iBio CMO

Rapid, Flexible and Scalable Bio-manufacturing Solutions

A Leader in the Plant-Made Pharmaceuticals Production Platform

iBio CMO has broad capabilities in plant, cell culture and microbial-based expression systems.
With these capabilities, iBio CMO maintains the full range of options for biological product
development and manufacturing to respond to current unmet patient and global needs.

Platform Advantages

Manufacturing in whole green plants offers a number of advantages over traditional systems for the development and
production of protein therapeutics such as monoclonal antibodies.

01

Flexibility and speed

The flexibility and speed of plant technology enables high throughput screening and optimization of biotherapeutics before they ever reach clinical trials.

02

Opening new treatment paradigms

Plants are able to make novel and complex proteins that may be difficult to make in conventional cell-based systems, thus providing the opportunity to open new treatment paradigms for patients with unmet medical needs.

03

Lower facility and production costs

There are significantly lower facility and production costs associated with plant-based technology.

04

Scale to meet increased and varied demand

Plant systems can easily be scaled to meet increased and varied demand, from personalized medicine to rapid response to a global need.

05

Speed of production

The speed of production allows accelerated screening of new therapeutics and vaccines against emerging threats including pandemic events.

06

Less risk of pathogens

Plant-based protein manufacturing technology uses no animal products or animal cell substrates, eliminating the risk of human pathogen contamination.

Facility Design:
Facility Design:

Built for Speed, Flexibility and Scalability

iBio CMO’s 124,000 square foot facility is dedicated to cGMP manufacturing:

  • Capacity of up to 4.4 million plants
  • Fully contained and highly automated
  • Supported with redundant equipment and 2 megawatts of automatic emergency backup power
  • Direct scale-down R&D pilot facility
  • Downstream processes all housed in autonomous cleanrooms

Flexible Bioprocessing Facilities

iBio CMO's production facilities leverage the advantage of using plants as bioreactors. The plants are generic bioreactors for upstream production and are transformed using a "transient" expression system that will produce proteins in 7-10 days post-transfection. Scale-up is not an issue since all the plant "bioreactors" are identical. Expression of new proteins is rapid since traditional cell line development is not necessary.

Downstream processes are housed in autonomous modular clean-rooms. These facilities can be rapidly adapted to new processes.

The iBio CMO facility is capable of making multiple products simultaneously or sequentially to respond to changing demand. This flexibility and scalability is critical when producing biotherapeutics and vaccines to respond to emerging natural or man-made threats.

A Broad Range of Capabilities

iBio CMO provides integrated R&D services and manufacturing platforms that include process development and advanced analytical services. The manufacturing platform produces products faster and at a more affordable cost. iBio CMO’s extensive expertise and commitment to quality gives room for a strong manufacturing plan for your clinical studies.

Tested and Approved

  • Plants are well-suited to express complex proteins such as monoclonal antibodies
  • Plants do not support the growth of human or animal pathogens, thus minimizing risk and cost
  • As of today, the FDA and EMA have approved a plant-made biologic and >12 plant-made products have entered the clinic
  • iBio CMO has produced more than 17 monoclonal antibodies, more than 3 subunit vaccines and more than 4 recombinant proteins

Rapid development

  • Accelerated development with one partner, one facility
    • Gram to kilogram quantities of cGMP product within 4-5 months
  • Scale-down R&D pilot facility with autonomous cleanrooms
    • Direct and simple scale-up from pilot to manufacturing
  • Optimized expression vectors and genes using iBio Technology and Novici GRAMMRTM system
  • BSL2 lab dedicated to In Vitro assay testing and development
  • In-house Quality Control and Quality Assurance Teams

Flexible manufacturing

  • Increased flexibility through single use systems and self-contained and self-sufficient cleanrooms (PODs)
  • Six PODs currently dedicated for:
    • Tangential Flow Filtration (TFF)
    • Chromatography
    • Sterile Fill/Finish
    • Buffer preparation and storage
    • Equipment sterilization
    • Biosafety Level 2 (BSL2) laboratory

Vertical Pharming

iBio CMO’s Vertical Pharming™ Manufacturing is a three-step process:

01

Plant Production

Multi-level growing environment under proprietary LED lighting

02

Plant Infiltration

Expression vectors delivered by vacuum agroinfiltration

03

Downstream Purification

Multiple autonomous cleanrooms to accommodate downstream process activities

Process Flow Timeline



Small scale pilot study

4-5 Weeks

(Milligram to Gram quantities)

Intermediate scale engineering study

6-8 Weeks

(Gram to Kilogram quantities)

Optimization to enhance product yield and/or quality

Can be performed in parallel

Large Scale Manufacturing

 

(Kilogram quantities)

Facility Excellence Award

Facility Excellence Award

In 2013, the iBio CMO facility received the Facility Excellence Award from Pharmaceutical Processing at the Interphex Conference in New York City for its unique facility. The facility leverages a plant-made pharmaceutical platform and highly flexible and scalable downstream capabilities.

iBio CMO: One of the world's largest
plant-based manufacturing facilities.