GMP Protein Production
Pre-clinical manufacturing | Clinical and commercial manufacturing | Analytical and Regulatory services
The use of recombinant DNA methods to produce large quantities of protein for therapeutic uses has revolutionized medicine. The number of molecules and their applications have significantly expanded over the last 15–20 years, and with this the need for a reliable manufacturing partner.
When it comes to recombinant protein manufacturing and antibody production, you need a CDMO with the expertise and infrastructure to scale protein and antibody manufacturing, produce high yields, and provide you with your product within budget and on time. Explore HALIX’s track record and GMP protein manufacturing capabilities below.
How we can support your recombinant protein manufacturing
We can support you needs with the development and GMP manufacture of monoclonal antibodies, antibody variants and novel antibody formats, such as bispecific and multispecific antibodies, and therapeutic proteins for human therapeutic use. Our manufacturing is based on mammalian expression systems and we have experience with both adherent and suspension lines. Our technology platform and in-depth know how ensures smooth scale up from lab to commercial scale, while our transparent and agile project management ensures minimum risks.
Preclinical protein and antibody manufacturing
Our pre-clinical recombinant protein and antibody 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.
Batches
- Tech batches: upscaled recombinant protein and antibody production for evaluation of technological capabilities.
- TOX batches: upscaled protein and antibody production to deliver material for use in toxicological studies.
Testing
- Testing and characterization: safety testing, bio-assays, bio-chemical assays, potency testing, stability testing.
Regulatory
- Regulatory support: dossier development pre-IND, IMPD.
Clinical protein and antibody manufacturing
We perform the cGMP manufacture of recombinant protein and antibody drug substance and drug product for all phases of clinical trials (phase 1 – 3), meeting regulatory compliance globally.
Cell banks
- Production, safety testing and characterization of research, master and working cell banks (MCB/WCB).
Bulk protein drug substance
- Cell culturing (USP): clinical drug substance recombinant protein manufacturing based on mammalian cell culturing in roller bottles, cell factories, and (fed)batch single-use bioreactors.
- Purification/formulation (DSP): single use chromatography systems, large scale single-use TFF system, and controlled filtration.
Drug product
- Aseptic fill and finish of protein and antibody products, freeze-drying of drug products, as well as labeling and secondary packaging of biopharmaceutical products with custom layouts and randomization.
Commercial protein and antibody 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 banks
- Production, safety testing and characterization of research, master and working cell banks (MCB/WCB)
Bulk protein drug substance
- Cell culturing (USP): commercial drug substance protein manufacturing based on mammalian cell culturing in roller bottles, cell factories, T-flasks, (fed)batch and perfusion single-use bioreactors.
- Purification/formulation (DSP): single-use chromatography systems, large scale single-use TFF system, and controlled filtration.
Drug product
- Aseptic fill and finish of recombinant protein and antibody products, freeze-drying of drug products, as well as labeling and secondary packaging of biopharmaceutical products with custom layouts and randomization.
Analytical
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 manufacturing
-
Preclinical protein and antibody manufacturing
Our pre-clinical recombinant protein and antibody 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.
Batches
- Tech batches: upscaled recombinant protein and antibody production for evaluation of technological capabilities.
- TOX batches: upscaled protein and antibody production to deliver material for use in toxicological studies.
Testing
- Testing and characterization: safety testing, bio-assays, bio-chemical assays, potency testing, stability testing.
Regulatory
- Regulatory support: dossier development pre-IND, IMPD.
- Clinical (Phase I-III) manufacturing
-
Clinical protein and antibody manufacturing
We perform the cGMP manufacture of recombinant protein and antibody drug substance and drug product for all phases of clinical trials (phase 1 – 3), meeting regulatory compliance globally.
Cell banks
- Production, safety testing and characterization of research, master and working cell banks (MCB/WCB).
Bulk protein drug substance
- Cell culturing (USP): clinical drug substance recombinant protein manufacturing based on mammalian cell culturing in roller bottles, cell factories, and (fed)batch single-use bioreactors.
- Purification/formulation (DSP): single use chromatography systems, large scale single-use TFF system, and controlled filtration.
Drug product
- Aseptic fill and finish of protein and antibody products, freeze-drying of drug products, as well as labeling and secondary packaging of biopharmaceutical products with custom layouts and randomization.
- Commercial manufacturing
-
Commercial protein and antibody 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 banks
- Production, safety testing and characterization of research, master and working cell banks (MCB/WCB)
Bulk protein drug substance
- Cell culturing (USP): commercial drug substance protein manufacturing based on mammalian cell culturing in roller bottles, cell factories, T-flasks, (fed)batch and perfusion single-use bioreactors.
- Purification/formulation (DSP): single-use chromatography systems, large scale single-use TFF system, and controlled filtration.
Drug product
- Aseptic fill and finish of recombinant protein and antibody products, freeze-drying of drug products, as well as labeling and secondary packaging of biopharmaceutical products with custom layouts and randomization.
- Analytical
-
Analytical
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.
GMP protein 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:
- Strong experience in adherent and suspension cell lines
- Upstream processing, from small scale up to 1,000 L scale
- Purification using depth filtration, tangential flow filtration (TFF) and chromatography systems
- Single use disposable equipment
- Development using Quality by Design (QbD) principles
- Analytical method development and optimization
- Analytical method qualification and QC method validation
- Early stage process development and Design of Experiment (DoE)
- Process optimization and process scale-up
- scale down models and viral clearance studies
- Early and late stage process
- Engineering toxicology batches and GLP TOX study batches
- GMP manufacturing of clinical and commercial Drug Substance and Drug Product, including cell banks
- QC release testing
- Process Performance Qualification (PPQ) and supporting studies
- EU GMP grade C production suites for drug substance manufacturing
- Independent air treatment per clean room
- Unidirectional flow for personnel and materials
- Suitable for decontamination using VHP
- Pharmaceutical documentation system
- Quality management system
- GMP and commercial manufacturing certificate and regular GMP inspections
- Comprehensive quality assurance and Quality Management System (QMS), in compliance with EU GMP, FDA, ICH and other industry standards and guidelines
- Short communication channels by providing direct access to key HALIX project team members
- Project supervision by Sr. management of the customer & scientifically qualified Sr. management from HALIX
- Regular project team meetings ensure progress, alignment, mitigate risks and proactively manage critical activities
- Specialized and interdisciplinary teams fully committed to the project’s success
- One project manager as single use of contact