ATMP CDMO Service

Plasmid DNA

Plasmid DNA is a starting material for advanced therapy medicinal products (ATMP), including RNA therapy, viral vector-based cell therapy, and gene therapy.
Innoforce has a broad spectrum of proprietary technologies in developing and manufacturing plasmid DNA. For any amount (from mg to g), or any application/requirement, Innoforce offers different grades and services to support your programs from pre-clinical through clinical and commercial phases.

End-To-End Plasmid Offerings

Innofoce provides competent capacities and capabilities to satisfy unmet needs in viral vector supply.

01 Pre-clinical phases

•Strain clone selection •Backbone/sequence optimization •GLP-grade plasmid production

02 On-demand development

•Plasmid process development and optimization •Plasmid linearization process development and optimization for mRNA •Analytical assay development

03 Clinical & commercial phases

•E.coli cell banking •GMP-readi ™ grade plasmid production (from mg to g) •GMP grade plasmid production (from mg to g) •Qualified assay for cell bank characterization and plasmid release

Innoforce Plasmid Service
Attributes

GLP grade

GMP-readi™

cGMP

Clone screening	X	X	X
E.coli cell banking (RCB or MCB)	X	X	X
Animal-origin free statement or TSE/BSE statement	X	X	X
Antibiotic free	X	X	X
Shake Flask or High-density Fermentation	X	X	X
Chromatographic Purification	X	X	X
Filling in Class C+BSC		X
Filling in Class C+Isolator			X
Single-use System Process			X
Certificate of Analysis	X	X	X
Manufacturing Summary Report		X	X
Project Master Batch Record			X
GMP Raw Material		X	X
GMP Qualified Facility & Utility		X	X
QA Oversight and Release		X
Full QA Oversight and Release			X
Standard QAA		X
Customized QAA			X
cGMP Compliant Statement		X	X
Tech Transfer Supporting			X
On-site Audit			X
Customized Documents and Availability			X

Analytical
Capabilities

Innoforce has established robust and reproducible analytical methods based on the current regulatory environment and clients’ needs. We can perform more than 120 analytical assays and provide clients with multiple method options to balance efficiency, compliance, and costs.

Attribute

Method

Appearance	Visual inspection
pH	pH
Sequencing	Sanger
Sterility	Compendial Method
Host Cell Protein	ELISA
Host Cell DNA	qPCR or ddPCR
Host Cell RNA	AGE
Entodoxin	Compendial Method
Purity	A260/A280
Concentration	UV 260
Restricted Enzyme Digestion	AGE
Supercoiled Content	HPLC/CGE
Mycoplasma (opt.)	qPCR
Kana-Residue (opt.)	ELISA

Applications

RNA template

We have extensive experience producing linearized plasmids with proprietary upstream fermentation and unique purification processes. We have produced plasmids with different lengths of Poly A tails for various applications, including mRNA, circular RNA, and self-amplifying RNA.

Raw material for viral vectors

Our team has accumulated experience producing over 100 batches of plasmid DNA with different constructs. We offer off-the-shelf helper plasmids for lentiviral vector production to accelerate clinical programs. We have also developed proprietary backbones for Gene of Interest (GOI) plasmids.

DNA vaccine

DNA vaccine involves the direct introduction into appropriate tissues of a plasmid containing the DNA sequence encoding the target antigen(s). Innoforce understands the appropriate methods to produce and control plasmid DNA vaccines and guarantees fully-compliant and high-quality product delivery.

Project Delivery Strategy

Our PD and GMP manufacturing team collaborate closely and work efficiently to provide an optimal strategy for your program.

We start with the transfer of your molecule and evaluate the fitness with platform process.

If the platform process works, we simplify the process by applying a plug-and-play model, directly transferring the data to the GMP manufacturing team to allow the production of quality products.

If the platform process does not fit the molecule, we transfer it to our PD team for troubleshooting to develop an optimal process.

Technical transfer from the PD team to the GMP manufacturing team for the production of quality products.

Resource

Download - Innoforce RNA CDMO Services

Download - Innoforce Plasmid CDMO Services