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Frequently Asked Questions about ADCs
Pharmaceuticals

Frequently Asked Questions about ADCs

 

General questions about ADCs

Antibody-Drug Conjugates (ADCs) combine highly potent chemotherapy agents (payloads) with target-specific monoclonal antibodies through a covalent linker molecule. These biomolecules result in a target-tracking pharmaceutical showing strong efficacy in cancer therapies.
Discover the 3 facts you need to know about Antibody Drug Conjugates.

The vast majority of ADCs are comprised of a monoclonal antibody conjugated to a cytotoxic payload.
However, there are also many different forms of conjugated therapies including non-cytotoxic compounds as well.

Antibody-Drug Conjugates are constructed from three primary parts: mAb, linker, and payload. The most common mAb used is either fully or partially humanized IgG1. The linker used is either cleavable or non-cleavable, and the linkage is carried out through a variety of different conjugation technologies. The most common of those are stochastic cysteine, stochastic lysine, and engineered cysteine (site-specific). Common payloads include auristatins, maytansins, PBDs and irinotecans, with a trend towards increased diversity. 
Combining these elements creates the broad diversity of ADC molecules currently in pre-clinical and clinical development.

 

ADC development services

The Antibody-Drug Conjugates outsourcing process is complex and should be initiated as early as possible.
Typically, this should begin as soon as a target molecule is identified and chosen for clinical trial testing.
Novasep can help with initial process definition as well as a technical transfer of a more advanced or fully developed process.

Novasep applies a rigorous development plan to all projects in order to ensure manufacturing success.
This typically includes process robustness development through statistical experiments (DoE) and is followed by stepwise scale-up to manufacturing scale operations.
Watch our webinar recording to discover the importance of Design of Experiment (DoE) for ADC development.

We have a specific offer tailored for preclinical projects which we call Fast Track Offer.
This offer aims at generating the first ADC lead candidates at lab scale to support development of preclinical programs.
Through this first pre-clinical program, Novasep's experts will also provide recommendations for further process and analytical development.
Discover our case study about the generation of first ADC samples for preclinical studies!

Novasep can offer its proprietary chromatography equipment as well as decades of highly-potent chromatography experience to facilitate ADC manufacture.
Visit our preparative chromatography dedicated webpage to learn more!

 

ADC manufacturing services

Yes, Novasep has experience in manufacturing clinical cGMP batches.
Discover our case study about the successful cGMP conjugation of a novel ADC for phase 1 clinical trials.

Find out the estimated timeline for an ADC project:

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Discover the clinical stages that Novasep can handle for ADC manufacturing:

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Learn more about conjugation at Novasep:

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Novasep has experience in conjugation with the main classes of ADC payloads (Maytansines (DMx), Auristatins, PBD dimers) as well as proprietary customer payloads.
Visit our ADC payloads dedicated webpage to learn more!

Yes, Novasep has been a specialist in highly-potent synthesis and purification for more than 30 years, with particular excellence in chiral molecule separation and impurity reduction. For the past 12 years, Novasep has been manufacturing commercial ADC payloads as well as many different molecules currently in clinical trials.
Visit our webpage to learn more about production and development services for ADC payloads!

Integrating payload and conjugation on one site decreases overall development time, lowers supply-chain complexity, and simplifies CDMO management for our customers. We have the same quality system in place for HPAPIs and ADCs. In addition, it allows for a more robust development process through collaboration between the synthesis and conjugation teams should any unexpected issues arise during development.

Learn more about our ADC manufacturing services:

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The bulk drug substance is frozen upon completion and shipped on dry ice for fill and finish operations.

Learn more about bioburden and endotoxin monitoring at Novasep:

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Discover Novasep's analytical capabilities for ADCs:

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Discover Novasep's analytical services:

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Find out the typical list of ADC release testing methods:

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Learn more about analytical equipment for ADCs:

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To learn more about Novasep's capabilities for ADC characterization:

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Yes, at Novasep we propose stability testing of your ADC following ICH guidelines.
We are equipped with climate chambers covering the typical ICH storage conditions:
• ≤ -65°C
• -20 ± 5 °C
• 5 ± 3 °C
• 25 ± 2 °C, RH: 60 ± 5 %
• 40 ± 2°C, RH: 75 ± 5 %

All our climate chambers are monitored 24/7.

At Novasep we propose an integrated team of analytical experts working on your ADC. The analytical team handles the full life cycle of the different analytical methods necessary for in-process control and release testing.
We can propose method development activities from scratch or just optimizing the customer method.
We have qualification and validation experts that will take your method to the necessary validation level for cGMP clinical or commercial production.

 

Bioconjugation equipment and scale-up

Novasep has been involved with various conjugation chemistries over the years, from Stochastic Cysteine, Stochastic Lysine, Site Specific Cysteine, to Site specific with Fc recognition.

Discover Novasep's capabilities for bioconjugation:

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Learn more about equipment utilization at Novasep:

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Quality & Regulatory affairs

The Le Mans facility (France) has been audited every two years since 2010 by the FDA and ANSM. The site also regularly has customer audits and has a sterling record with no major citations in the past 5 years. (Last FDA inspection: No 483)

Novasep can help its customer to define the regulatory strategy of submission and provide regulatory expertise for BLA submission.

To support you with filing ADC with Health authorities and Regulatory affairs, Novasep can:
• define the regulatory strategy, support of writing regulatory file
• submit the initial registration directly to the Health Authority if submission of DMF/ASMF
• answer questions from the Health authority
• update the regulatory file and compliance review after approval

Discover Novasep's Quality Assurance system:

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Project management

Novasep defines a dedicated project manager at the beginning of all projects to coordinate actions and communication throughout the process. The project manager will facilitate regular update meetings along with preparing action tables and summaries to ensure transparency and efficiency throughout the project.

Scope changes are handled by the project manager in collaboration with the client and the development team. In the event of necessary development beyond that stated in the initial scope, the customer, development team, and project manager will work together to quickly find an acceptable path forward in order to ensure the success of the project.




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Downloads
  • ADC Bioconjugation: development and cGMP manufacturing of a candidate for Phase I clinical trials
    ADC Bioconjugation: development and cGMP manufacturing of a candidate for Phase I clinical trials
    Discover how we supported one of our clients with the cGMP bioconjugation of an ADC for Phase I clin...
    Download +
  • A full range of CDMO services for ADCs
    A full range of CDMO services for ADCs
    Find out the solution adapted to your needs with Novasep's fully integrated CDMO services for ADCs
    Download +
  • Frequently Asked Questions: ADCs
    Frequently Asked Questions: ADCs
    Learn more about ADCs in our FAQ!
    Download +
  • Case study: Successful cGMP conjugation of a Novel ADC for phase I clinical trials
    Case study: Successful cGMP conjugation of a Novel ADC for phase I clinical trials
    Novasep was approached by a top 10 pharmaceutical company to help with the manufacture of a cGMP ant...
    Download +
  • Case study: ADC payload, successful process development and manufacturing
    Case study: ADC payload, successful process development and manufacturing
    Novasep was approached by a top 10 pharmaceutical company looking for a reliable partner to manufact...
    Download +
  • Case study: Generation of first ADC lead candidates at lab scale to support pre-toxicology development program
    Case study: Generation of first ADC lead candidates at lab scale to support pre-toxicology development program
    Novasep was approached by a biopharmaceutical company developing a preclinical ADC consisting of IgG...
    Download +
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