Marlene Leuenberger joined Quotient Sciences in 2024 as Vice President and General Manager of Quotient Sciences' Philadelphia CDMO facilities in Boothwyn (Chelsea Parkway) and Garnet Valley, PA. Before joining Quotient Sciences, Marlene served as Vice President of Operations and Site Head at Jubilant Cadista Pharmaceuticals and as General Manager at Catalent. Her career has also included leadership positions at Procter & Gamble, Wyeth Pharmaceuticals, and Novartis Consumer Health.  

The Garnet Valley and Chelsea Parkway sites specialize in small-molecule oral solid dose formulation development and drug product manufacturing. These facilities also have an important role in facilitating Translational Pharmaceutics® programs with our Miami, FL clinical pharmacology facility. Translational Pharmaceutics® is Quotient Sciences’ flagship offering for drug development that integrates drug product formulation and cGMP manufacturing with clinical testing, proven to save time and money in the early development of a drug. 

Under Marlene’s leadership, the Philadelphia teams are committed to delivering high-quality services for drug product formulation and manufacturing. Continue reading to learn more about Marlene and the capabilities from our two Philadelphia CDMO facilities.  

Coming up on almost a year with the company, what have been your impressions of Quotient Sciences so far?  

This is a company with such high potential. The science is strong, and the people are great to work with. I am very happy to be part of the team. 

Looking back to when you were first starting your career, was your goal to be where you are now? What was one of the challenges along the way?

Looking back, I think that when I started my career, I pictured myself in an executive position in very large company. I started my career with Procter and Gamble, so that is what I knew.  

Over the years, I learned that I really enjoy working in smaller companies where there is a bias toward action, decisions are made quickly, and everyone has a real impact on the business and for our customers.

I also really like being close to the action at the sites, so that makes me really happy in my current role; I am exactly where I am supposed to be. 

What excites you the most about the work being done at Quotient Sciences – Philadelphia right now? Is there a specific program or initiative coming to mind? 

There are two things that excite me about the work we are doing in Philadelphia right now.  

The first is that our Translational Pharmaceutics® programs are really taking off, and it is exciting to see how this approach helps our customers achieve results more quickly and efficiently.  

When it comes to Translational Pharmaceutics® programs, here in Philly, we develop and manufacture the drug product—including immediate-release and modified-release oral solid dose products. When ready, we send them to Miami to dose right on-site.

What’s especially valuable about Translational Pharmaceutics® is how quickly our teams can act on clinical data. If the team in Miami sees something during the study that calls for an adjustment to the formulation or dose, we can respond right away. There’s no jumping between vendors—it’s all one program, one team.  

The second is that we don’t have to stop with that early work: We have commercial capabilities in place, that we can see those early programs “grow up” within our sites and with our teams. It is always exciting to see a drug achieve this ultimate success. 

Quotient Sciences recently completed a project to better support highly potent APIs (HPAPIs). How do these investments enhance what we can offer clients, and are there any other projects ahead? 

Just recently, at Chelsea Parkway we completed a project converting two non-potent rooms into a state-of-the-art space that safely handles highly potent API (HPAPI) and drug products containing HPAPI up to PBLEC 4.  

The PBLEC system gives the necessary guidance to achieve the desired level of containment or control for handling specific compounds and is how we classify HPAPI products at all our facilities. We have long supported PBLEC 4 manufacturing at our Chelsea Parkway site, but recent changes allowed our teams to increase efficiency and safety while handling these materials.

Later in the year, we are looking at adding new isolator equipment that will increase our ability to handle HPAPI materials up to PBLEC 5 at Chelsea Parkway. At Garnet Valley, plans are also underway to determine next steps for our second building, which will add greater capacity.

In the meantime, we are preparing for an upcoming capability expo in May. Guest speakers will join us, and we’ll have presentations on latest research along with facility tours and networking. Prospective and current customers and industry consultants are all welcome to attend. 

The Garnet Valley and Chelsea Parkway facilities each have different focuses. How do the teams collaborate between the sites, and what can clients expect?  

Our Garnet Valley and Chelsea Parkway sites are not far from one another, which makes it easy for the teams to work together even though they’re two separate sites. This helps us stay agile, maintain continuity across projects, and deliver on our commitment to being a reliable partner.  

Across Quotient Sciences, we’ve established standard ways of working with how we approach project management for every program. So whether a program is based in Garnet Valley, Boothwyn, or in collaboration with our other sites, like our clinic in Miami, customers can expect a high-quality experience. This setup helps us stay efficient, share knowledge, and support each stage of development without unnecessary delays. 

Who is the ideal customer for a program at Quotient Sciences – Philadelphia?  

If there was an ideal customer, I’d say that it is one that is simply looking for a collaborative and integrated CDMO partner. The fact is we work with all clients, ranging from small and emerging biotech to Fortune 50 pharma.  

Our Philadelphia sites have a lot to offer as far as being able to take a molecule through all stages of development—up to and including commercial manufacturing. This is especially true for clients developing pediatric therapies and orphan drugs for rare diseases, but as a CDMO partner we support all small molecule therapeutics. 

Finally, what is one thing you wish customers knew, or better understood, about the Quotient Sciences Philadelphia sites or any of the capabilities we offer here?  

I have already mentioned my excitement for our Translational Pharmaceutics, and our ability to take a drug all the way to commercial production. So the only thing I would add is to emphasize the dedication of our people. We have a very committed team here, and our way of working is in true partnership with our customers. Each project is as important to us as it is to our customers.

I am also proud of our continued record of regulatory success. In December, we completed a successful inspection by the Chinese National Medical Products Association (NMPA), which was formerly known as the Chinese FDA. This regulatory inspection adds to our global credibility; in addition, Garnet Valley and Chelsea Parkway have also been successfully inspected by the U.S. FDA, and Chelsea Parkway by ANVISA (Brazil), the Ministry of Industry and Trade of Russia, PMDA (Japan), and European Medicines Agency (EMA).  

Chelsea Parkway also is compliant with ISO 14644-1:2015 (for the classification of air cleanliness in cleanrooms and controlled environments that is based on the concentration of airborne particles) and with ISO 14698:2003 (for biocontamination control of cleanrooms and controlled environments with a focus on monitoring and managing microbial contamination.) 

Dr. Vanessa Zann, Vice President of Scientific Consulting, Translational Pharmaceutics^® and Clinical Pharmacology USA, contributes to Drug Development & Delivery's special feature on bioavailability & solubility. 

Dr. Zann says she has seen positive results with spray dried dispersion (SDD) formulations to help enhance fraction absorbed, which in turn increases exposure. Quotient Sciences uses biorelevant dissolution to rank solu­bility-enhanced technology platforms and then selects the most promising for clinical assessment.

“Note there is often a disconnect be­tween preclinical in vivo data and clinical outcomes,” she says. “We recommend as­sessing the SDD platform initially as a sus­pension formulation, which provides gold standard data for what is likely to be achieved with a good performing SDD tablet.”

For example, Tranquis approached Quotient Sciences in the preclinical stage to help develop clinical formulations for first in human (FIH). The compound in question was a BCS II compound (poor solubility and high solubility) and had shown solubility limited exposure preclini­cally, hence an enhanced formulation was anticipated to be required to achieve effi­cacious clinical exposures, explains Dr. Zann. Quotient Sciences used an inte­grated approach for drug product devel­opment, manufacturing, and clinical testing (this is the Translational Pharma­ceutics^® platform) to rapidly identify and overcome solubility and bioavailability challenges for this compound.

Three suspension formulations were developed for assessment in the FIH: a methylcellulose crystalline (MC) suspen­sion; a spray-dried dispersion (SDD) sus­pension; and a hot melt extrusion (HME) suspension. The regulatory package was filed with 90 days stability for the SDD and HME GMP intermediates and seven days for the powder in bottle (PiB). The suspen­sion had four hours in use stability and a rinsing trial performed on each to allow total dosing volume to be 240mL. She ex­plains that the SDD and HME both showed superior dissolution to the crystalline API in a biorelevant dissolution assessment, demonstrating a spring and parachute ef­fect with reduced precipitation in the intes­tinal phase. A number of SDD suspensions were also assessed in the rat prior to the FIH but didn’t show any improvement over the MC suspension.

The FIH study started dosing SAD co­hort 1 (60mg) and 2 (180mg) with a methylcellulose crystalline suspension, which gave three-fold higher exposure than anticipated from the preclinical species. At SAD cohort 3 (540mg), the subjects were initially dosed with the MC suspension, but then returned to the clinic for dosing with the SDD and HME suspen­sions. The dose of the SDD and HME sus­pension was reduced to 180mg to ensure that the exposure caps were not exceeded due to the already higher exposure in the clinic than originally predicted. The SDD had the highest exposure showing a four-fold increase compared to the MC suspen­sion. This formulation was selected for dosing the remainder SAD and MAD co­horts.

“The Translational Pharmaceutics^® platform allowed the study not only to de­liver safety, tolerability, and pharmacoki­netic data, but also formulation selection assessment ahead of Phase II patient tri­als,” says Dr. Zann.

Read the full article on Drug Development & Delivery's website here.