Xpress Biologics - General presentation

1. Proteins & DNA for pre-clinical applications
General presentation

2. Mission of Xpress Biologics & value chain
The mission of Xpress Biologics is to enable the transition of projects from R&D to clinical manufacturing.
Clinical
validation
Number
of
Biologics
Discovery of
new
candidates
Pre-clinical
validation Manufacturing
Time
Universities
Biotechs
Pharmas
…
CMOs, Pharmas
CMOs, CROs, Pharmas…
• Small amounts (µg – mg)
• Medium purity (80-90%)
• « R&D » grade biologics
• Native and tagged molecules
• Medium/large amounts (10 mg – 100 g)
• High purity (>95%)
• « R&D » & « GLP » grade biologics
• Native molecules
• Large amounts (tens to hundreds of g )
• High purity (>95%)
• «GMP » grade biologics
• Native molecules
• Very/Large amounts (tens to hundreds of g )
• High purity (>95%)
• «GMP » grade biologics
• Native molecules
≈ 7.000
> 10 years

3. Mission of Xpress Biologics & value chain
The mission of Xpress Biologics is to enable the transition of projects from R&D to clinical manufacturing.
Clinical
validation
Number
of
Biologics
Discovery of
new
candidates
Pre-clinical
validation Manufacturing
Time
Universities
Biotechs
Pharmas
…
CMOs, Pharmas
CMOs, CROs, Pharmas…
Services proposed
 Development of Research Cell Banks
 Process & QC development
 Scaling-up study
 « R&D », « engineering » & « GLP » manufacturing
 Transfer to CMO & « GMP » manufacturing
 Management of pre-clinical & clinical trials
Markets targeted
 Human healthcare (pre-clinical market)
 Animal healthcare
 IVD market
 Medical imaging
 …

4. Process development services
Molecular Biology
 Design of microbial expression systems:
• More than 25 E.coli (soluble, IB, periplasmic) expression systems (≠ SP, ORI, RBS, promoter...)
• More than 30 P. pastoris (secreted) expression systems (≠ strains and SP)
 IP free expression vectors
 P. pastoris: evaluation of different SP and clone screening
USP development
 Development of high cell density fed-batch fermentation
 Optimization of the harvest & extraction conditions
 Preparation, solubilization & refolding of inclusion bodies
DSP development
 HTP batch chromatography (resin and binding/elution screening)
 Dynamic small-scale column fine-tuning
 Ultrafiltration and microfiltration optimization
Analytical tools
 In process controls
 Quality controls (physical state, identity, content, purity/impurity, safety and potency assays)

5. Manufacturing activity
« R&D » manufacturing
 Use of Xpress Biologic standard fermentation processes
 Basic purification process with purities ≥ 80% (tagged and untagged proteins)
 Production scale between 100 mg and 1 g
 Basic QC
 Delivery of CoA
 For in vitro applications and initial activity assays
« Engineering » manufacturing
 Upstream Process Development (high cell density fedbatch fermentation)
 Downstream Process Development with 95% purity (untagged protein)
 Production scale between 1 g and 50 g
 QC development
 Formulation development
 Delivery of a Process development report
 For in vitro applications & initial in vivo testing
 « Ready-To-Transfer » process for « GMP » production
« GLP » manufacturing
 Use of the « engineering » process
 Delivery of the « GLP » documentation and report
 For « GLP » in vivo applications
Upstream
Downstream
Quality control

6. Manufacturing expertise
 From 100 mg up to 20 g of purified
plasmid
 >20 different plasmids produced
Plasmid DNA Antibody fragments
 From 100 mg up to 50 g of purified
product
 >25 AB fragments produced
Recombinant proteins
 From 100 mg up to 50 g of purified
proteins
 > 25 different proteins produced
 Microbial expression systems: E. coli (soluble, IBs, periplasmic) & P. pastoris (secreted)
 Off-the-shelf and optimized production processes
 « R&D » & « GLP » grade material
 IP free expression systems
 GMP compliant production processes (regulatory and scaling-up)

7. Needs and solutions
Good Laboratory
Practices
Adapted
quality
Consultancy &
network
Regulatory
compliance
Knowledge and
expertise
Industrial
compliance
Off license services
Competitive
price
On-the-shelf
production processes
Fast
production
Management &
manufacturing
One stop
shop
Xpress Biologics
Accessia Pharma site
Avenue du Parc Industriel 89
4041 Milmort
Belgium
Phone : +32 (0)4 346 00 20
info@xpress-biologics.com
www.xpress-biologics.com