Drug Substance Manufacturing

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IDT Biologika is one of the world’s most experienced CDMOs in terms of expertise in developing and manufacturing of Vaccines, Viral Vectors for Gene & Immune Therapeutics, Oncolytic Viruses, Virus-Like Particles, and other Biologics from early-stage development through clinical to commercial scale. In Drug Substance Manufacturing, we provide master / working cell banks, master / working virus seeds, manufacture of bulk drug substance, and multiple manufacturing platforms. Working with our clients, we have been involved in the development and GMP manufacture of many of the world’s most notable vaccines developed over the last two decades.

Preclinical & Clinical Supply
Commercial
Supply
Tech
Transfer
Process
Design
Process
Validation
Upstream
Process
Downstream
Process

Preclinical, Clinical and Commercial Supply

Customers come to IDT Biologika at both clinical and commercial stages, and in each case, we look at the process and the needs of the project and tailor our approach and, if still undefined, the technologies we employ to optimize the outcome. If our client is ready to go straight into GMP manufacturing at BSL-2 with a clinical project, we will move towards that as quickly as possible.

If the process would benefit from further development, our PD and Manufacturing Teams are closely integrated, and we will work on development and scale clients’ processes to commercial volumes. Our Process Development Teams are cross trained in the GMP environment, so personnel are usually very close to the process throughout, making it as seamless as possible.

If a client has their micro-organism but needs development, we work with a range of platform technologies that can be used to optimize the process. We can manufacture a client’s cell bank for them. Our Analytical Teams can test all processes, sequencing viruses. We have a range of assays that are qualified, and we can also develop custom assays if needed. Our Regulatory Department also supports clients throughout the lifecycle of each product.

Tech Transfer

IDT Biologika uses a wide range of technology platforms to propagate live viruses and our Process Development Team will work in early-stage projects to identify the optimal technology. However, many of our clients already have an idea of their process and how it should work, especially if they have already done development work or even clinical production elsewhere. In these cases, we have considerable experience and proven SOPs to ensure a risk-mitigated transfer.

Process Design
Process Validation

Upstream and Downstream Processing

Upstream Processing / Manufacturing Platforms

IDT Biologika offers a range of cell culture techniques to manufacture live viruses, using adherent and suspension technologies to create large surface areas to optimize production and virus yields.

Adherent

  • HyperStack Cell Factories
  • iCELLis®
  • Roller Bottles

Suspension

  • Stirred tanks with microcarrier technology

Downstream Processing

IDT Biologika has significant experience developing and implementing downstream purification processes for recombinant proteins and viruses. Initial purification may include clarification of initial harvest material using either:

  1. Depth filtration and/or centrifugation and chromatography technologies (Ion-Exchange, Affinity, Size Exclusion)
  2. Tangential flow filtration (TFF) systems (flat-sheet, hollow fiber) – purified proteins and virus can undergo concentration with subsequent diafiltration with formulation buffer.

Purified bulk drug substance (BDS) can then be sampled and dispensed into appropriate final containers.

Drug Substance Manufacturing Platforms

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Cell Factories
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Single-Use Stirred Tank Bioreactors
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iCELLis® Bioreactors
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Roller Bottle Technology
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