Product/Service

Future-Ready Development

Source: Landmark Bio
GettyImages-1181392775 lab, research

Ask us to strategize with you on your therapeutic development approach, design and execute experiments, plan, source, make and deliver your products, and help you write and review regulatory documents and interact with the agencies. We do more than a typical manufacturing organization, and we do it better.

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Therapeutic Discovery Research

  • CAR1 engineering and gene editing (viral/non-viral)
  • Cellular product design and cell engineering
  • Product quality profile development
  • Candidate screening and selection

1 CAR: Chimeric antigen receptor

Process Development

  • Cell therapies (autologous, allogeneic, iPSC1)
  • Genome editing (viral/non-viral)
  • Viral vector (AAV2, LVV3)
  • mRNA
  • Lipid nanoparticles (LNP)
  • Extracellular vesicles (EV)

1 iPSC: Induced pluripotent stem cells
2 AAV: Adeno-associated virus
3 LVV: Lentiviral vector

Analytical Development

  • Method development and optimization
    • Flow cytometry
    • PCR
    • HPLC etc.
  • Product characterization

GMP Manufacturing

  • Viral vector (up to 200L scale)
  • Cell processing
  • mRNA enzymatic synthesis
  • Lipid nanoparticle formulation
  • Fill/Finish (vial and bag)

Quality Control

  • Environmental monitoring
  • In-process testing
  • Specification testing
  • Stability testing
  • Method transfer, qualifications, and validation

Development CMC/Consulting

  • Therapeutic discovery, development, CMC and regulatory strategies
  • Writing and reviewing regulatory submissions
  • Interactions with health authorities

State-Of-The-Art Facility

 

 

 

44,000 sq. ft. integrated facility in Watertown, MA

Innovation and Development Labs

  • Process Development
  • Analytical Development
  • Translational Research

GMP Manufacturing

  • 5 Cell Processing Suites
  • 2 Viral Vector (upstream and downstream) Suites
  • 1 mRNA and LNP Suite
  • 1 Fill and Finish Suite

Quality Control Labs

Office Space

 

 

 

 

 

 

“Landmark Bio’s facility serves as a transformational development center for our talented research community to advance technologies that manufacture and distribute breakthrough therapies.”

— Cynthia Barnhart, MIT Provost, Landmark Bio Board Member

Landmark Bio