Sign in | Register

Flyer

One-Stop mRNA Vaccine Solution for IND Filing - in as Little as 5 Months

5-Month One-stop Solution for IND Filing

Plasmid

Linearized DNA

IVT-mRNA

mRNA-LNP

mRNA Vaccine Manufacturing Process

1

2

3

4

1

2

3

4

Proprietary PowerS™-

T7 RNA Polymerase, VCE, 2´-O-Methyltransferase

PolyAssure Strain

Proprietary IntegraBone

T7 RNA Polymerase

Nanoparticle component:

Nanoparticle component

Cholesterol, phospholipids,

Cholesterol, phospholipids,

PEG derivatives, cationic lipids

PEG derivatives, cationic lipids

Uncapped

Uncapped

mRNA

Capped

Capped

mRNA

mRNA

Chromatographic

Chromatography

Puriﬁcation

mRNA

Enzymatic capping

Enzymatic capping

UF/DF

UF/DF

Microfluidic mixing

mRNA & buffer

mRNA

Process 1.0

or

T7 RNA Polymerase,

T7 RNA Polymerase

Capped

mRNA

cap analog

cap analog

ProPlus^TMProcess

Co-transcriptional capping

co-transcriptional capping

1.0 Process

Plasmid

Linearized DNA

TM

IVT-mRNA

mRNA-LNP

ProPlus Process

Plasmid

Linearized DNA

IVT-mRNA

mRNA-LNP

Linearized DNA (Plasmid as in Process Control)

mRNA Platform

mRNA Plasmid Platform

mRNA Plasmid Platform

mRNA&LNP Platform

IVT-mRNA: enzymatic and co-tran

scriptional capping

-

Platform for plasmid with Poly A

IVT-mRNA: enzymatic and

Proprietary PowerS™-PolyAssure

co-transcriptional capping

strain and IntegraBone ensure

Leading linearized DNA platform

6-Month

for IND Filing

One-stop Solution

for IND Filing

poly(A) integrity

LNP encapsulation:

50+ ongoing projects

Process 1.0 and ProPlus^TMprocess:

One-stop Solution

5-Month

encapsulation, encapsulation

microfluidic technology

10+ IND approved globally

provide best solution for clients

mRNA QC: comprehensive, in-house,

700+ clinical batches

(US, China, Japan, Korea, etc.)

mRNA QC: comprehensive, in-house,

compliant with the requirement in US,

compliant with the requirement for

30+ IND clearances

st

1

BLA & commercial project

in China

global ﬁlings

(US, China, Japan, Korea, etc.)

1^stBLA & commercial project in China

^E4^{U a}m^ndR^CN^NA IND Clearances (US & China)

ProBio Service Overview – from Plasmid to mRNA

Phase

I

Phase

II

Phase

III

IND

BLA

BLA

IND

Pre-Clinical

Commercial

GMP Grade

Plasmid &

Plasmid &

Pro Grade

PreCMC Grade

IND CMC

IND CMC

GMP-Principle* Grade

GMP Grade

BLA PC/PV

BLA PC/PV

Linearized DNA-

Linearized DNA

IVT-mRNA

Pro Grade

Pro Grade

Clinical GMP Grade

GMP Grade

GMP Grade

GMP Grade

mRNA -

GMP Grade

GMP Grade

mRNA-LNP

*2 choices in GMP-Principle grade: IND Pro for FDA & EMA; GMPro^TMfor NMPA(China), FDA & EMA

ProBioCDMO.com

+1-732-885-9188

cdmo.us@probiocdmo.com

Accelerating Ideas. Delivering Impact.

Plasmid ProPlus^TMProcess

ProPlus^TMprocess has

Less plasmid puriﬁcation steps (in process

control instead of full QC release)

Optimized linearized DNA puriﬁcation

Advantage

Improve recovery rate, reduce product loss

Shorter turnaround time: as fast as 2 weeks

ProPlus™ process for low copy plasmid;

Process 1.0 for high copy plasmid

Process 1.0

ProPlus Process

Recovery Rate

Yield

10.00

8.00

12

9

6.00

IVT-mRNA Platform

10

8

100%

80%

60%

40%

20%

0%

6

4.00

3

2.00

Suitable for mRNA with different lengths

0.00

6

1K-10K

0

GOI 1 GOI 2 GOI 3 GOI 4 GOI 5

0.2

0.4

1

1.3

25

Two capping methods (co-transcriptional

Scale (mL)

4

2

0

and enzymatic capping methods): capping

efﬁciency >90%, up to 99%

1.2K

Excellent nanoparticle characterization: size (70 - 85 nm), PDI (0.02 - 0.1)

2K

3.5K

82-99.7%

100.00%

0.12

0.1

80.00%

mRNA-LNP Platform

100%

80%

60%

40%

0.08

0.06

0.04

0.02

0

40.00%

40.00%

Universal LNP platform with

20.00%

excellent critical quality attributes

0.00%

Encapsulation efﬁciency up to 99.7%

LNP1 LNP2 LNP3 LNP4 LNP5 LNP6

(0315) (102) (MC3) (AX4) (M) (0315)

LNP5 LNP6

(M) (0315)

LNP6

LNP1 LNP2 LNP3 LNP4 LNP5

(0315)

(0315) (102) (MC3) (AX4) (M)

20%

0%