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Viral Vectors Viral Vectors

Viral Vectors

Our viral vector manufacturing facility can cater to both – cell and gene therapy and viral vector vaccines.

GMP manufacturing capability supports any preclinical, clinical, and commercial scale manufacturing of a wide range of viral vector platforms – Lenti, Adeno, Retro, and Baculo.

Driven by scale flexibility, we can support on a wide scale of operation – 0.5L – 1,000L. Utilization of single-use technologies enable prompt change over by omitting cleaning validation.

We undertake an integrated approach to safety and quality management systems, which enable greater flexibility by leveraging pan – organizational experience in managing regulatory audits, and compliance to statutory norms.

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Plasmid production and characterization

Lentivirus: Gag-pol, VSVG, Rev, and Transfer plasmids (3rd Gen system)

Recombinant adeno-associated virus (rAAV): Packaging plasmid (Rep-Cap), helper plasmid (VA-E2A-E4), and transfer plasmids

  • GMP like
  • Digestion and sequencing

Upstream process development

  • HEK293T suspension / adherent
  • Transfection (PEI or other methods)
  • Shake flask, wave bioreactors, stirred-tank reactor, and iCELLis

Purification

Purification is done using ultracentrifuge or chromatography

  • Clarification and concentration, TFF, and Benzonase
  • Ultracentrifuge or chromatography (IEX, AEX, affinity, and SEC)
  • Concentration and buffer exchange, TFF, and sterile filtration

QC and release

Release assay

  • General/physical properties
  • Identity
  • Safety
  • Purity
  • Strength
  • Potency

Viral Vaccine

Our viral vaccine manufacturing facility can cater to both – conventional and novel viral vaccines.

Our manufacturing capability (GMP/ Non-GMP) supports preclinical, clinical, and commercial scale manufacturing of a wide range of viral vaccines in suspension or combination of adherent and suspension methods.

We can support large- scale vaccine manufacturing – 2x1KL per batch run in a single-use platform. Manufacturing is supported by an in-house capability of viral vaccine development and MSAT.

Why Aurigene Viral Vectors Services?

2KL installed capacity

Low lead time to manufacturing.

30+ tech operation professionals

Zero liquid discharge capability

Integrated approach to safety and quality management systems

One-stop shop across the product life cycle – proof of concept to commercial

Integrated QC testing and release

Virtual Tour

 

Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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