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Bioconjugation Services

Affordable, Customizable and Expert Solutions

NJ Bio has strong bioconjugation expertise with a broad range of proteins, linker-payloads, and conjugation technologies. We offer different service options to maximize value for our clients and perform bioconjugations at a stage-appropriate level. Our purified conjugates are accompanied by robust analytics to ensure products are well-characterized and have the stated purity. We can help in the selection of suitable linker-payloads that fit the biology of your target.

Discovery Service Options

Express
Conjugation

Will this mAb work in an ADC?

Validated linker-payloads for rapid conjugation
Application: In vitro/In vivo screens

Standard
Conjugation

Can this conjugate become a clinical candidate?
Larger-scale mAb conjugations
Narrow bioconjugation specification

Application: In vivo studies

Custom
Conjugation

What is the best clinical candidate?

Custom linker-payloads
Variety of DAR evaluations

Application: Toxicology studies

Express Conjugation: Early discovery and proof of concept (only for ADCs)

When you need an expeditious and cost-effective determination of whether you have a good ADC target, Express Conjugation is an excellent option. The Express Conjugation service allows you to quickly assess your target(s) using approved linker-payloads and stochastic lysine- or cysteine-based conjugation. In general, our turnaround time is 2 to 3 weeks and we require about 5 to 10 mg of mAb to produce between 2 to 5 mg of well-characterized ADC (with SEC, MS, UV and HPLC). The antibody does not need to be humanized at this stage and we can conjugate to a variety of IgG species and isotypes.

Example: You have 6 murine antibody candidates and want to screen in vitro with 1 or 2 approved linker-payloads (such as SMCC-DM1, MC-Val-Cit-PAB-MMAE, MC-MMAF, DXd(1) or CL2A-SN38) to help with your selection criteria. NJ Bio can rapidly help you study these leads in vitro and preliminarily in vivo to justify whether to move to the next stage.

Other services offered:
Our team can also perform cell-based functional assays such as cytotoxicity, internalization and binding assays.

Standard Conjugation

Standard Conjugation is our general conjugation platform for larger scale mAb conjugations and for other protein bioconjugates. Standard Conjugation allows access to a broader range of validated linker-payloads (e.g., DGN549, Tesirine, DM21C, or SPDB-DM4). We offer a fee-for-service option that will deliver larger quantities or conjugations to other proteins. Standard Conjugation is designed to help rapidly validate your target antigen or bioconjugate in vivo. The initial screen may have been carried out with small sampling of linker-payloads and you may need more data. Standard Conjugation will provide material for in vivo selection and narrow the payload release mechanism and mechanism of action (MOA). For a more complete project understanding, measuring internalization rates and antigen numbers will help with selection of linker-payloads. At this stage, we recommend utilizing validated payloads with stochastic conjugation but can also explore site-specific conjugation technologies. The goal of Standard Conjugation is to help you understand the effect of the MOA, the release mechanism, and the potency range required specifically for your biological target.

Example: You have proof of concept with MC-VC-MMAE that shows in vitro activity and some activity in vivo. You would like to assess payloads with different mechanisms of action such as topoisomerases or DNA damaging agent(s) in a larger in vivo study with a dose response. The Standard Conjugation option can help ascertain whether you will have a clinical candidate with an optimized ADC.

Other services offered:
We can conduct in vitro stability of the ADC in a mouse and/or human serum as an add-on and perform cell line validation techniques such as antigen numbers.

Custom Conjugation

You have an ADC and a target that shows clinical promise, but many questions remain to be answered. The Custom Conjugation platform will allow you to determine the best bioconjugate platform for preclinical development and lead optimization. Validated payloads do not always have the best therapeutic index (TI) for a particular indication. The Custom Conjugation development approach can identify the best conjugate to maximize clinical benefits, based on the biology of your indication. We can mix and match different payloads, linker technologies, and site-specific technologies to obtain the best candidate within your time constraints. We work to maximize stability, increase hydrophilicity, and ensure proper PK and release kinetics. This approach is cost- and time-effective to ensure that the best conjugate is brought forward. During lead optimization, larger quantities of material are needed for toxicology studies, which also requires larger quantities of linker-payloads. Through our flexible FTE program, resources are allocated as needed to efficiently provide high-quality material to keep the project moving forward rapidly.

Example: You have an ADC that shows tumor regression, but the TI is narrow. To maximize clinical success, an improvement to the TI is beneficial. This can be done with testing different site-specific technologies, increasing the hydrophilicity of the linker-payload and ensuring the ADC is optimized for the expected clinical dose range.

Other services offered:
NJ Bio can perform analyses of animal PK studies, in vitro and in vivo stability, and other cell-based assays to guide lead optimization.

Common Bioconjugation Requests

  • Protein and peptide drug conjugates
  • Carrier protein conjugates (e.g., with KLH, BSA, OVA)
  • Oligonucleotide conjugates
  • Glycoconjugates
  • PEGylated proteins
  • Other conjugates (e.g., fluorescent dye labelled, biotinylated, derivatized with chelators)

Development Services

Process
Development

DOE and scale-up to support preclinical development
Linker-payload scale-up
Prequalification studies
PK/PD assay development

Clinical Material
Manufacturing

Phase I and Phase II material (Q2 2021)
cGMP suite (Q2 2021)
Technical transfer

Process Development (Bioconjugation and Linker-Payload Synthesis)

If you are looking for Process Development support, our scientists have worked on projects that span the research and development spectrum. We have experience supporting the development of ADCs by optimizing, performing Design of Experiments (DOE), and scaling up material needed for preclinical development. We can scale up the chemistry of the linker-payload in-house, which will allow technical transfer as needed to a partner of your choice. The process we develop for your conjugation and linker-payload chemistry is assured to be robust for such transfers.

Our bioanalytical team can develop and validate methods during the preclinical stage that can be adapted and transferred to a clinical testing lab. The advantage of working with NJ Bio is all preclinical development activities can be performed under one roof.

Alliances
We have a strategic alliance with Lake Pharma to provide streamlined antibody-drug conjugate services. Under the terms of the alliance, LakePharma will manufacture and provide antibodies as starting materials for ADC development carried out by NJ Bio in a single, seamless workflow for clients, making therapeutic ADC manufacturing from initial antibody discovery to the production of the drug conjugates significantly more efficient both in time and expense.

Clinical Material Manufacturing

A cGMP suite in Bristol, PA is scheduled to be online in 3Q 2021 to support the production of Phase 1 and Phase 2 clinical trial materials. Our smaller-footprint facility will allow production of early clinical trial materials more efficiently and cost-effectively than larger commercial suppliers. Our goal is to have a seamless transition across method development, engineering runs, and production of key clinical materials between our sites in New Jersey and Pennsylvania.

Anatomy of an Antibody Drug Conjugate (read more)