Your partner in lentiviral vector supply for all scales

Our robust and scalable lentiviral vector (LVV) platform process streamlines your path from preclinical to commercial manufacturing. This platform approach eliminates the need for costly development steps like engineering runs, shortening your timelines without sacrificing the quality of your vector. With our comprehensive regulatory support, global expertise, and experience supporting early, late phase, and commercial programs, Miltenyi Bioindustry is well equipped to help you achieve success, wherever you are in your CGT development journey.

Expertise you can trust
 

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FDA-approved commercial LVV supplier for TECELRA®

See press release

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96% GMP batch
 success rate*

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Less than 1 deviation per production lot released per year

*Based on data collected through 2024. Miltenyi Biotec does not guarantee any specific results, or that batches will fully conform with any particular specifications. Individual success rate may vary based on factors such as client specifications.

Benefits of our platform process

  1. Reduce COGS and shorten your development timeline: No need for costly steps like engineering runs and scaling studies – our process feasibility 4 L demonstration batch is predictive of GMP success, resulting in significant savings in time and costs.
     
  2. Fast track to GMP: Our platform process is established in fully operable cleanrooms, qualified materials and equipment already stocked, and cGMP batch records are already in place.
     
  3. Lighting-fast regulatory filing: Comprehensive global regulatory support – Regulatory Master File for the US and Canada, and Regulatory Support Files for the rest of the world.
 

From preclinical to GMP lentiviral vector in as little as 
8.5 months*: 

Timeline showing process steps from preclinical to GMP lentiviral vector

*Based on data collected through 2024.  Miltenyi Biotec does not guarantee that any specific delivery date(s) will be met.  Individual timelines may vary based on factors such as client’s stage of development and specifications.

Our lentiviral vector services for all scales

Vector design
evaluation and optimization

Vector design
evaluation and optimization

We work with you to design and optimize lentiviral vectors tailored to your gene therapy needs. 
Our team will evaluate your plasmid designs or create new ones to ensure safety, regulatory compliance, and efficiency.

We can assist with codon optimization, promoter selection, and sequence analysis while minimizing manufacturing costs. Using our robust third-generation platform, we prioritize consistent quality to meet your therapeutic goals.

Preclinical production

Preclinical production

We support your preclinical lentiviral vector production needs with scalable manufacturing from 4 L to 200 L, ensuring a seemless transition to GMP production. Using consistent technologies across scales, we provide high-quality vectors with detailed quality certificates. 

Our services include proprietary 293T packaging cell lines, plasmid support and cell banking. We can also parallelize cell and vector development to accelerate timelines and advise on regulatory strategies for IND-enabling activities.

Clinical &
commercial production

Clinical &
commercial production

We offer GMP-compliant vector production to support your clinical and commercial programs. Our standardized platform ensures safety, reproducibility, and efficiency using xeno- and serum-free processes at scalable volumes.

We guide your lentiviral vector production from risk assessment to commercial manufacturing. Our collaborative approach includes process characterization, quality-by-design methodologies, and global regulatory support, leveraging decades of expertise and state-of-the-art technology.

Key features of our platform process

  • Pre-defined upstream & downstream process
     
  • Pre-defined & validated analytics
     
  • 3rd generation serum-free suspension process
     
  • In-house plasmid design, manufacture, and supply
     
  • Regulatory Master File for US/Canada, Regulatory Support File for rest of world
     
  • Consultative support planning for clinical trials
     
  • Process characterization & validation to support commercialization
 

What does it look like to work with us

 

Lentiviral vector services for every cell type

<strong>Attain excellence with VSV-G</strong>

Attain excellence with VSV-G

Working with T cells? Lean on the experience of our vector experts to improve your vector performance, get to clinic quickly, and handle difficult constructs. 

<strong>Push the envelope with BaEV</strong>

Push the envelope with BaEV

Leverage the transduction power and safety profile of lentiviral vector for hard-to-transduce cell types (e.g. NK, HSCs, γδ T) with our BaEV pseudotyped LVV.

Global regulatory support

Our quality management system is specifically designed to ensure regulatory compliance and the highest product quality possible. We support you on your way to clinical readiness and market approvals, as well as country-specific client needs. Our Biologics Master File and Regulatory Support Files are recognized in more than 50 countries already. We are happy to support your project as well.

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