What Makes a Great CDMO Formulation Team?

 “Many people think all we do is mix things to make a product.”

Deepak Thassu, LGM’s Vice President of Research and Development, and member of the Formulation Department.

That couldn’t be further from the truth. Deepak’s Formulations Team puts in a lot of time and hard work developing a formulation.

In many cases, formulation development includes complex processes – from identifying the physical and chemical make-up of the drug substance, to testing the drug’s solubility and stability, to identifying the best dosage form.

The goal of the Formulations Team is to take a drug substance and turn it into an effective drug for patients. Companies usually hire a CDMO for their formulation needs because their internal team lacks the expertise, technology or bandwidth. The goal of the Formulations Team is to take a drug substance and turn it into an effective drug for patients. Companies usually hire a CDMO for their formulation needs because their internal team lacks the expertise, technology or bandwidth.

A Peek Behind the Scenes
The LGM Pharma team’s extensive experience and diverse skillsets – combined with state-of-the-art drug manufacturing facilities – allow us to meet our clients’ unique formulation needs.

We sat down with the Formulation Team to learn more about what they do and why clients trust them with their toughest formulation challenges. In addition to Deepak, we interviewed Formulation Scientist Freddie Nails, Principal Investigator & Pilot Plant Manager Larry Dodson, and Principal Investigator Ajmal Khan. Questions and answers have been edited for clarity.

Who are you typically working with when a client signs on with LGM?

DT: For the Formulation Development Department, everyone in the company is our customer. We work with Business Affairs, Marketing, Business Development, Legal, Regulatory, and Process Development matters. It’s important to remember that we have external customers as well, including the FDA and other regulatory agencies.

Your team has more than 90 years of combined experience in pharmaceutical formulation and process development, and validation. Why is experience so critical in formulation, and how does it make LGM different?

FN: Innovation is directly proportional to experience. The more experience you have, the more historical knowledge you possess. Historical knowledge helps us to innovate, make changes and adapt. At LGM, we have a very diverse collection of people with varied experience. It’s critical to have people that have done the work, and know that they can do it in their sleep.

AK:  When you assemble a formula, you’re putting together 10 to 15 or more different things. You want to make sure that everything holds out, that your active pharmaceutical ingredient will be stable across its shelf life, and that all your excipients are going to behave the way they are supposed to behave. So that’s where you see the difference between an experienced formulator and somebody new coming into this field. You learn from experience, and every dosage form or class of compound has its unique challenges.

LD:  Due to our team’s combined experience, we can get to that final formulation a lot faster.

We know that experience is critical, but what other skills do you consider essential for a formulation development team?

AK: Perseverance. It played a big role in developing a product that had been on the bench for a long time – a dental paste intended to treat mouth ulcers. It was a difficult product, but we didn’t give up – and we eventually found a better way to do it.

DT:  Formulation Development is a complex science. It requires that you constantly learn and teach yourself new things. You should be a sponge – willing to absorb knowledge as much as possible, regardless of your age and experience. Another big part of formulation development is creating processes and using tools to communicate with clients. One example of this is our Gate System, which is designed to provide full insight into every step of the integrated process of Product Development and Regulatory Submission to our clients.

How does your scientific background influence your passions?

DT: I enjoy cooking, and often other people enjoy what I cook. I cannot think outside of the science-based approach, so I love doing things where I can apply this approach. It helps me constantly look for areas where I can improve, which makes me a better human being. Even if I’ve never done something, I embrace the challenge. I believe this attitude comes from what we do every day.

AK: I used to play in a band, and I still play the guitar. Music is my passion. In music, everything is organized. If you play in a band, teamwork becomes very critical. When I play my part, I need to make sure it matches with what the drummer is doing and what the singer is doing, etc.

LD: I think of myself as a problem solver. I think it started early in life. Growing up, my dad always worked on his car, figuring out how to fix it himself. I worked along with him, figuring those things out.  I continued fixing cars, doing construction, basically anything that presented a challenge.

FN:  I ended up getting into college with an athletic scholarship, and I decided then to apply the energy I was using on my athletic training to my education. I became a chemist and started applying the skills I learned at work in my personal life. My work has really dictated how I go about doing things in my personal life because it’s structured and organized, which provides a lot of structure and organization in my life. I enjoy cooking (BBQ) and working on cars and engine projects.

The Takeaway: Experience Matters.

When a pharma company needs formulation support, a CDMO with an experienced and diverse formulation team is a must. A team with decades of experience will understand the different ingredients and what their functions are in the formulation, whereas an inexperienced team may not even know where to start. An experienced team will also be able to apply their past experiences with similar products or dosage forms to complete formulation work quickly, effectively saving the client time and money.

The other important aspect of a formulation team is collaboration. For a project to run smoothly and quickly, it’s crucial to have a team that collaborates and communicates with each other and with other stakeholders. State-of-the-art facilities and world-class equipment are also necessary – but it’s truly the team behind the technology that matters most. LGM’s experienced team combines their unique backgrounds to work efficiently and effectively, and the results speak for themselves.

[As to the role cooking and car engine projects may play in successful formulation development, the jury is still out. But it is statistically intriguing…and it’s making us hungry!]

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