Pre-clinical manufacturing | Clinical and commercial manufacturing | Analytical and Regulatory services Viral vectors are a proven approach that is increasingly being used in oncolytic immunotherapies, cell and gene therapies, therapeutic and prophylactic vaccines. When it comes to their manufacturing, you need a CDMO with the expertise and infrastructure to scale viral vector manufacturing, produce high yields , and provide you with your product within budget and on time . Explore HALIX's track record and viral vector manufacturing capabilities below. Preclinical viral vector manufacturing Our pre-clinical viral vector manufacturing activities are geared towards process transfer, development, and supporting scale-up for eventual GMP manufacturing. Through small scale process confirmation runs and full scale engineering demonstration runs , we can produce material for pre-clinical non-human use to support formal toxicology studies, analytical development, phase appropriate analytical method qualification or validation, reference standards, as well as stability studies. These data can then be used to support definition of IND / CTA CMC content. Clinical viral vector manufacturing We perform the cGMP manufacture of viral vector drug substance and drug product for all phases of clinical trials (phase 1 - 3), meeting regulatory compliance globally. Cell and seed banks Bulk viral vector drug substance Commercial viral vector manufacturing We are GMP licensed and approved by the Dutch regulatory authorities (IGJ), in accordance with EMA, for the manufacture of drug substance and drug product batches used for commercial (licensed product) purposes. Next to that, we also provide the full scope of process validation and support studies using validated analytical methods, to support your product licensure applications (BLA, MAA, etc.). Cell and seed banks Bulk viral vector drug substance We are continually expanding our internal analytical development and quality control (QC) capabilities, providing analytical support to our client's projects. Analytical methods are then qualified and validated according to the phase of clinical development & regulatory expectations, to perform QC release and stability testing. If necessary, we will outsource analytical testing to a panel of qualified vendors under our quality management system and report the results on a certificate of analysis. Preclinical viral vector manufacturing Our pre-clinical viral vector manufacturing activities are geared towards process transfer, development, and supporting scale-up for eventual GMP manufacturing. Through small scale process confirmation runs and full scale engineering demonstration runs , we can produce material for pre-clinical non-human use to support formal toxicology studies, analytical development, phase appropriate analytical method qualification or validation, reference standards, as well as stability studies. These data can then be used to support definition of IND / CTA CMC content. Clinical viral vector manufacturing We perform the cGMP manufacture of viral vector drug substance and drug product for all phases of clinical trials (phase 1 - 3), meeting regulatory compliance globally. Cell and seed banks Bulk viral vector drug substance Commercial viral vector manufacturing We are GMP licensed and approved by the Dutch regulatory authorities (IGJ), in accordance with EMA, for the manufacture of drug substance and drug product batches used for commercial (licensed product) purposes. Next to that, we also provide the full scope of process validation and support studies using validated analytical methods, to support your product licensure applications (BLA, MAA, etc.). Cell and seed banks Bulk viral vector drug substance We are continually expanding our internal analytical development and quality control (QC) capabilities, providing analytical support to our client's projects. Analytical methods are then qualified and validated according to the phase of clinical development & regulatory expectations, to perform QC release and stability testing. If necessary, we will outsource analytical testing to a panel of qualified vendors under our quality management system and report the results on a certificate of analysis. cGMP viral vector production services and capabilities Our fully licensed production facility in the Netherlands allows for flexible and scalable contract development and cGMP production from preclinical to commercial scale products. Our production capabilities cover the whole manufacturing spectrum and include: COMPLIANCE AND QUALITY We support you in developing and commercializing recombinant proteins and antibodies, enabling the treatment and prevention of life-threatening conditions. HALIX B.V. Tinbergenweg 1, 2333 BB Leiden, The Netherlands
Clinical (Phase I-III) manufacturing
onbekend
| Functietitel | Process Development Engineer |
| Indicatie salaris (min – max] | onbekend – onbekend |
| Opleidingsniveau | HBO |
| Aantal uren (min – max) | 1 – 40 |
| Contactgegevens | onbekend , onbekend onbekend |
| Type contract | Vast |
| Branche | Farmacie |
| Locatie | Leiden, Zuid-Holland,Nederland |
| Soliciteer direct | https://www.halix.nl/viral-vector-manufacturing/ |
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