Formulation and Development of Injectable Drug Product at CARBOGEN AMCIS
In addition to Drug Substance services, CARBOGEN AMCIS is currently in an on-going growth phase of its Drug Product services capabilities. At our Saint-Beauzire (France) site, there are two state of the art sterile production lines, built and qualified according to the latest Annex 1 release. The site is also equipped with a new 350m2 development lab, divided in to two areas (analytical purposes and formulation/process development work).
CARBOGEN AMCIS can support you through the whole development journey of your new injectable Drug Product. In fact, we can offer a full formulation development service both liquid or lyophilized products. In both forms the initiation of the work will be the same.
The first step is a study, testing the impact of pH or the influence of buffers on solubility. Once the pH range is defined and the buffer chosen, we work on refining the strength of the buffer, if needed. In the case of liquid products requiring an organic formulation, a screening of solvent or co-solvent is performed.
Once the quantitative formulation has been defined and agreed upon with the client, the process development activities start. In this part of the work, we define the packaging components (vials, stoppers, caps) and the type of sterilizing filter.
In order to demonstrate that the product can only by sterilized by filtration, we can also offer to perform autoclave testing or gamma irradiation studies. During the process development step, we also verify the compatibility of the manufacturing components (tubing, bags, needles….) with the formulation.
We also perform stress studies with temperature, oxygen and light to define the formulation manufacturing hold points and times. This can also help us to define any needed flush volumes and help fine-tune the manufacturing process.
Finally, the last stage of pharmaceutical development at CARBOGEN AMCIS is the manufacture of a technical batch under non-GMP conditions. For this campaign, our industrial transfer team ensures a smooth technology transfer into production. This technical batch is generally used for toxicological studies and for stability studies. This batch can also be used to help you establish an initial retest date for their Drug Product.
In addition to our formulation capabilities, the development laboratory also has an independent analytical laboratory.
In this space, we have multiple HPLC and UPLC systems, and also use industry standard methods to analyze injectable products. With our analytical capabilities, we are able to implement and optimize assay content and purity methods. We also perform forced degradation studies to establish stability indicating methods, for analysis during development, for final release tests and stability studies.
Last but not least, our team is composed of eight expert scientists, including four laboratory technicians with extensive analytical and formulation backgrounds. They have extensive experience working in different pharmaceutical companies and on multiple pharmaceutical dosage forms.
To accompany your pharmaceutical development work, we also have four experienced project managers. They will be your main point of contact for all the development activities.
