Development services to bring your product to the clinic

Small scale production & scale up | Formulation and lyophilization cycle development | Analytical development

Our development services span from small scale production of virus or protein products for evaluation of technological capabilities to process scale up for the production of TOX, clinical and even commercial batch sizes. Next to that we also provide small and larger scale production of freeze-dried product for process or analytical evaluation.

Your partner for scaling up your process from bench to industrial 1,000 L size

Your partner for scaling up your process from bench to industrial 1,000 L size

When creating a novel therapeutic, processes are typically developed at laboratory scale. These laboratory scale production processes may be sufficient for early efficacy and toxicity studies in small animals and for related pre-clinical work. However, in order to ensure that the results from these early studies can be reliably used as predictive markers for later, larger scale productions, it is important to manufacture these batches by using scalable production techniques.

When creating a novel therapeutic, processes are typically developed at laboratory scale. These laboratory scale production processes may be sufficient for early efficacy and toxicity studies in small animals and for related pre-clinical work. However, in order to ensure that the results from these early studies can be reliably used as predictive markers for later, larger scale productions, it is important to manufacture these batches by using scalable production techniques.

 

Small scale production

HALIX can produce early phase drug substance and drug product in our development laboratories. Our customizable and highly flexible way of working ensures that we can transfer your in house developed processes with a minimum of effort.

Small scale production

HALIX can produce early phase drug substance and drug product in our development laboratories. Our customizable and highly flexible way of working ensures that we can transfer your in house developed processes with a minimum of effort.

Production scale up

As you proceed to phase 1 and 2 clinical trial studies, your production needs will likely increase. In order to meet demand, your processes will need to be scaled up from laboratory scale to industrial scale. Based upon existing processes, our experts can scale up production to meet the needs of your TOX, stability, clinical and even commercial batch sizes. Depending on your specific manufacturing requirements we can also offer engineering batches and technical batches.

Production scale up

As you proceed to phase 1 and 2 clinical trial studies, your production needs will likely increase. In order to meet demand, your processes will need to be scaled up from laboratory scale to industrial scale. Based upon existing processes, our experts can scale up production to meet the needs of your TOX, stability, clinical and even commercial batch sizes. Depending on your specific manufacturing requirements we can also offer engineering batches and technical batches.

Lyophilization Cycle Development and analytical development

As lyophilization is an expensive process, it is important to develop economical freeze-drying cycles. We can support your lyophilization cycle development with our small scale lyophilizer and later on transfer our small scale lyophilization processes to the industrial sized lyophilizer in our GMP facility. We have more than a decade of experience in the development, optimization, scale-up and transfer of lyophilization processes for (bio)pharmaceutical drugs.

Furthermore, depending on your requirements for analytical development, we can perform testing in-house using a wide variety of techniques, or outsource testing to qualified contract labs.

CDMO development for virus products and recombinant proteins

Our fully licensed production facility in the Netherlands allows for flexible and scalable contract development and cGMP production for preclinical to commercial scale product and virus products. Our production capabilities cover the whole manufacturing spectrum and include:

Get in touch to discuss your project

GMP viral product manufacturing

We support you with the development & commercialization of viral products enabling the treatment and prevention of life threatening conditions.

Learn more

GMP recombinant protein manufacturing

We support you in developing and commercializing recombinant proteins and antibodies, enabling the treatment and prevention of life-threatening conditions.

Learn more

Aseptic fill and finish and lyophilization

We provide GMP certified drug product production capabilities with a small and large scale filling line, processing over a million vials per year.

Learn more

Client specific complementary services

Whether you are looking for cell bank or virus seed bank production services, regulatory support, full QC or QP services, or labeling & packaging, we are here for you.

Learn more

GMP viral product manufacturing

We support you with the development & commercialization of viral products enabling the treatment and prevention of life threatening conditions.

Learn more

GMP recombinant protein manufacturing

We support you in developing and commercializing recombinant proteins and antibodies, enabling the treatment and prevention of life-threatening conditions.

Learn more

Aseptic fill and finish and lyophilization

We provide GMP certified drug product production capabilities with a small and large scale filling line, processing over a million vials per year.

Learn more

Client specific complementary services

Whether you are looking for cell bank or virus seed bank production services, regulatory support, full QC or QP services, or labeling & packaging, we are here for you.

Learn more