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Manufacturing Services
Comprehensive, Scalable and Advanced CDMO Services
NJ Bio is a premier CDMO (Contract Development and Manufacturing Organization) recognized not only for our state-of-the art facility and equipment but also for deep knowledge and expertise in complex chemistry, bioconjugation and analytics. We specialize in the development and GMP manufacturing of antibody-drug conjugates (ADCs), complex bioconjugates, mRNA, oligonucleotides, antibody-oligonucleotide conjugates, linker payloads and other advanced therapeutics. Our value lies in our speed, problem-solving capabilities, and collaborative approach. NJ Bio’s integrated CDMO services support drug development programs from early discovery through GMP manufacturing, accelerating your path from preclinical candidates to clinical assets. Our team of experienced scientists and manufacturing experts supports a wide range of research projects and is dedicated to delivering services tailored to the unique requirements of each program.
GMP Clinical Manufacturing Facility:
Our purpose-built manufacturing suites enable unified coordination from preclinical development to process optimization and clinical manufacturing. This site features:
• Dedicated facility for streamlined drug substance manufacturing
• Expedited drug substance (DS) delivery with flexible capabilities at a single site
• GMP-Compliant Suites for ADCs, mRNA, and other bioconjugates
• Stable supply chain management system
• Rapid Tech Transfer
• On-site analytical and QC capabilities
Clinical manufacturing or clinical trial material manufacturing (CTM) is the process of manufacturing therapeutics to support clinical research. NJ Bio’s GMP suites are equipped and specifically designed to manufacture Phase 1 and Phase 2 clinical trial materials. We offer flexible and cost-effective alternatives to larger commercial suppliers, while maintaining quality and compliance. The strategic positioning of our R&D and manufacturing facilities enables a smooth transition throughout the entire process — from screening molecules, method development and engineering runs to the production of clinical materials. This integrated project management approach ensures consistent delivery of high-quality products that meet the most stringent quality standards.
Our facility has been purpose-built to meet the standards of international regulatory boards and to efficiently scale production to fulfill the increasing requirements of clinical trials. Single-use technology is employed for various processes, including solution preparation, synthesis, downstream chromatography, and filtration. Single-use or disposable equipment, especially in the production of ADCs, reduces the likelihood of cross-contamination, while simultaneously enhancing product efficiency by shortening product changeover durations, intra-batch cleaning, and maintenance cycles.1
NJ Bio has implemented a comprehensive quality management system in strict adherence to current Good Manufacturing Practice (cGMP) regulations. The facility encompasses both pilot and clinical scale capabilities, and we have implemented a Phase-appropriate Compliance (PAC) quality system to meet the regulatory standards set forth by agencies such as FDA, EMA, MHRA and others. This system not only ensures compliance but also enhances the efficiency, effectiveness, and credibility of our processes.
Chemistry Excellence Across Modalities & GMP Platforms
ANTIBODY DRUG CONJUGATES
Integrated solutions for ADC development & manufacturing
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BIOCONJUGATION
Bioconjugation of variety of linker-payloads, proteins, peptides & oligos
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PAYLOADS & LINKERS
Synthesis and characterization of high-potency payloads and linker systems
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mRNA
Wide range of customized mRNA synthesis & manufacturing services
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ANTIBODY-OLIGONUCLEOTIDE CONJUGATES
Oligonucleotide modification & custom AOC synthesis
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ADC CDMO Services
As a trusted ADC CDMO partner, NJ Bio offers comprehensive ADC manufacturing solutions from preclinical candidate through clinical-grade production. Our facility is well-equipped to handle the intricate processes integral to ADC production. With a strong expertise in bioconjugation, linker-payload development, synthetic chemistry, and handling high-potency compounds, our team can address challenging issues encountered during the development and manufacturing of investigational ADCs for clinical trials thus expediting the entire drug discovery process. Our strong experience in early research and development, and extensive knowledge of novel linkers, payloads, and conjugation technologies, enables us to streamline the drug development pipeline, ensuring a smooth transition from discovery to clinical material production of novel therapeutics.
Our high potency lab is designed to handle derivatives or analogs of highly potent cytotoxic agents, whether of natural or of synthetic origin, such as auristatin, maytansinoids, duocarmycins, and more. We provide extensive services for ADC development including but not limited to process development and optimization, bioconjugation, novel linker-payload technology and production of ADC drug substance (DS).
We also develop robust analytical methods to assess the purity, stability, and quality of produced ADCs, offering an advanced bioanalytical testing platform. Stringent quality assessment measures are implemented for in-process materials, ensuring consistency of the ADC product.
Bioconjugation CDMO Services
A bioconjugation CDMO is a specialized service provider that possesses the necessary skills and platform to support the development, chemical conjugation, and GMP manufacturing of bioconjugates. With our focused infrastructure and experienced teams, NJ Bio provides CDMO services for the development and manufacturing of ADCs and AOCs, enabling targeted delivery of therapeutics. We focus on chemistry to solve complex development and scale-up challenges and maintain stability and efficacy of the bioconjugate. We offer strong expertise in the conjugation of drug linkers to monoclonal antibodies (mAbs) with specialized laboratories equipped to handle highly potent compounds. Our team excels in designing and delivering optimized bioconjugation strategies and high-quality bioconjugate products tailored to our clients’ specific needs. We provide comprehensive bioconjugation services for the development of bioconjugate therapeutics, from concept to GMP manufacturing. Leveraging our advanced conjugation technologies and state-of-the-art facility, we optimize costs and accelerate timelines to market.
Payload – Linker Manufacturing:
Our bioconjugation CDMO expertise extends to the design, synthesis and scale-up of chemical payload-linkers for ADCs. NJ Bio offers an integrated range of services encompassing discovery, development, and GMP manufacturing specifically for chemical payloads and linkers. Our capabilities include performing a wide range of chemical reactions, as well as handling isolation, purification, and analytical method development and validation for release and stability testing. At our GMP high potency lab we can produce chemical payloads in gram- to kg-scale,
We are adept in developing and scaling up processes related to small molecules and payloads designed for ADCs, custom synthesis of novel linker-payload variants, strategic designing of linker-payloads, and executing process development for the seamless transition from development to scale-up and manufacturing. We consistently work towards simplifying synthetic routes, identifying optimal linkers, and synthesizing novel payloads with high potency.
Developing and scaling up payloads pose significant challenges due to their cytotoxic nature and complex molecular structure. The intricate synthetic routes required for their production are time-consuming and expensive. Moreover, the necessity for high-containment facilities adds complexity to both development and manufacturing. Traditional synthetic methodologies used by chemists are often inadequate for these toxic payloads. Consequently, expertise in optimizing synthetic routes becomes crucial to enhance cost efficiency, quality, and manufacturing timelines.2 Our team specializes in the development and optimization of synthetic routes, particularly for the highly toxic molecules used in ADCs.
What we offer
Antibody-Drug Conjugates
ADC CDMO Integrated Platform
Chemistry-focused approach
Dedicated team for clinical projects
Stability & Release Testing
Bioconjugation CDMO
DAR optimization & control
ADC, AOC & other bioconjugates
Process Development & Tech transfer
Payload-Linker Manufacturing
Custom payload-linker synthesis
High-containment facility
Modular linker chemistry platform
mRNA Manufacturing
NJ Bio delivers expert mRNA CDMO services including custom synthesis and development of functional mRNA sequences for therapeutic applications. Our combined expertise in chemistry and biology enables us to deliver quality solutions for the development and manufacturing of mRNA sequences. Our team specializes in customizing functional mRNAs, carrying out mRNA synthesis via in vitro transcription (IVT), producing unmodified/ modified NTPs and capping agents, and provides comprehensive technical support throughout the research program. Leveraging our expertise, we can produce high-fidelity mRNA sequences of diverse lengths and functions, ensure optimal expression, mitigate immunogenicity concerns, and enhance the overall stability of the mRNA product to align specifically with our clients’ project requirements.
What we offer
mRNA Manufacturing
In vitro transcpription (IVT) and custom mRNA synthesis
Modified and Unmodified NTP incorporation
Capping strategies and poly(A) tailing
Purification & quality control for high-purity, high stability mRNA
Immunogenicity mitigation and sequence optimization
High-fidelity, scalable mRNA manufacturing solutions tailored to a programs' specifications
Antibody-Oligonucleotide Conjugates (AOCs) and Oligonucleotide Synthesis
NJ Bio offers advanced capabilities in the development and manufacturing of antibody-oligonucleotide conjugates (AOCs) as part of our expanding CDMO services. Antibody-oligonucleotide conjugates combine the gene modulating function of oligonucleotides with the targeting precision of antibodies. Our robust platform supports the design, synthesis, and early-phase GMP manufacturing of AOCs. Our team possesses deep cross-disciplinary expertise in bioconjugation, oligonucleotide synthesis, and modification, enabling the development of high-quality AOC constructs optimized for stability through advanced CDMO techniques. Whether your program requires custom oligonucleotide production, complex bioconjugation, or specialized CDMO support for ADCs or AOCs, NJ Bio provides comprehensive, regulatory-compliant solutions for unique needs of your program.
What we offer
Antibody-Oligonucleotide Conjugates
Site-selective conjugation of oligonucleotides
Control of oligo-antibody ratio (OAR)
In house synthesis of high-purity, chemically modified oligonucleotides
Oligo optimization & conjugation compatibility studies
Scalable conjugation workflows
Process development & Tech transfer
Comprehensive Analytical and Quality Control Services
At NJ Bio, our robust analytical and QC platform enables comprehensive testing & characterization at a single site, in close collaboration with both drug development and manufacturing teams. We also identify and characterize the process related and degradation impurities in drug substances and drug products using our high-resolution mass spec and NMR instruments. This integrated approach streamlines the process, reduces time and cost, and provides quality control at every stage of drug development. To know more details about our analytical services click here.
Integrated Payload Manufacturing Expertise with Cohance Lifesciences
Through our recent acquisition by Cohance (Previously Suven Pharma), NJ Bio now offers large-scale and commercial payload manufacturing capabilities. Cohance is one of the leading global suppliers of s-Trione, exatecan, SN-38, and offers access to a wide range of camptothecin derivatives. This integrated platform enables seamless transition from early development to commercial-scale supply of high-quality cytotoxic payloads for ADC programs. To learn more about our combined payload manufacturing services click here.
Why Choose NJ Bio as Your ADC CDMO Partner?
At NJ Bio, our mission is to provide innovative, scalable, and efficient CDMO services that drive the success of our clients’ therapeutic programs in oncology, gene therapy, and beyond.
References
(2) Goundry, W. R., & Parker, J. S. (2022). Payloads for antibody–drug conjugates. Organic Process Research & Development, 26(8), 2121-2123. https://doi.org/10.1021/acs.oprd.2c00227
Frequently Asked Questions (FAQs)
The timeline varies based on project scope. On average, the GMP manufacturing process for ADCs can take approximately 9-12 months from the initiation to GMP release, depending on the availability of mAb and linker-payload. This includes tech transfer, process development/optimization, scale-up batches, impurities characterization, tox/engineering batch manufacturing, analytical method development & qualifications, R&D stability studies, reference standard generation and GMP batch manufacturing and release.
Does NJ Bio offer stability testing for the manufactured products?
NJ Bio offers GMP release & GMP stability testing ensuring quality, safety, and efficacy of the product. Our stability testing includes long-term stability studies (25°C ± 2°C/60% RH ± 5% RH, 2- 4 °C, – 20 °C & -80 °C), intermediate stability studies (30°C ± 2°C/65% RH ± 5% RH) and accelerated studies (40°C ± 2°C/75% RH ± 5% RH) as per ICH guidelines. We provide a detailed stability report to our clients and offer GMP reference standard qualification services.
Does NJ Bio offer analytical development services for the products?
NJ Bio has a dedicated and experienced analytical team focused on developing robust analytical methods to characterize small molecules (payload, payload-linkers, modified NTPs, etc.), mAbs/ADCs (protein, peptides, mAbs, oligopeptide/protein conjugates) and mRNA for the critical quality attributes. Our analytical development team utilizes a range of techniques, including HPLC/UPLC instruments with UV/PDA/ELSD/RI/MALS/SQD detectors, high resolution mass spectrometry instruments (multiple Waters Xevo G3 QTOF, Xevo G2 QTOF & TOF), highly sensitive mass spectrometry instruments (TQ-S, TQ-D, TQ-absolute, Sciex Triple Quad) PA 800 Plus, ProteinSimple Maurice, NanoDSC and other spectroscopic instruments such as soloVPE, UV-VIS, Karl-Fisher & FTIR. NJ Bio also has a dedicated GMP bioassay lab within quality control department which offers a broad range of standard and specialized cell-based assays and molecular assays to support GMP release and stability studies.
Do your manufacturing processes adhere to the regulatory requirements of key agencies such as the FDA, EMA, MHRA, and other relevant authorities?
Yes, our manufacturing processes are designed and would be executed with strict adherence to regulatory standards, including those set by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Medicines and Healthcare Products Regulatory Agency (MHRA).
Do you use single-use equipment in your GMP manufacturing processes?
Yes, our manufacturing processes primarily rely on single-use equipment to ensure product quality and streamline operations.
