Synerlab Group CDMO: Drug Manufacturing for Clinical Trials in Europe

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

22 February, 2021

Olivier Cadiou is the Business Development Director of Synerlab Group, a European CDMO headquartered in France and specialized in the contract development and manufacturing of pharmaceutical products, medical devices, and food supplements. 

Synerlab Group’s expertise covers a wide range of finished products: solid oral products, sterile and non-sterile liquids, semi-solid products, injectable liquid and freeze-dried products.

In this dialogue with Olivier we will talk about drug product manufacturing in the context of clinical trials to be conducted within the European Union, with a focus on the particular needs and challenges faced by biotech startups planning their early stage clinical studies.

Patricio Ledesma (PL): Salut Olivier. It is great to talk to you about drug product manufacturing for clinical trials. I am thankful for your availability to speak about this topic.

Olivier Cadiou (OC): Thanks Patricio for this kind interview. It is nice to have this interesting talk and promote our recognized know-how beyond our borders. 

PL: Could you tell us about your role at Synerlab Group and provide us with an overview of your expertise in the area of drug manufacturing?

OC: My role is mainly to qualify new incoming projects, and establish relationships with new clients, in order to create a lasting dynamics between us and to increase our organic growth. 

Talking specifically about R&D activities, a few years ago our Group integrated a Novartis development site which was honored during the registration of several global blockbusters in the field of oncology. 

The plant is designed to be flexible and enable the development of pharmaceuticals from laboratory scale to semi-industrial scale, including clinical manufacturing. Development programs for new chemical entities represent more than 80% of our activity.

PL: Let’s focus on drug product manufacturing in the context of early stage clinical trials. What are your main recommendations to biotech companies planning their first clinical trials? What aspects are important in this early stage in terms of drug development and manufacturing strategy?

OC: Based on our experience the most important thing to enter in an early stage clinical trial is to target a basic formulation with a large flexibility to cover the wide dosing ranges used in the early clinical studies. For instance, a hard capsule is well indicated talking about a solid dosage form, which provides fast, flexible and significant benefits for this early stage approach.

Our development team helps clients to overcome development challenges, bring costs down and accelerate the time to clinic. 

They work to develop a reliable formulation that gives optimal clinical outcomes and which can be easily scaled in consideration of future routine production.

Last but not least, a strong knowledge of the pharmacokinetics of the different APIs is crucial. 

PL: What are the primary challenges faced by new biotechs with innovative compounds requiring drug product manufacturing for small-size clinical studies?

OC: In the early phase of drug development, it is common to have a limited amount of API available for reasons such as the complexity of its synthetic route or high manufacturing cost. 

Finding the appropriate formulation for a drug is often challenging, labor-intensive, and requires a significant amount of API.

Thus it is critical to make the appropriate technological choices with consistent impact on the API consumption. Our R&D site is sized to allow small scale batches for solid dosage forms as well as sterile forms.

PL: How does the Synerlab Group help biotech companies planning early-phase clinical studies? What is the particular value you offer to small biotech startups?

OC: Without hesitation our reactivity and flexibility.

We provide quick direct communication between the project manager and the client. We want to avoid a vertical organization, which often means a waste of time, so we put the experts of both parties in direct contact.

PL: Could you summarize the type of drug products you are able to produce? What is your particular area of expertise that makes you different from other CDMOs?

OC: We contribute with our expertise and benefit from the strength of our former Big Pharma (Novartis) specialized knowledge in solid dosage forms development (tablets, capsules, granules in sachets, pellets, retard release drugs, etc…). 

In addition, a few years ago, we extended our capacity to liquid formulation (e.g. nasal spray, syrup) and most recently to sterile forms in order to be aligned with our group capacities and capabilities from lab scale to industrial scale.

PL: European national regulatory authorities are known to be quite strict and demanding when evaluating the CMC quality documents of a drug to be used in a phase I or II clinical trial. What is your advice to write a solid IMPD? Do you provide support for IMPD writing?

OC: For sure we can provide support.

A solid IMPD is written based on strong source documentation written all through the development.

The key is to explain and justify all choices made during analytical development, formulation development, the establishment of specifications and the generated stabilities. 

European national regulatory authorities are quite strict but we constantly repeat dossiers for submission and we know how to avoid falling into traps and face challenges.

PL: Many biotech companies from the United States and Asia need to manufacture drugs to carry out clinical trials in Europe sooner or later, and this task can be kind of complex. How does Synerlab specifically assist non-EU clients planning clinical studies in European countries? Should these biotechs manufacture their drugs in their countries of origin or should they use a European CDMO instead?

OC: They definitely should use a European CDMO, Synerlab Group for instance!

On a more serious note, when one is dealing with clinical manufacturing, logistical aspects are crucial. Having a supply chain in place by bringing together a CDMO and a CRO in the same time zone is a great benefit.

PL: What are some emerging and trending innovations in the drug product manufacturing industry? Any disruptive manufacturing technologies or strategies foreseen for the coming years?

OC: A large amount of new drug molecules with varied therapeutic potentials have been discovered in the recent decade.

Yet most of them are still in developmental phase. This can be attributed to the limited solubility which governs the bioavailability of such drug molecules.

This represents one of the main challenges for formulation experts; how to overcome such issues without compromising on the therapeutic response.

PL: Finally, how would you summarize the “secret” to successful drug product manufacturing?

OC: A bit like a cooking recipe, in fact. Best ingredients aren’t all that necessary if a chef doesn’t know how to get the best flavors out of them.

We have the right ingredients with a package of modern equipment and brilliant cooks with all our expert teams!

PL: Olivier. Again, thanks so much for your time and for this interesting conversation.

OC: A pleasure to chat with you, Patricio. 


About Synerlab Group

The Synerlab Group is a European CDMO specializing in the development and contract manufacturing of pharmaceutical products for human and veterinary use, medical devices and food supplements. We also offer over-the-counter product licenses and partnerships.

For more than 45 years, we have made life easier for our customers by implementing robust and innovative solutions. We mainly develop health products for the benefit of patients. Our primary aim is to always provide relevant answers to the needs of our customers.

Our expertise spans various forms of finished products: solid oral, sterile and non-sterile liquids, semi-solids, liquid and freeze dry products. 

Our teams, expert and dynamic, are familiar with the constraints of manufacturing. They have a constant concern for improving performance. This state of mind thus constantly guarantees the excellence of the quality of our services and products.

Our 6 production sites, based in France and Spain, are organized around structures on a human scale. This allows us to offer great responsiveness and flexibility to our customers.

Through a search for continuous improvement and operational excellence, we create value for our customers, employees and shareholders and thus contribute to the well-being of the society.

For further information about drug product manufacturing in Europe, please contact us at: info@sofpromed.com 

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com