Bertin Pharma Interview
|Meet the Sponsors
– Bertin Pharma
Q. What are the most common challenges and problems that your partners come to you with?
A. Up to 70 percent of the drugs entering development possess insufficient aqueous solubility for adequate and consistent gastrointestinal absorption. These molecules consequently exhibit poor bioavailability, significant food effects and high inter-subject variability in vivo, necessitating the requirement for enabling formulation technology in order to give the molecule the best chance of achieving the target product profile. It is particularly true for most of anticancer drugs and hormonal entities.
Also, our partners aiming to develop new medications including biologics are often limited by the specificity of analytical techniques and procedures to characterize such products during formulation and to check the safety and the stability of the finished product.
At last we are often involved in life cycle management strategic discussions and projects for which the requirements are usually specific including generally the improvement of sensorial attributes of the drug. We must be creative but also in accordance of the needs of the patient.
Regarding paediatric drugs, adequate patient acceptability is key to drug efficacy and safety. For generations, it was considered that young children would best be treated with oral liquid formulations, as these were easy to swallow and would provide adequate dosing flexibility. However, the use of oral liquids may be associated with numerous problems, including bad taste, limited chemical, physical and/or microbial stability, risk of errors when measuring the dose…. Thus Bertin Pharma has developed specific innovative formulations dedicated to paediatric drugs such as for example, small tablets (also referred to as minitablets). This pharmaceutical form may be considered as a measure to improve acceptability and dosing flexibility in children, as several tablets can be taken as a single dose.
Q. What current solutions offer the most promise of overcoming these challenges?
A. Bertin Pharma has developed a dedicated approach for the formulation of poorly soluble drugs based on a decision tree taking into account the physical and chemical characteristics of the drug. Different solutions can be proposed based on our strong know-how involving dedicated tools and technologies specifically developed on this purpose. Moreover, as these APIs are very often anticancer or hormone products, Highly potent drugs can be securely handled in our laboratories since more than 15 years.
As for biologics formulation development, the access to a unique platform for biologics characterization (the best equipped in Europe) and our strong expertise in immunology contributes to the success of all of our customers’ projects in this field.
Our high tech laboratory located near Bordeaux and dedicated to consumer health drug products offers a strong experience in taste masking and sensorial attributes improvement and propose innovative technologies.
Q. What new technologies and processes on the horizon are you most excited about seeing developed further?
A. Development of a new drug molecule is expensive and time consuming. Improving safety efficacy ratio of “old” drugs has been attempted using different methods such as individualizing drug therapy, dose titration, and therapeutic drug monitoring. Delivering drug at controlled rate, slow delivery, targeted delivery are other very attractive methods.
Our technology DualTab™for example, is very promising in the field of consumer healthcare products but also in a wide range of therapeutic areas involving bimodal release. Several product developments are in progress using this technology.
Moreover, worldwide biopharmaceutical research companies are using biological processes to develop more and more medicines and vaccines targeting many diseases to treat, prevent or diagnose them. These biological products must be monoclonal antibodies, vaccines, blood products, gene and cell therapies. These medicines represent cutting-edge research in which the latest scientific discoveries are translated into novel therapies that provide new treatment options for patients.
Bertin Pharma is involved in smart vaccines and cell & gene therapies development through partnering and different projects that are currently conducted. Actually, in the domain of biologics Bertin Pharma offers of course pharmaceutical development services but also a strong expertise in immunology using advanced technologies available on its high tech platform.
Q. What do you hope delegates will learn about Bertin Pharma while at the DDF Summit this year?
A. We hope they will discover what makes the difference in Bertin Pharma’s pharmaceutical development approaches. Actually, we do not simply offer services, but tailored and unique solutions to fulfil our customers’ needs.