Bioconjugate Manufacturing | Non-GMP & GMP Manufacutring

Bioconjugate Manufacturing

Non-GMP Manufacturing

  • Non-GMP batches for GLP toxicology studies
  • Experienced team of process and analytical chemists
  • Scale: Upto 100g of toxin-linker – 50g antibody/protein drug conjugate

GMP Manufacturing

  • Dedicated cGMP analytical lab and knowledgeable analytical chemists
  • Analytical lab equipped with highly sensitive instruments for trace level analysis of cytotoxic compounds
  • Well-equipped and newly upgraded laboratories
  • Glovebox isolators for weighing cytotoxins and to carry out processes
  • Large scale purification equipment
  • Quality system and documentation in compliance with CFR guidelines
  • In-process and final product analyses and validated test methods
  • Upgraded facility to ensure smooth material and personnel flow
  • Documented procedures to receive raw material and disposition
  • Well established controls (engineering, administrative, and PPE controls) for handling cytotoxic materials
  • In-house real-time OEL testing to ensure high level safety for personnel and environment
  • Scale: 20–100 g based on process

 

Working with Abzena

Abzena’s bioconjugation services are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results in the minimum amount of time. Our clients widely regard us as professional and attentive partners who deliver quality results.

To get more information, a quote or to schedule a teleconference please contact us.

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