Services
Overview of Baccinex’s field of activity in the context of clinical and commercial manufacturing
IMPLEMENTATION OF A PROJECT
Project management
Baccinex offers personalized and constant support to customers throughout the duration of the project. For new requests, an initial assessment including a feasibility study of the project is carried out.
From the first discussions, a dedicated project manager is allocated to the client: he/she is the client’s first and main contact for commercial and project specific aspects. The project manager serves as single point of contact and is the interface between the client and internal teams.
Baccinex’s project team is recognized for its dynamism and proactivity and calls on internal experts to provide the technical and quality support essential to the success of your project. The team demonstrates great flexibility and strong anticipation skills to fulfil project and client requirements.
Specific project management tools are used to identify and establish in detail the client’s needs.
Development activities
At Baccinex, we support our customers in the development of their products in respect of e.g. industrial transposition of processes under GMP conditions, the definition of manufacturing processes and the identification of primary packaging.
Industrial transposition in GMP conditions
For some of our clients, industrial scale production is an unknown stage in the development of their product. Baccinex, thanks to its expertise, provides technical support so that the industrial transposition is successful, and a step taken towards the start of clinical studies.
Definition of the manufacturing process
At Baccinex, our technical experts can provide their skills to adapt and optimize the process for production under GMP conditions. We support you to limit the risks by evaluating the criticality of each step.
Filter retention studies can be performed to define the appropriate membrane type and size and ensure dosage compliance while minimizing product loss. Additional studies such as validation of sterilizing filtration and extractables and leachables studies can be supported with filter manufacturers.
For lyophilized products, a freeze-drying cycle developed by our client or other service providers can be tested on a small scale using our development lyophilizer (with a surface area of 0.5 m2) before scaling-up to industrial conditions.
Choice of primary packaging
Choosing an appropriate primary packaging for the product is essential, especially when using sensitive APIs. Based on our experience we support the customer to define the packaging (stoppers and caps) in line with the specificities of his product.
Process validation
Aseptic process simulation is carried out through generic media fill tests according to the GMP requirements.
A standard process for aseptic process simulation has been defined in order to optimize the implementation of a client’s project for planning and business purpose. This standardization covers the simulation of aseptic processes for most of client’s processes.
In case of a non-covered manufacturing process, specific aseptic process simulation may however be carried out.
Fill and Finish
Manufacturing capacity
Baccinex’s facilities are equipped with appropriate equipment and the company developed the know-how to adapt to each formulation process and to produce both batches for clinical trials and commercial batches under the best conditions.
The maximum manufacturing capacities per batch per dosage form for our current manufacturing line are as follows:
No minimum batch size is imposed. We also position ourselves as specialists in the manufacturing of clinical batches from very small quantities of bulk solution (eg: 200-300ml).
Manufacturing process
We manufacture batches for the different phases of pharmaceutical development, from manufacturing under non-GMP conditions (first stage of scale-up under industrial conditions, preparation of material for preclinical studies, stability studies, etc.) to GMP manufacturing for clinical needs.
Baccinex specializes in two distinct dosage forms: liquid products aseptically filled and lyophilized products, both filled in vials.
Preparatory activities (washing, depyrogenation of vials, preparation of equipment) as well as for the formulation stages that are performed in a grade C area.
Then product is transferred to class A in B clean room environment for sterile filtration, aseptic filling and crimping.
The lyophilizer has a surface area of 3.5m2 divided into 5 shelves with a condenser of 45 kg ice capacity.
Secondary packaging
A 100% visual inspection of the units produced is carried out by rigorously qualified personnel.
Labelling can be done either manually or automatically depending on the batch size. For blinded clinical studies, randomized labelling can also be performed. We adapt to the specific needs of each client.
The majority of secondary packaging activities are carried out manually, which allows tailor-made work, both for commercial batches, as well as for specific tasks (eg: preparation of kits, etc.) for clinical trials.
Quality Control
Release testing
The activities listed below are carried out internally in our quality control laboratory:
In the event that certain analytic methods cannot be carried out in-house, Baccinex is working with qualified subcontracting analytical laboratories, capable of carrying out such analysis.
QC activities are carried out in support of manufacturing activities at all stages of manufacturing :
- Analysis of raw materials and packaging items upon receipt and then released for use.
- In Process Controls (IPC).
- Sampling of the finished product to carry out the release testing.
In addition, in accordance with GMP, verification of the applicability of analytical and microbiological methods are performed to guarantee reliable and reproducible results.
- Microbiological methods usually validated are bioburden and sterility (bioburden, sterility).
- Physico-chemical methods regularly validated are dosage and/or impurities by HPLC, endotoxins.
Finally, a method transfer can be considered in order to group all the methods on the same site.
Stability studies
Stability studies is a major activity in our QC laboratory as obtaining stability data is mandatory for development phase I and II. For commercial products, on-going stability studies are performed routinely.
Qualified climatic chambers are installed in order to store stability samples according to ICH conditions :
- -20°C ± 5°C
- 5°C ± 3°C
- 25°C ± 2°C / 60% HR ± 5% HR
- 30°C ± 2°C / 65% HR ± 5% HR
- 40°C ± 2°C/75% HR ± 5% HR
GMP batch certification
Following manufacturing and testing of the batch, the entire batch record is reviewed by internal departments as well as by the quality assurance department, then GMP certification is granted by the qualified person.
Due to its location in Switzerland, outside of EU, Baccinex is not allowed to performed EU-QP release activities for products intended for the European market. In that case Baccinex work with established partnerships with European regulatory companies that can provide this service.
Storage and shipment
Baccinex offers storage services in large storage capacities for raw materials, drug substances and finished products under GMP conditions.
The proposed storage conditions are as follows:
- Room temperature (15-25C°)
- 2-8 °C
- -20 °C
- ≤ -70 °C (for Drug Substances)
Following the manufacturing activities, in order to provide a global service to the clients, Baccinex proposes shipment activities. Baccinex entrusts this service to qualified carriers specialized in pharmaceutical temperature-controlled transportation.
We offer transport services for international shipment of samples or batches (to the customer, distribution centres, subcontract laboratories or directly to the CRO).