Aseptic Fill and Finish and Lyophilization
Clinical and commercial drug product | Lyophilization cycle development | Labeling and Packaging
We are specialized in aseptic fill and finish and lyophilization of drug product manufacturing from clinical to commercial scale. We offer a large variety of services spanning from lyophilization cycle development, small and large-scale aseptic fill and finish, to freeze drying and packaging.
Fast and flexible services from clinical to commercial volumes
We offer GMP-certified aseptic filling and lyophilization and process over a million vials per year. Using a modern automated filling line under grade A in grade B clean room conditions, we can handle liquid packaging solutions, from 2 RDIN up to 50 ml vials, with batch sizes varying from 100 to 20,000 vials per batch. Unique coding on the aluminum cap of the vials makes every vial identifiable.
Aseptic fill and finish of drug product from clinical to commercial scale
Fill and finish is the final manufacturing step in creating an aseptic drug product. Aseptic liquid filling requires highly technical driven processes to ensure a sterile and safe product is administered to the patient.
We provide GMP certified production capabilities with an automated filling line, processing over a million vials per year. For viral biological products that require BSL2 conditions, we provide manual filling. We can further complement the fill and finish activities of your drug product with customized labelling and packaging.
Production parameters:
Our pilot freeze dryer has a 0.5 m2 plate and is typically used for lyophilization cycle development programs. With our 5.0 m2 plate capacity in the commercial lyophilizer, we can process batches up to 20,000 vials. The GMP certified freeze dryer can create lyophilized vials for our complete validated range.
Our fill and finish offering:
We start with a technical assessment of your manufacturing project and transfer your needs into our production process or into the setup of our facility. All filling activities are subject to visual inspection and comply with EMA requirements for GMP manufacturing. The HALIX service package offers 100% visual inspection, labelling and packaging, and QP batch certification. Depending on our client’s situation and preferences we offer a highly flexible package of services and adapt them individually to your requirements.
Freeze-drying and lyophilization cycle development
HALIX can support you in development and improvement of a lyophilization (freeze drying) cycle for biopharmaceutical products. By performing runs with a small amount of material, with a lyophilization cycle proposed by our freeze-drying experts, we can design and/or optimize your lyophilization process.
In a later stage the cycle can be scaled up easily from lab-scale to full scale lyophilizer to be directly implemented for your clinical and commercial scale batches. Parameters set in the pilot freeze dryer therefore also apply in the industrial freeze-dyer.
Lyophilization Cycle Development
As lyophilization is an expensive process, it is of high importance to develop economical freeze-drying cycles suitable for larger-scale production of the product. We are experienced in the development, optimization, scale-up and transfer of lyophilization processes for (bio)pharmaceutical drugs.
For the lyophilization cycle development appropriate process parameters will be identified and optimized: freezing conditions, freezing rate, shelf temperature during freezing, duration of the freezing step, primary and secondary drying conditions, shelf temperature and pressure.
Production parameters
Our pilot freeze dryer has a 0.5 m2 plate and is typically used for lyophilization cycle development programs. With a 5.0 m2 plate capacity in the commercial lyophilizer, we can process batches up to 20,000 vials. We can then perform fill and freeze directly after filling as we have an industrial vacuum dryer linked to our automated filling line. The GMP certified freeze dryer can create lyophilized vials for our complete validated range.
Labeling and packaging for your drug product with custom layouts and randomization
Current GMP guidelines including EC directive 2011/62/EC and the Falsified Medicines Directive (FMD) contain specific requirements for the labeling and packaging of pharmaceutical products. Each vial should be clearly and unambiguously labelled and packed in tamper evident packaging. Full reconciliation and traceability of materials is required to avoid any risk of mistakes. This is therefore a highly specialized task, requiring well-established procedures to ensure the highest level of compliance.
In the case of clinical trial material where a double blind comparison is made, randomization and blinding may be needed to ensure unbiased results.
HALIX full service offering
We offer state-of-the-art vial labeling and packaging with custom layouts and full blinding and randomization where required. If you have specific wishes for primary packaging, HALIX can perform machinability testing with your preferred vials and caps on our filling line. Alternatively, we offer a validated range of standard primary packaging. With this broad range of vial sizes in primary packaging most requirements of our clients can be met.
Our labeling and packaging service includes serialization by adding a unique identifier each pack to allow verification of authenticity and identification of individual units. We can support the design process of your secondary packaging, creating artwork that meets your regulatory requirements and can be reviewed by our QPs. Branding elements can be created that fit your communication strategy, or fit the application mechanism for your drug product.
- Overview of fill/finish and lyophilization capabilities
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- Aseptic fill and finish
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Aseptic fill and finish of drug product from clinical to commercial scale
Fill and finish is the final manufacturing step in creating an aseptic drug product. Aseptic liquid filling requires highly technical driven processes to ensure a sterile and safe product is administered to the patient.
We provide GMP certified production capabilities with an automated filling line, processing over a million vials per year. For viral biological products that require BSL2 conditions, we provide manual filling. We can further complement the fill and finish activities of your drug product with customized labelling and packaging.
Production parameters:
Our pilot freeze dryer has a 0.5 m2 plate and is typically used for lyophilization cycle development programs. With our 5.0 m2 plate capacity in the commercial lyophilizer, we can process batches up to 20,000 vials. The GMP certified freeze dryer can create lyophilized vials for our complete validated range.
Our fill and finish offering:
We start with a technical assessment of your manufacturing project and transfer your needs into our production process or into the setup of our facility. All filling activities are subject to visual inspection and comply with EMA requirements for GMP manufacturing. The HALIX service package offers 100% visual inspection, labelling and packaging, and QP batch certification. Depending on our client’s situation and preferences we offer a highly flexible package of services and adapt them individually to your requirements.
- Lyophilization
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Freeze-drying and lyophilization cycle development
HALIX can support you in development and improvement of a lyophilization (freeze drying) cycle for biopharmaceutical products. By performing runs with a small amount of material, with a lyophilization cycle proposed by our freeze-drying experts, we can design and/or optimize your lyophilization process.
In a later stage the cycle can be scaled up easily from lab-scale to full scale lyophilizer to be directly implemented for your clinical and commercial scale batches. Parameters set in the pilot freeze dryer therefore also apply in the industrial freeze-dyer.
Lyophilization Cycle Development
As lyophilization is an expensive process, it is of high importance to develop economical freeze-drying cycles suitable for larger-scale production of the product. We are experienced in the development, optimization, scale-up and transfer of lyophilization processes for (bio)pharmaceutical drugs.
For the lyophilization cycle development appropriate process parameters will be identified and optimized: freezing conditions, freezing rate, shelf temperature during freezing, duration of the freezing step, primary and secondary drying conditions, shelf temperature and pressure.
Production parameters
Our pilot freeze dryer has a 0.5 m2 plate and is typically used for lyophilization cycle development programs. With a 5.0 m2 plate capacity in the commercial lyophilizer, we can process batches up to 20,000 vials. We can then perform fill and freeze directly after filling as we have an industrial vacuum dryer linked to our automated filling line. The GMP certified freeze dryer can create lyophilized vials for our complete validated range.
- Labeling and packaging
-
Labeling and packaging for your drug product with custom layouts and randomization
Current GMP guidelines including EC directive 2011/62/EC and the Falsified Medicines Directive (FMD) contain specific requirements for the labeling and packaging of pharmaceutical products. Each vial should be clearly and unambiguously labelled and packed in tamper evident packaging. Full reconciliation and traceability of materials is required to avoid any risk of mistakes. This is therefore a highly specialized task, requiring well-established procedures to ensure the highest level of compliance.
In the case of clinical trial material where a double blind comparison is made, randomization and blinding may be needed to ensure unbiased results.
HALIX full service offering
We offer state-of-the-art vial labeling and packaging with custom layouts and full blinding and randomization where required. If you have specific wishes for primary packaging, HALIX can perform machinability testing with your preferred vials and caps on our filling line. Alternatively, we offer a validated range of standard primary packaging. With this broad range of vial sizes in primary packaging most requirements of our clients can be met.
Our labeling and packaging service includes serialization by adding a unique identifier each pack to allow verification of authenticity and identification of individual units. We can support the design process of your secondary packaging, creating artwork that meets your regulatory requirements and can be reviewed by our QPs. Branding elements can be created that fit your communication strategy, or fit the application mechanism for your drug product.
Case study: drug product
High quality and flexibility to support cGMP drug product
Supported aseptic fill and finish, testing, and packaging of T-Guard
Provided material on time and within budget for clinical trial
Effectively met deadlines and overcame challenges through close collaboration
“When we were looking for a CDMO partner to support the aseptic fill and finish activities, testing, and packaging of our lead compound with reliability and expertise, HALIX was the perfect fit. HALIX offered a full service to match our needs and provided us with the flexibility and collaboration that was necessary to deliver T-Guard® to clinical trials. HALIX’s attention to detail and close, transparent communication enabled us to meet our deadlines, successfully overcome challenges, and ensure the success of the project.”
Dr. Ypke van Oosterhout, Founder and CEO at Xenikos