A secured, scouted fast-track from discovery to first GMP batches delivered for clinical trials

Many of the decisions made during the early days of building and compiling the manufacturing information for your IND submission will directly impact the future cGMP manufacturing operations and simply become foundational for the commercial viability of the developer’s pipeline of therapies.

Lonza’s Early Advantage program for IND success is designed to arm developers with the tools and expertise to anticipate these future outcomes and challenges, make the best possible educated decisions early-on, all while accelerating the journey to compiling your IND application and starting clinical trials.

Download the Early Advantage white paper

From Bench to IND and first cGMP batches delivered

Tissue
acquisition

  • Tissue acquisition (if applicable)
  • GMP banking (if applicable)

Feasibility

  • Manufacturability
  • GMP feasibility
  • Process definition

Analytics

  • Method development
  • Implementation
  • Stability studies

Process
development

  • Scale studies
  • Yield optimization
  • Small scale toxicology batch

Clinical cGMP material

  • cGMP readiness
  • At scale toxicology batch
  • cGMP batch
  • Regulatory support

A dedicated Bench-to-IND program for your modality

Our Early Advantage Bench to IND Program individually covers all key CGT modalities, from CAR-T therapies, where we have publicly supported key pioneers of the CGT space from early stage to commercial, to Natural Killer (NK) Cells, iPSCs, MSC, Viral vectors including Lentivirus and Adeno-Associated Viruses and Exosomes-based therapies.

Download the white paper

Cell and Gene
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