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Commercial-Scale Biotherapeutics Manufacturing Facility for Plant-Made Pharmaceuticals

Introduction In recent years, the plant‐made pharmaceutical (PMP) community has made significant progress in bringing therapeutics to the clinic: Elelyso™ (Pastores et al., 2014; Zimran et al., 2015) (Protalix, Carmiel, Israel) has been given market registration; non‐Hodgkin's lymphoma vaccines (Bendandi et al., 2010; McCormick et al., 2008; Tusé et al., 2015) (Large Scale Biology, Icon Genetics/Bayer, Halle, Germany), interferon‐α2b (De Leede et al., 2008), CaroRx (Weintraub et al., 2005) and RhinoRx (Planet Biotechnology, Hayward, CA), lactoferrin (Laffan et al., 2011) (Ventria, Fort Collins, CO), anti‐HIV antibody (Rosenberg et al., 2013) (Pharma‐Planta Consortium, EU‐South Africa), edible vaccines (Tacket et al., 2000; Thanavala et al., 2005; Yusibov et al., 2002) (Arizona State University, Tempe, AZ; Thomas Jefferson University, Philadelphia, PA), the influenza serotype H1N1 and H5N1 vaccines (Cummings et al., 2014; Landry et al., 2010, 2014) (Fraunhofer CMB, Newark, DE, and Medicago, Quebec, QC, Canada) and more recently the ZMapp™ cocktail (Qiu et al., 2014) (Mapp Biotherapeutics, San Diego, CA) have demonstrated the potency of plant‐made therapeutics in clinical trials. The development of such plant‐made pharmaceuticals was accompanied over the years with the design and construction of manufacturing facilities of different capacities to accommodate the production of clinical material under current Good Manufacturing Practice (cGMP) standards (Wirz et al., 2012). The first cGMP manufacturing facility producing PMPs was designed by Large Scale Biology Corporation (LSBC) in Owensboro, KY, USA (now Kentucky BioProcessing) and opened in the year 1999 using the plant‐virus transient expression system Geneware® (Pogue et al., 2002, 2010). Later, new plant viral‐based vectors were modified to address different expression strategies and better controlled processes making use of Agrobacterium tumefaciens and a vacuum infiltration procedure (Gleba et al., 2005; Huang et al., 2010; Marillonnet et al., 2005; Roy et al., 2010; Sainsbury et al., 2009). The CSS Cleaner is a brilliant free online tool to take care of your dirty markup.

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iBio Inks 3D Bioprinting Agreement

iBio, Inc. (NYSE AMERICAN:IBIO) today announced that it has entered into a Master Services Agreement (“MSA”) with Lung Biotechnology PBC, a subsidiary of United Therapeutics Corporation (NASDAQ:UTHR), to produce recombinant human collagen (“rhCollagen”)-based bioink for 3D bioprinted organ transplants. iBio will collaborate with Lung Biotechnology PBC to scale-up production of rhCollagen in tobacco plants using iBio’s FastPharming™ System.

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Technology

Why FastPharming ?


FastPharming overcomes issues presented by mammalian expression systems:

  • Speed: Avoids lengthy clone selection and MCB establishment processes by "transfecting at scale"
  • Scale-up: Simple & easy - just plant more plants
  • Sustainability:  Truly "green" manufacturing - no plastic waste when a plant is the "single-use bioreactor"
  • Safety:  Reduced risk of viral contamination
  • Quality:  Accessible, flexible glycosylation controls
  • Cost:  Lower facility CapEx and OpEx in many cases
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Increased Speed-to-Market


iBio CDMO Services


Process Development

FastPharming optimizes gene-expression, glycosylation, and purification parameters to deliver a robust process for your APIs.

cGMP Manufacturing

The FastPharming system transfects at large-scale to easily and reliably deliver biologics in clinical trial or commercial quantities.

Aseptic Fill/Finish

In-line labelling allows serialization of vials and bottles for greater quality assurance of mAbs, viral vectors, and other biologics.

Bioanalytics

An experienced analytical staff provides method development and validation support with expertise in protein characterization using mass spectrometry.

Quality & Regulatory

Quality systems have been carefully constructed to meet cGMP requirements, and iBio can provide regulatory guidance given the team’s experience with therapeutic development.

Factory Solutions

When the time is right, iBio facilitates insourcing by designing and building your own environmentally sustainable FastPharming facilities.

Technology Applications


The FastPharming platform produces a variety of recombinant products including:

  • Biobetter and biosimilar antibodies
  • Antigens for subunit vaccine design
  • Virus-like particles (VLP)
  • Lysosomal enzymes
  • Blood factors and cytokines
  • Scaffolds, maturogens and materials for 3D Bioprinting and biofabrication

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Interested in applying the power of FastPharming to your project?


iBio offers the CDMO capabilities needed to develop and deliver biologics to market - process development, scale-up, cGMP manufacturing, bioanalytical product characterization, aseptic fill/finish, and quality and regulatory support.

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