finished dosage forms and identifying not only what and how much is there but the visualization of the physicochemical structure of the formulation.

“Not many people were doing this, which could visualize very complex data in a meaningful way, allowing you to really understand what was happening and what was happening where within your formulation. That was a step forward within the industry in the 90s and early 2000s,” said Madden-Smith.

Unbeknownst to them, that inquiry in 1999 turned out to be the world’s largest pharmaceutical litigation: a case involving AstraZeneca’s Prilosec.

A proton pump inhibitor, the heartburn treatment was one of AstraZeneca’s best-selling drugs at the time. With the drug’s patent set to expire in 2001, the company sought continued exclusivity as the generics were soon to enter the market. AstraZeneca filed litigations against the generic manufacturers, claiming that the ANDAs the companies filed infringed upon one or more of AstraZeneca’s patents.

“We ultimately went on and did all of the analytical testing to see whether there was a scientific rationale for infringement of AstraZeneca’s formulation patent,” said Madden-Smith. “That really opened up another avenue of work for us.”

Juniper Pharma Services Formed

“Over the years, we were retained by pharmaceutical companies, large pharma, and generic companies to help them to establish their intellectual property position with regards to products that were on the market,” said Madden-Smith. “By about 2010, we had from a legal standpoint worked on over half of the world’s top-selling products at that point in time in terms of helping companies to understand the legal position.

“That was quite unique. There were not many contract companies out there [at that time] that were able to deliver that very high level of work essentially into a courtroom.”

“At the end of the day, you could classify us as experts in understanding formulations all the way down to the nano and micro scale,” said Nikin Patel, PhD, MRPharmS, President, Juniper Pharma Services.

In 2013, the company brought online an expanded GMP facility in Nottingham. During that same year, the team was approached by a company in Boston called Columbia Laboratories, which had a number of successful products on the market and specialized in women’s health. Crinone, a vaginal gel that contains progesterone and used in fertility treatments, was one of the company’s main products at the time.

“They approached us because they had an issue with a product of theirs,” said Patel. “They needed our help in terms of improving the product and eliminating some of the issues they were having during the manufacturing process. So, we started working on the product. As we got to know the company, it really made sense to combine and bring the two companies together. It was a good rationale for it.”

Patel adds that, as a company, they wanted to move into the U.S. to expand their geography. Within six months, the transaction was completed and the two companies— Columbia Laboratories and Molecular Profiles—became effectively known as Juniper Pharma Services (or Juniper Pharmaceuticals).

The parent company is headquartered in Boston, but the services business is based in Nottingham.

Finding Their Niche

With nearly two decades of experience and expertise in drug development, Juniper Pharma Services has over 120 employees at its Nottingham facility and relies heavily on its formulation expertise roots.

“I think it’s really about the ability to understand the formulations—that question of how and why they’re working. The ability to understand down to that detailed level can underpin the approach of our development activities for our clients,” said Madden-Smith. “It gives us the ability to already know the avenues to avoid in development. . . . We are very well-placed to go back to our roots and seamlessly (as part of our service) provide those work arounds and the right way forward.

“So, for us, a problem is just something that’s waiting to be solved.”

As a CDMO, the programs Juniper receives are in varying stages of development. Juggling from 40-50 ongoing projects at any given time, the company is able to adapt to a variety of manufacturing activities and challenges.

“A lot of our clients today come to us where they have some form of a challenge,” said Madden-Smith. “It might be that they have a water-soluble molecule (an API) that they need to develop and gain a decent level of bioavailability. It may be that they have a very short timeframe within which to progress to clinical trials or to try to progress to commercial product. And what we’re able to do with that background that we’ve had and the skill and the breadth of the teams that we’ve brought on board is to bring a cross-disciplinary team together to find solutions for the challenges that our clients are facing, and try to bring that scientific approach to delivering those solutions for our clients.”

The company focuses on oral dosage forms for small molecules and peptides, which can be anywhere from NCE development to reformatting or repurposing existing drug molecules. They can work with solid, semi-solid, and liquid oral dosage forms (including tablets, capsules, solutions, and powders) and have a topical formulation capability.

“Where we don’t [currently] work or have capabilities in are more of the parentals and steriles areas (or things like patches, for example),” said Madden-Smith.

A Unique Approach to R&D

“We always look for where the potential gaps are in the knowledge,” said Madden-Smith, explaining that the company first addresses hurdles upfront in order to eliminate ‘dead avenues,’ or the roads that lead to nowhere. By excluding those quickly, they are able to identify development pathways that will take a product more robustly into clinic.

“We’re looking at building a development plan for our clients very quickly where our aim is to get them into clinic where they’re not failing due to inadequacies of the formulation. If you’re going to fail, fail because it’s never going to be the right product,” Madden-Smith continued. “That requires us to prove tried and true techniques.”

Not only does the company have a staff intimately familiar with formulations, but they have also formed alliances with other companies in order to more collaboratively look at chemical and biological properties as well as pharmaceutics.

“We’re giving that holistic, upfront gap analysis,” said Madden-Smith. “Then, either ourselves or the relevant experts through some of our collaborations can rapidly fill those gaps and do some initial screening-type work—which allows you to then compose the best pathway forward in terms of the next steps in development (and ultimately in processing and manufacturing).

“That seems to be an approach that is working well. The benefits are understood by our client base and the results are proving effective.”

The company has also made recent investments, including a new roller compactor as well as hot melt extrusion and spray-drying equipment, and work at a 50- to 100-kilogram batch scale.

“We take a very holistic approach [to R&D],” said Madden-Smith. “When a team is put together to deliver our client’s project, it’s a cross-disciplinary team. It’s not one department handing off to the next. We work in an integrated way to ensure that we are delivering the best that we can and hopefully the best formulation that we can achieve for our clients.”

Continuing to Grow

“As a growing business, we’re always looking at opportunities both organic and inorganic. At the present moment, what’s key for us is maintaining this growth while still delivering a high level of service,” said Patel.

Although Juniper currently doesn’t work in the commercial area, the company continues explore opportunities for growth.

“There’s a number of things that make a company successful. One of which is the people and team,” said Patel.

“I think we stand out in that we really care about what we’re trying to deliver for our client. We have an approach that we feel is [not only] grounded in good science, but it’s pragmatic to the needs of the client. We are always listening to what our client needs to get done, by when, and what their motivations and reasons behind that are,” said Madden-Smith. “We are still of that size where we’re small enough to care about getting our clients’ products through to that next stage. That is something that if we continue to grow, we want to maintain as part of the core of our service.”

This cover story can also be found in the January/February issue of Pharmaceutical Processing.

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