Tag: interview

Interview with our Formulation Project Manager – Tamas Kiss PhD

What kinds of products or projects are you mainly working on at the moment?

Most of the projects I’m working on are confidential. Still, I can say that we’re involved in multiple formulation development programs for pharmaceutical products, including ocular, parenteral, and oral dosage forms, which I help coordinate. I’m also responsible for some internal pipeline projects that we’re developing in-house.

How are cyclodextrins usually used in your formulations — is it more for solubility, stability, or something else?

You’re right — cyclodextrins are primarily used for improving solubility and stability. But they also offer several other benefits due to their ability to form inclusion complexes with parts or even the whole molecule. For example, they can mask unpleasant taste or odor, and they can interact with cholesterol in biological membranes, which in turn may enhance the permeability of certain APIs, especially those in BCS Class III or IV.

What’s the most challenging part of developing cyclodextrin-based formulations?

One of the main challenges is that only a limited number of cyclodextrins are approved for most administration routes, so you can’t just choose any cyclodextrin for a given formulation. You must be very careful when selecting excipients. That’s where expertise really matters — having a solid understanding of the regulatory landscape can save a lot of time and effort by avoiding unnecessary studies.

What does a typical project timeline look like, from idea to client delivery or product transfer?

I’d say we’re quite agile — after the initial consultation with a client, we typically prepare a detailed work proposal with pricing within about two weeks. This timeline can be longer if we need to outsource specific tasks, for example, when handling highly potent APIs. Project durations vary depending on complexity, but most run between 4 and 40 weeks. The number of experimental iterations and the duration of stability studies are key factors that influence the overall timeline. If the formulation performs as expected, we need a few additional weeks for tech transfer so it can be manufactured at scale under GMP conditions.

Do you also get involved in discussions with partners or clients about new projects?

Yes, I’m involved in discussions with clients at the early stage of several parallel projects, even before the actual work begins. From there, I take on the coordination role — which doesn’t necessarily mean doing the lab work myself, but instead planning and overseeing activities based on the agreed timeline, scope, and budget and being the link among the stakeholders. In the projects I manage, I’m also responsible for summarizing the results and conclusions in a final report for the client.

What do you enjoy most about working there so far — scientifically or otherwise?

What I enjoy most is working on several projects in parallel and organizing my tasks effectively. I like using tools that help me stay on top of things. I also really enjoy deepening my knowledge in the pharmaceutical field. Over time, I’ve come to understand regulatory thinking better, and I feel I’m continuously improving in managing R&D projects. Additionally, I’ve recently taken on business development responsibilities in the cosmetics sector, which is an entirely new endeavor for both me and the company. It’s a big challenge, but one I find really exciting. Besides, I am responsible for the intern at our company, I enjoy mentoring him.

Where do you see the company’s biggest opportunity for growth in the next couple of years?

I think the company’s most significant opportunity lies in the success of multiple pipeline projects, not just one standout, but several. If these milestones are reached, it will significantly increase our visibility in the industry. Beyond our current revenue streams from grants and CRO-type services, generating income from our pipeline assets would dramatically strengthen the business model, providing us with greater independence and recognition.

Interview with Tamas Sohajda, CEO of CarboHyde

1) You have extensive experience with cyclodextrins. What inspired you to co-found CarboHyde and focus on this niche area?

Cyclodextrins and marvelous molecules that offer much more today as they did 20 years ago. Solubilization and stabilization of small molecules are still there, but innovative applications really bring light to research. Today, we can stabilize proteins, use them as cryoprotectants in vaccines, purify air or water, deliver genes, keep food fresh and so much more. Not to mention potentially treat at least a dozen diseases. This broad range of innovative applications is so suggestive that we could not resist building a company specialized in cyclodextrin to help innovations get to the market.

2) Can you elaborate on CarboHyde’s approach to developing carbohydrate-based APIs and its focus on rare diseases and RNA delivery systems?

In both cases, we start from cyclodextrins, yet the chemistry gets different immediately.

For gene delivery, we create amphiphilic molecules that are capable of nanoparticle formation (similarly to LNPs), encapsulate and deliver oligonucleotides to cells.

In the Active ingredient projects, we focus on correcting the “excipient-like” features of cyclodextrins and making them more ‘drug-like”, with improved efficacy, PK/PD profile, cell targeting and so on.

3) Your pipeline includes innovative platforms for gene delivery and vaccine applications. Could you share recent breakthroughs in these areas?

The gene delivery is rather an early stage, we are still exploring the preclinical feasibility of the project, yet I can say that the transfection efficacy of cyclodextrin-based systems is compatible with LNPs, while their application range seems to be much wider.

In vaccines, the two most recent breakthroughs are the application as a cryoprotectant (JJ’s covid vaccine) and their use as a new, safe class of vaccine adjuvants (currently in clinical phases)

4)  What makes your cyclodextrin-based non-viral gene delivery system stand out from other technologies?

We are still exploring the answers to this question. Cyclodextrins – including the ones we developed for this purpose – have a superior safety profile and are very well tolerated by the human body. We expect that side effects originating from the use of other encapsulation techniques could be eliminated if cyclodextrin-based DDSs were used instead.

5)  CarboHyde emphasizes collaboration and sustainable growth. How does this philosophy influence your long-term strategy?

This is the core of our strategy. CarboHyde while young is built to be a long-lasting, legacy-building company. We believe in the present and future of cyclodextrins and are passionate about contributing to their growing success for the benefit of patients and mankind as much as we can.

And this is not a marketing talk. For us, it matters little if a great idea comes from us or someone else. We do not see the business in it, but the opportunity and challenge of creating something good. So if we can help with our expertise to make that happen, we will, irrespective of our business involvement in the project.

6) By 2027, you aim to sponsor early-stage clinical trials and hold multiple patent families. How are you progressing toward these goals?

I think we are on a good track. Our most advanced collaborative asset, KS-01 can be dosed to breast cancer patients if all goes well as early as 2026. Regarding patents, we are also on track, with the first 2 families filed/getting filed these weeks. It is no secret that at CarboHyde, our expertise is closer to CMC, especially preclinical CMC. While we have moonshot dream, we stand with two feet on ground and know that there are areas where we need external help and clinical design, and regulatory strategy are those areas.

7) Cyclodextrins have wide-ranging pharmaceutical applications. How do you see their role evolving in global drug development?

Most certainly. When we look at current commercial applications, 95% we see small molecules formulated. While this is also a growing trend with 130+ products on the market currently, I expect several monoclonal antibodies and vaccines to be marketed in the coming years where cyclodextrins are part of the formulation. I also believe that they will expand in the active ingredient and gene delivery / cell therapy space, but those have longer timelines.

8) You have collaborated with academic and industrial partners extensively. What has been the most rewarding aspect of these partnerships?

We are learners. I particularly enjoy discussing wild ideas with new people, brainstorming about impossible projects, and exploring untouched areas. We can only grow when we get out of our comfort zone. These partnerships help a lot with that when they inspire us to look beyond what we know already.

9) What motivates you most about working in this field?

There have been no new cyclodextrins introduced to commercial applications for almost 20 years now in pharma. I believe we have everything at CarboHyde to make a new milestone on that path and will persistently towards that goal.

10) How do you see CarboHyde contributing to the broader pharmaceutical and biotech landscape in the coming decade?

Broader landscape? Realistically, I do not believe that cyclodextrins have a high chance of being a groundbreaking innovation in pharma in the coming decade. Yet I strongly believe that we can develop a few new very smart drugs like Sugammadex, alternative tools for the delivery of biologicals or simply improve the performance of some products with a little cyclodextrin spice.

Also, I believe that cyclodextrins are underrecognized and their vast potential is not known enough, neither in pharma, nor other industries. Maybe our biggest impact in the coming years will be to change that.