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Viral Vaccines

Vaccination classically involves the use of attenuated live virus or inactivated virus. The aim is to enhance immune response which will bring protection against infection and resulting disease.
Measle vaccine or Influenza (Flu) vaccine are good examples of immunization.

Manufacturing of the so-called viral vaccines is a well-established approach in the biopharma industry.
Depending on the targeted viral strains, production steps will require the use of eggs or a large range of cell lines to ensure high yields and quality of material.

Through a long history with the human and animal health vaccine industry, Clean Cells has built a strong portfolio of vaccine dedicated services supported by our GMP licence and extensive regulatory knowledge. The company offers a wide range of services for viral vaccine manufacturer, including cell bank production and storage, characterization and testing all along manufacturing of vaccine candidates.

Cell and virus bank manufacturing

Thanks to more than 20 years in the field of vaccine manufacturing, Clean Cells has experience working with mammalian, insect, avian cell lines and related viruses used in the development of diverse vaccine products such as Influenza vaccines.

Clean Cells provides cell bank and virus bank manufacturing services and associated quality control either in R&D or GMP grade to ensure and efficient development process of vaccines for human or animal health.

Cloning selection

According to authorities’ expectations, Clean Cells has implemented a state-of-the platform for cloning. This service allows the selection of the most potent clone and ensures a suitable stability of the production yields.

Biologics testing

Clean Cells is an established expert in biosafety testing with a proven cGMP track record as part of its vaccine related services. Clean Cells’ team has developed and validated numerous assays that are applicable to a broad range of human and animal health vaccines.

Recommendations for the testing of Viral vaccines are provided by competent authorities, including EMEA, FDA and the EDQM (European Pharmacopoeia) and include: detection of bacteria, yeast, fungi, mycoplasma, virus and retrovirus detections.

Human Vaccines

	MCB	WCB	EOPC	Virus Seed	Unp BH	DS	DP
Sterility	•	•			•	•	•
Mycoplasma detection	•	•			•
Mycobacterium detection	•	•			•
Identity (qPCR, DNA fingerprinting, Karyotyping, Barcoding)	•	•	•
Transgene identity / Integrity by sequencing (qPCR, Sequencing)	(•)	(•)	(•)		•
Adventitious agent detection (in vitro testing)	•	•	•	•	•
Retrovirus detection By direct Q-PERT Semi-quantification by TEM	• •	• •	•	(•)
Adventitious agent detection (in vivo testing)	•		•
Tumorigenicity (Cell type dependent)	(•)		(•)
Specific virus detection by PCR (Cell type dependent)	•	•	•
Bovine & porcine viruses detection (depending on raw materials and culture process)	(•)	(•)	(•)
Lentivirus & AAV specific testing Physical particles titer Vector genome titer Replication-competent virus detection (RCL, rcAAV) Infectious particles titer				•	•	•	(•)
Endotoxins detection						•	•
Impurities (host-cell DNA & proteins, BSA, Benzonase, residual sequences…)					•	•	(•)
Physicochemical tests (pH, osmolality, visual aspect)						•	•

Custom analytical development

According to regulatory evolutions and requirements, or specificity of the developed vaccines themselves bespoke services, including analytical development solutions (qPCR, ELISA, TCID50, dPCR, cell based assay, FACS,…), may be required.

Clean Cells offers support including creating methods, improving existing ones, evaluating suitability, providing advice and guidance, testing starting materials. Support for the qualification and validation of analytical methods can include transferring methods in-house, initial qualification, or complete validating them in accordance with cGMP expectations and worldwild regulations (ICHQ2).

Cell and virus bank storage

Cell and virus banks are valuable items in the process of producing vaccines.

Our services include cell bank storage and virus bank storage solutions for the preservation of R&D and GMP material, ensuring safety and stability for long term period.

Dedicated and secure areas are combined with 24/7 surveillance of storage spaces and complete back-up systems and power supply.

	+5°C	-80°C or -25°C	<-145°C
Shared storage	•	•	•
Dedicated storage	N/A	N/A	•
Periodic storage report	•	•	•
Continuous temperature monitoring	•	•	•
Automatic or manual measurement of LN2 levels	N/A	N/A	•
Externalized alarm system with on-call workers	•	•	•
Semi-automatic or manual LN2 filling	N/A	N/A	•
Backup equipment	•	•	•
Backup supply power	•	•	N/A

Leaflet

Human Viral Vaccine Leaflet

Download via media library

Please reach out for the full detail of vaccine related services applicable to your product.

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