COVID-19

The global coronavirus outbreak has completely turned our lives and everything that we know, upside down. COVID-19 crisis is dramatically displaying the need to expedite vaccine development in order to mitigate national, regional and global uncertainties and fear.

The need for effective vaccine in shortest possible timeframe is leading to the rise of different novel vaccine strategies like Nucleic Acids, Viral Vectors, VLPs, among others. Hand in hand, this situation and its dimension call for the most innovative, flexible and productive bioprocessing stragtegies and  tools available. Taking a look at the novel vaccine candidates, one feature stands out – namely the size of the biomolecule – we are talking of extremely large, complex biomolecules – and this feature makes them ideal candidates to be processed with Monoliths.

On May 14th, as part of the Corona360 In Conversation series -  Asia’s SARS-CoV-2 Vaccine Development Challenges BIA Separations attended this event as a Gold Sponsor. Ingo S. Nagler, our BDO, presented CIMmultus™ Monoliths – tailored to accelerate process development and address large scale manufacturing of ATMPs and Vaccines.

In the presentation he provided an overview of emerging COVID-19 vaccine strategies (pDNA, mRNA, VLP, AAV) in the context of purification challenges and potential solutions and discussed the importance of selecting proper down-stream bioprocessing tools, in order to provide capacity, resolution and productivity.

Plasmid DNA solutions

Monoliths have contributed to hundreds of clinical batches of pDNA, including market supply.

  • COVID pDNA vaccine dosing estimated in low mg range.
  • HiP² Process Pack generic protocol.
  • Efficient 2-column process design.
  • Technology for large Plasmids in place (10-40+ kbp).
  • Process Analytical Technology in place.

Please check out here our comprehensive pDNA content overview.

 CIMac™ pDNA Analytical Column and relevant publications as application notes, posters and technical notes.

HiP² Plasmid Process Pack™ and related purification protocol, application notes, posters and other publications

Messenger RNA solutions

Monolith based  mRNA purification portfolio solves capturing and polishing  problem at manufacturing scale.

  • COVID mRNA vaccines dosing estimated in low to mid μg range.
  • BIA provides broadest portfolio of  chemistries.
  • dsRNA impurity removal.
  • Additional polishing feature: Sizing of ssRNAs.
  • Technology for large mRNAs in place (10-20+ kb).

Please check out here our fresh mRNA content overview.

CIMmultus™ Oligo dT, CIMmultus™ C4 HLD and related publications. SDVB and dsX Beta are avaialable for evaluation. For more information, contact us

VLP solutions

Monolith based  VLP purification  outperforms productivity of  density gradient  centrifugation based method  by  factor 200.

  • COVID VLP vaccine dosing estimated in E9-E11 range.
  • Capturing and polishing chemistries.
  • Chromatin removal technologies under development.
  • Process Analytical Technologies in place.

Appropriate BIA Separations analytical columns with related literature, such as application notes, and other publications.

Link to preparative products with related posters, and other publications.

AAV solutions

Recently, an innovative AAV-based COVID vaccine strategy was suggested: A Coronavirus Vaccine Project Takes a Page From Gene Therapy.

Monolith based AAV purification is highly accepted for  Gene Therapy vectors – BIA already has large scale market supply  experience.

  • Capturing and polishing strategies in place.
  • Chromatin removal technologies under development.
  • Market leading preparative empty/full capsid separation in place.
  • Analytical empty/full capsid fingerprinting in place.
  • Process Analytical Technologies in place.

Please check out here our comprehensive content overview.

For quantification of AAV samples you can use CIMac™ AAV full/empty Analytical Columns. More information can be found in related posters. With our new multimodal column we also made some improvement in terms of separation of empty and full capsids, what is shown in poster Improving separation of empty and full AAV capsids with a new multimodal column chemistry: CIMac EF beta.

CIMmultus OH, SO3 and QA columns are suitable for purification of AAV, with related application notes, posters, and other sources of knowledge.

Viral Vector solutions

  • Several capturing and polishing strategies available.
  • Chromatin removal technologies under development.
  • Process Intensification of Influenza DSP demonstrated (exemplaric).
  • Analytical fingerprinting technology in place.
  • Process Analytical Technologies in place.

Please check out here our comprehensive content overview.

CIMac™ Adeno Analytical Column with links to selected analytical applications notes and posters.

CIMmultus SO3 column for preparative purposes, with links to selected posters and other publications.

In the article Intensification of Influenza Virus Purification: From Clarified Harvest to Formulated Product in a Single Shift the successful  intensification of purification process is presented, whereas in the poster CIM Monolithic matrix as an efficient and polyvalent tool to prepare and analyze a cGMP compliant batch of recombinant Adenovirus serotype 5 shows another purification process reduced to one single chromatography step.

Resources