pharmaceuticals
biopharmaceuticals
bio-industries
agrochemicals
functional ingredients
food ingredients
fine chemicals
032-
026
Broc
hure
Vira
l Vec
tors
Nov
embe
r 201
9 / G
raph
ical d
esig
n: A
vanc
e / D
esig
n &
layou
t: Em
man
uelle
Bail
ly
Viral Vectors:finding the good in everyone
A global and integrated offer from vector developmentto final product release:
> Process transfer, development, optimization, scale-up and validation> Assays transfer, development and validation> Small to large scale manufacturing> Upstream, downstream and aseptic Fill & Finish> Pre-clinical, clinical and commercial applications> Wide range of Viral Vectors manufactured (AAV, Lentivirus, Adenovirus, HSV, VSV...)
Viral Vectors can contribute to transform lives of patients with severe diseases:Novasep, as a reliable , is committed and proud to be part of this rewarding challenge by offering a support to your clinical & commercial manufacture of Viral Vectors.
A strong track recordA strong track record
FINDING THE GOOD IN EVERYONEFINDING THE GOOD IN EVERYONE
Our specific know-how in a wide range of Viral Vectors includes: AAV, Lentivirus, Adenovirus, HSV, VSV, VEEV... for cell & gene therapy, CAR-T, immunotherapy, vaccination and other therapies.
produced and released by Novasep in the last 5 years.
For 20 years, Novasep has acquired experience in the development and manufacturing of biomolecules.
Senrise-IV, our commercial production facility
Senefill, our new commercial facility for aseptic Fill & Finish
Senrise-IV is dedicated to the production of your Viral Vectors.
To support the launch of your product, Novasep has opened a new commercial facility for aseptic Fill & Finish operations: Senefill.
Our commercial solutionsOur commercial solutions
• 2 independant cGMP manufacturing lines • USP & DSP• Suspension and/or adherent modes• Up to 2,000L scale• Commissioned in Q1 2019• Seneffe, Belgium
Guided tourGuided tour
>150 cGMP
BATCHES
• A full state-of-the-art facility • Fully automatic filling under isolator• Up to 10,000 vials per session• Filling of Viral Vectors, plasmids
and other biologics (mAbs, proteins...) • Stand alone services as well as integrated
drug product manufacturing• Commissioned in H2 2019• Seneffe, Belgium
Guided tourGuided tour
A complete offering including transfer, development, optimization and validation.
Our clinical solutionsOur clinical solutions
Downstream processing (DSP)• Large set of purification technologies: chromatography, TFF, filtration...• Scalable up to 1,000L
Production servicesProduction services
Upstream processing (USP)Adherent mode• Disposable support CS10/HS36 • Fixed-bed bioreactors (e.g.: iCELLis®)• Microcarriers in bioreactors
Suspension mode• Batch, fed-batch & perfusion• Disposable technology• Scalable up to 1,000L
Novasep has a fully dedicated plant for Fill & Finish (F&F) offering flexibility for standard & custom services. Our dedicated team can also provide stand alone services.
• Semi-automatic or automatic filling• Hundreds to 4,000 vials per session• Customizable (volume, stoppers, vials)• 2mL to 100mL vials • Filled volume: 0.25mL to 100mL
F&F servicesF&F services
Our 2 sites in BelgiumOur 2 sites in BelgiumSeneffe: clinical and commercial productionGMP: USP, DSP & F&FQC labs Mid- to Large scale up to 2,000L
Gosselies: clinical productionProcess & Analytical development GMP: USP & DSP Small to Mid- scale up to 200L
EASY ACCESS AND IN THE HEART OF BELGIUM’S LARGEST BIOTECH HUB:
• 5 minutes from Charleroi airport • 1-hour from Brussels or Lille airports• 20 minutes by car between our 2 sites
Following its recent investments with Senrise-IV and Senefill, Novasep has launched a unique 2-year turnkey plant offer to accelerate commercial production of Viral Vectors.
oXYgeneoXYgeneTM A fully integrated offer for Viral Vector production
• Parternship solution• Design, construction and operation of customer dedicated facilities• 2 years • On Novasep sites• Senefill: plant ready to serve oXYgeneTM customers
Key informationKey information
DRUG PRODUCT RELEASED
BY NOVASEP QUALIFIED
PERSON
Enjoy the visit
BELGIUMGERMANY
NETHERLANDS
FRANCE
LUXEMBOURG
GOSSELIESSENEFFE
BRUSSELS
AsiaNovasep Asia+86 21 6045 1600
EuropeNovasep+33 437 282 030
North AmericaNovasep, LLC+1 610 494 0447
Rest of the worldNovasep+33 437 282 030 03
2-02
6 Br
ochu
re V
iral V
ecto
rs N
ovem
ber 2
019
/ Gra
phica
l des
ign:
Ava
nce
/ Des
ign
& lay
out:
Emm
anue
lle B
ailly
© 2019 Groupe Novasep SAS. Groupe Novasep SAS and/or its affiliates (hereafter Groupe Novasep) own or license the copyrights, trademarks, names, logos, and other rights to the information in this brochure. No right or license is granted to any other losses for access or reliance and not from access. Any unauthorized use without the express prior written consent of Groupe Novasep is prohibited. Disclaimers: The information contained in this brochure are provided “as is”, for informational purposes only, without any representation or warranty of accuracy or completeness. In no event will Groupe Novasep be liable to any party for any damages or any other losses from access or reliance upon any information contained in this brochure.
Services and technologies for the life science industries
www.novasep.com
Viral Vectors CapabilitiesViral Vectors CapabilitiesMODE PERFORMANCE SUITES DESIGN
Clinical facility, manufacturing suites
for small to mid-scale production
Suspension using bioreactors ranging from 50L to 200L
Adherence mode in CS10 or HS36
Up to 4 productions in parallel
8 suites Grade C production suites with operations under grade B
Modular area
cGMP multiprocess/ multiproduct facility Clinical facility,
manufacturing suites for mid
to large-scale production
Suspension using bioreactors ranging from 50L to 1,000L
Adherence mode in CS10 or HS36
Up to 2 productions in parallel
3 suites
Senrise-IV, commercial facility
Suspension and/or adherent modes
Up to 2,000L scale (USP and DSP)
2 cGMP manufacturing lines Grade C production suites with operations under grade B
Clinical Fill & Finish facility
Semi-automatic or automatic filling
From hundreds of vials up to 4,000 vials per session
1 suite
Grade B aseptic suite with operations under grade A
(RABS)
Senefill, commercial Fill & Finish facility
Automatic filling under isolator
Up to 10,000 vials per session
1 suite
Grade C aseptic suite with operations under
grade B and grade A (isolator)
Contact our experts: [email protected]
Follow us on
SEN
EFFE
GO
SS
ELIE
S
NOVASEP HAS PRODUCED NUMEROUS CLINICAL GRADE BATCHES OF AAV’S DIFFERENT SEROTYPES, USING BACULOVIRUS/SF9 AND TRANSFECTION TECHNOLOGIES, IN BOTH ADHERENCE AND SUSPENSION MODES.
Parental virus is apathogenic
Long-term expression of the transgene
Episomal vector
Low immunogenicity
Transduce non-dividing & dividing cells
Numerous serotypes with different tropisms
Low DNA packaging capacity (4.5kb)
Empty vector particles generated during the manufacturing process
Pre-existing immunity
Highly resistant vector particles
AAV Vectors:finding the good in everyone
AAV Serotype Production System Process Production scale Project Clinical stage(s)
Recombinant AAV1HeLa
SuspensionSTR
AdV Helper Up to 1 000L SUB PD Phase III
Recombinant AAV2HEK293Adherent
CS10Transient transfection 24CS10
PD & cGMPDS & DP
Phase I, II & III
Recombinant AAV3HEK293
iCELLis® 500Transient transfection iCELLis® 500
PD & cGMPDS & DP
Phase I/II
Recombinant AAV5HEK293Adherent
CS10Transient transfection 24CS10
PD & cGMPDS & DP
Phase I/II
Recombinant AAV8HEK293
SuspensionSTR
Transient transfection 200L SUBPD & cGMP
DS & DPPhase I/II
Recombinant AAVrh10
HEK293Adherent
CS10Transient transfection 24CS10
PD & cGMPDS & DP
Phase III
sf9 Baculovirus infection 200L SUBPD & cGMP
DS & DPPhase I/II
20+ CLINICAL BATCHES PRODUCED... AND STILL COUNTING
Drawbacks
Various genetic eye diseases
Cystic fibrosis
Haemophilia
Cancer
AAV PROFILE
Benefits
Applications CNS
And many others...
Did you know?Did you know?
NOVASEP HAS PERFORMED 5 PROJECTS BASED ON ADV, ESSENTIALLY FOR ONCOLYTIC APPLICATION UP TO THE SCALE OF 50L IN BIOREACTORS.
Benefits Drawbacks Ensure high level of transgene expression
Transduce non-dividing & dividing cells
Larger cloning capacity
Tumor-targeted replication of specifically designed oncolytic adenovectors
Vector particles produced at high titer
Highly immunogenic
The vector genome does not integrate into the host cell genome
Transient transgene expression only
Pre-existing immunity (AdV5)
Risk of inflammatory response
Type Production System Process Application Project Clinical stage(s)
Oncolytic AdV5HeLa
SuspensionPerfused STR
Infection CancerPD, scale-up
& cGMPDS & DP
Phase I/II10L STR
Chimeric Oncolytic AdVHEK293
SuspensionSTR
Infection CancerPD, scale-up
& cGMPDS & DP
Phase I/II50L STR
ADV CLINICAL BATCHES PRODUCED... AND STILL COUNTING
ADENOVIRUS (ADV) PROFILE
Adenovirus Vectors:finding the good in everyone
Cancer therapy (oncolytic AdV)
Vectorized vaccines
Applications
Did you know?Did you know?
NOVASEP HAS PERFORMED MORE THAN 30 PROJECTS ON DIFFERENT TYPES OF OTHER VIRAL VECTORS, INCLUDING HSV, VEEV, EITHER IN SUSPENSION OR IN ADHERENCE MODES.
Type Production System Process Application Project Clinical stage(s)
Recombinant Measles VirusMRC5CF10
Infection VaccinecGMP
DS & DPPhase I/II 24CF10
Oncolytic undisclosed VirusHeLa
SuspensionSTR
Infection CancerPD, scale-up
& cGMPDS & DP
Phase I/II 50L SUB
Recombinant VEEV(Venesuelian Equine Encephalitis Virus)
VEROAdherent
CS10
Transfection by electroporation
VaccinecGMP
DS & DPPhase I/II
CS10
Recombinant VSV(Vesicular Stomatitis Virus)
VERO Adherent
CS10Infection Vaccine
cGMPDS & DP
Phase I/II15CF10
Recombinant VSV(Vesicular Stomatitis Virus)
VERO Perfused STRmicrocarriers
Infection VaccinePD, scale-up
& cGMPDS & DP
Phase I/II50L SUB
PD in progress
Recombinant HSVVERO
AdherentHS36
Infection CancerPD & cGMP
DS & DPPhase I/II15HS36
Attenuated Influenza Virus (A/H1N1, H3N2, H5N1 & B)
VEROAdherent
CF10Infection Vaccine
PD & cGMPDS & DP
Phase I/II 15L / 15CF10
Recombinant DengueVEROSTR
microcarriersInfection Vaccine
PD & scale-up
DS
Pre-clinical50L SUB
Oncolytic H1 virusHuman T-cells
Wave BRInfection Cancer PD, USP
Pre-clinical25L Wave
Baculovirus vectors encoding VLP or recombinant protein
Sf9 or Hi-5Suspension
STRInfection Vaccine
PD, scale-up & cGMPDS & DP
Phase I/II 10L & 50L SUB
Wild type HIV (BSL3)Human T-cells
STRInfection Vaccine
PD, scale-up
Phase I/II 50L SUB
30+ CLINICAL BATCHES PRODUCED... AND STILL COUNTING
Other Viral Vectors:finding the good in everyone
Mainly vectorized vaccines
Oncolytic vectors
Rec. proteins: sub-unit vaccines, mAbs, ADCs, conjugates, cytokines, various therapeutical proteins
Applications
Did you know?Did you know?
NOVASEP HAS PRODUCED MORE THAN 40 BATCHES OF LENTIVECTORS BASED ON HIV-1 AND ON EIAV (EQUINE), IN BOTH ADHERENCE AND SUSPENSION MODES.
Benefits Drawbacks Long-term expression of the transgene
The vector genome integrates into host cell genome
Low immunogenicity
Transduce non-dividing & dividing cells
VSV-G pseudotyped LV have a broad host-cell range and confer a high particle stability
DNA packaging capacity relatively limited (10kb)
Possible insertional mutagenesis
Enveloped particles are poorly resistant, which makes their storage, production and purification difficult
Few pseudotypes available (mainly VSV-G)
Type Production System Process Application Project Clinical stage(s)
Lentiviral vectors based on EIAV
HEK-293TAdherent
CF10Transient transfection Gene Therapy
cGMPDS & DP
Phase I/II 24CF10
Lentiviral vectors based on HIV
HEK-293TAdherent
CF10 & HS36Transient transfection Vaccine
PD, scale-up & cGMPDS & DP
Phase I/II25L / 25CF10
120L / 15HS36
Lentiviral vectorsHEK-293T
SuspensionTransient transfection Gene Therapy
PD, scale-up & cGMPDS & DP
Phase II/III50 and 200L STR
40+ CLINICAL BATCHES PRODUCED... AND STILL COUNTING
LENTIVECTOR PROFILE
Lentivirus Vectors:finding the good in everyone
Correction of inherited genetic defects
Cancer immunotherapy via CAR-T cell therapy
Applications
Did you know?Did you know?
Learn more about
AAV, Lentivirus, Adenovirus and HSV vectors in our dedicated publications including case studies!
Top Related