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Formulation and Development of Injectable Drug Product at CARBOGEN AMCIS

Formulation and Development of Injectable Drug Product at CARBOGEN AMCIS

Wednesday, 04 October 2023

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.

For aqueous liquid products, once the solubility study is performed, a screening of various excipients for solubility or stability enhancement is conducted. At this stage of the process, a water-based formulation can contain buffer, solubility enhancing molecules (e.g., cyclodextrines), pH adjusting excipients, or surfactants. Based on the results obtained at this step, 2-3 lead formulation candidates are placed in a preliminary stability study, which will allow a refinement of the formulation composition, adjusting the various excipients quantities.

In some cases, this preliminary work will demonstrate a lack of robustness of the formulation against oxidation and can lead to the decision to switch from a liquid to a lyophilized formulation. In this case, further work is required to define the necessary bulking agent. Additionally, a cryo-protectant may also be required. During all our Drug Product formulation development work, a quality by design approach is used to define the exact quantity of each excipient required in the formulation. This approach is detailed in the development report that you can use for your regulatory submission.

Drug Product process development: a crucial step

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.

Final step: technology transfer and technical batch

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.

To complement our standard analytical capabilities, we have additional instrumentation, such as a particle size analyzer. This apparatus is of great help for the development of nanoparticles or liposomes and can also be used for the formulation development of ADCs. Finally, we are currently qualifying a Lighthouse Oxygen Analyzer for oxygen level measurement in lyophilized products. This technique will be a great asset to understand the link between tightness of packaging components and possible degradation of the product.

Our full-service offering also includes stability in use studies, where we mimic the sample preparation and administration as it will be performed at the clinic. This final study enables you to deliver a safe and accurate pharmacy manual your clinicians. In addition, this in-use data can be used for regulatory submissions.

A team of experts with solid experience

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.

CARBOGEN AMCIS is your privileged partner for your Drug Product development. In addition we can help you to move your project forward to clinical or commercial phase.

Article by Caroline Ailhas, Project & Pharmaceutical Development Director – Saint-Beauzire

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