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Cornerstone® Biomanufacturing Development Services are result of 25 years of hands-on experience with the most challenging biopharmaceutical products and offer a comprehensive approach of integrated process development solutions and novel technology designed to improve the robustness and yield of AAV, pDNA, mRNA, exosomes and other Advanced therapy medicinal products (ATMPs) production, while improving the safety of therapeutic products.
- Are you seeking speed and scalability for your virus particle and large molecule process, from preclinical and PI to PIII and beyond?
- Do you lack expertise and capabilities when it comes to AAV, pDNA or mRNA purification and analysis?
- Are you looking to improve or fix an existing large biomolecule process?
No matter if you are a large company or a start-up. We have got your back!
Downstream part of the process is a complex matrix full of interdependent parameters where optimization is not straightforward, so experience provides the quickest way to identify the key quality attributes for your unique product and optimizing them for best performance. This allows for significant time, labor and opportunity cost savings, permitting your team to focus on bringing your product to clinic and market.
Reach out to us and have your Process Developed in 4 simple steps.
In our expanded, fully-equipped BSL 1 and 2 facilities, we can support you with process development, analytical method development, or preparation of custom purification media with your ligand of choice.
- Contact us Explain your needs, fill out the questionnaire. Let’s identify together your goals and set up a work plan.
- Technical Offer Based on your needs and scope, we prepare an informative offer and all the documentation needed.
- Execution After confirming the plan and signing the contract, just send us your sample and material and we will get busy.
- Tech Transfer Time is of essence so we will do our best to develop the process for you, including SOPs, training, transfer, scale-up , on site support in timely manner.
Innovative Solutions Tailored to Your Needs and Modality
Plasmid
USP
Manufacture of plasmids (E.coli)
Plasmid range: 1 – 30kbp
Bioreactor scale: 10L & 50L
DSP
Purification of plasmid
RNase-free process
mRNA
Plasmid
Linearization optimization, scale-up, IPC analytics
IVT
IVT optimization
IPC analytics, scale-up
DSP
Two-step purification mRNA
Scale-up, IPC analytics
Purity within regulatory spec
AAV | Ad and other viruses
USP
AAV Transfection of plasmids/Adeno upstream (HEK)
Bioreactor scale: up to 10L
DSP
Purification of viruses (AAV, Adeno, vaccina, influenza, etc.)
Scale-up
Dedicated analytical methods
EV
DSP
Purification EV
MALS detection
Dedicated exosome analytics
Phages
Phage expression
Bioreactor scale: up to 50L
DSP
Purification of phages
>8log endotoxin removal
Service & Analytics
Service Offerings:
BSL 1 and 2 labs (non-GMP)
Single step or full process
Reports: SOP | results
Product quality & quantity
Monitoring purification process
Process fingerprints & impurity profiles
Characterization of raw materials
Method validation
Technology comparisons
Custom-made monolith columns
Methods Used:
PATfix LC analytics
UV | FLD | MALS
CGE | AGE | SDS-PAGE
NTA | UAC | UV | MALS
Dot-blot | μBCA
ELISA | qPCR | ddPCR | TCID
HPLC Analytics:
Relative titre and concentration
Purity, yield, MW, radius
Contaminant profile (i.e. HCP | gDNA, etc.)
Full | empty particles (AAV | Ad | VLP)
Quantitative OC | SC (plasmid)
Quantitative: mRNA, IVT components
Integrity of mRNA
Package Options
Feasibility Study:
Single step or full process
Proof of concept (no optimization)
Short report
Timeline: 1 – 2 months
Process Development:
USP, DSP or both
Single step or full process
Full report: results | SOP| tech transfer
Tech transfer support (CDMO)
Timeline: 4 – 12 months
Timelines
