Analytical Services

As a chemistry-based company, our proficiency in analyzing molecular behavior and properties is paramount to all our operations. At NJ Bio, our core focus lies in antibody-drug conjugates (ADCs) and small molecule synthesis/manufacturing. These endeavors necessitate comprehensive analytics to understand the intricacies of molecular structures and behaviors. ADCs, in particular, present unique challenges due to their composite nature, comprising both protein and small molecule components, making them susceptible to heterogeneity. Operating at the intersection of biology and chemistry, NJ Bio leverages its in-house expertise and cutting-edge instrumentation to offer advanced analytical services. Our capabilities enable us to thoroughly characterize proteins, macromolecules, small molecules, and their conjugates, ensuring uninterrupted support for our clients’ drug development programs.

Our analytical testing services encompass method development, method qualification and validation for characterization of small molecules (payloads, linker-payload, APIs, NTPs. etc.), nucleic acids (mRNA, DNA, oligonucleotide) and large molecules (mAbs, ADCs, AOCs, proteins, peptides) ranging from preclinical research to late-stage drug development. NJ Bio’s areas of expertise include but are not limited to Method Development and Validation, Quality Control Testing, Characterization Studies, Stability Testing, and Bioanalytical Services.

Precise, Accurate and Advanced Analytical Solutions

Analytical services involve rigorous testing, analysis, and interpretation of data related to drug substances and drug products. These services are aimed at ensuring the quality, safety, and efficacy of the pharmaceutical products throughout their lifecycle. NJ Bio’s state-of-the-art analytical laboratory and industry leading analysts produce cutting-edge product characterization research to guide your product development decisions. As we support our own award-winning, in-house, linker, payload, and antibody drug conjugate (ADC) activities, we apply that hard won experience to your challenging analyses and exacting manufacturing standards. We have the skills and facilities to partner with you from the early-stage development to late-stage regulatory filings and product launch, providing you with the continuity of commitment that safeguards project success. We consistently invest in the best analysts/ technicians and in maintaining and upgrading our top-of-the-line instrumentation to ensure seamless, advanced, and uninterrupted services for our clients. We take pride in bringing our clients success with their projects; as their business grows, so does ours.

Characterization of ADCs and other large molecules

Antibody-drug conjugates (ADCs) represent one of the most intricate classes of medicines. Due to their complex nature, both biological and small molecule characterization and analysis is of utmost importance as they role expands in oncology and beyond. The precise analytical characterization of this compound is crucial to fully understand their biological activity and toxicology. For example, the diverse array of conjugation site combinations resulting from lysine modifications in ADCs could serve as key quality attributes that enhance efficacy against an evolving population of cancer cells. However, it is imperative to conduct thorough and quantitative characterization of every batch of the ADC ensemble, regardless of its composition—whether it comprises millions of entities or a single one. This rigorous approach allows us to constructively model the inherent variability in patient outcomes, thereby establishing connections between adverse results and ensemble characteristics.

NJ Bio is an award-winning industry leader in synthesizing antibody-drug conjugates, their linkers, and drug payloads. NJ Bio Analytical is the characterization engine for these efforts which consistently solves the most intractable characterization challenges brought to us in-house, providing the NJ Bio production teams clarity and the way forward. In particular, our high-resolution mass spectrometry characterization offerings are the class of the industry.

We have developed a suite of offerings for ADC characterization tailored specifically to the demanding challenges and timelines that ADC development presents. And now we offer that extraordinary expertise and experience to the ADC community at large.

Our analytical tools for ADC Characterization

siteDAR: NJ Bio Analytical’s tool for complete ADC ensemble characterization. Determination of DAR and drug loading distribution by assigning and quantifying the extent of modification at every modified site and confirming the chemical integrity of all modifications.

CSI (Conjugation Site Identification): Ultrafast identification of modified sites, for rapid sampling of coupling strategies on new protein scaffolds early in ADC development, to ensure retention of critical protein function through conjugation.

Conjsort: New coupling strategies frequently produce anomalous results and even tried and true conjugation strategies can have non-canonical modifications that will have variable in vivo stability and affect the overall ADC performance. NJ Bio Analytical’s Conjsort, rapidly determines the existence of anomalous conjugations in our clients’ ADC batch.

mRNA Characterization

NJ Bio has strong in-house analytical expertise, state-of-the-art instrumentation dedicated to nucleic acid characterization and analysis, and offers customized method development services tailored to our clients’ specific constructs. From identity verification to purity assessment, impurity profiling, characterization, and safety testing, we provide a comprehensive suite of services to deliver reliable and accurate results that help accelerate our clients’ development timelines.

Small Molecule Characterization

Accurate analysis and characterization of small molecules are essential steps in drug discovery and development, demanding advanced analytical tools. NJ Bio houses advanced equipment such as high resolution and highly sensitive LC-MS, GC, HPLC/UPLC, NMR and other spectroscopic instruments to provide precise insights into the composition, potency, impurities identification and structural characterization of small molecules. These capabilities facilitate thorough characterization, crucial for advancing the drug development process.

Our dedicated team specializes in a wide range of analytical services tailored to support every stage of small molecule drug product development. From method development and validation to method transfer, our services cater to product development, clinical trial materials manufacturing, product release and stability testing. We can tackle technical challenges related to assay development, impurities identification & characterization and complete validation, ensuring the successful testing and release of small molecule drugs. Our analytical platform consists of flexible and robust instrument solutions designed to meet the diverse needs of small molecule analysis.

GMP Method Validation Process

The overall process of GMP-method validation starts from early-stage method development and method optimization to ensure the method is scientifically sound, followed by phase appropriate method qualification/validation before transfer to QC testing.

Analytical services play a crucial role in various stages of pharmaceutical development and manufacturing, particularly in early-phase activities and ensuring regulatory compliance during GMP testing and release.

Early Phase Analytical Method Development

This stage involves rapid analytical method development for characterization of drug substances, drug products, and any key intermediates using our platform methods. In early development, one of the primary purposes of analytical methods is to determine the potency of drug products to ensure the correct dose is delivered in the clinic. Our experts focus on identifying suitable analytical techniques and optimizing parameters like selectivity, sensitivity, accuracy, precision, and robustness. Analysts collaborate closely with chemists to develop methods suitable for the specific characteristics of the drug candidate, ensuring batches have a consistent safety profile.

Method Optimization and Ensuring Scientific Soundness of Methods

Analytical methods may be developed solely for or optimized for a particular product and product matrix. In either case, this involves a thorough optimization process, including incorporating the best-fit data reduction function. It is essential to verify that analytical methods are based on sound scientific principles and adequately validated to provide accurate and reliable results.

Validation/Qualification of Methods

Analytical method validation is a critical step in demonstrating a method’s suitability for its intended use. Our experts perform validation experiments to evaluate method performance characteristics and compliance with regulatory guidelines. Validation parameters typically include specificity, accuracy, precision, linearity, range, and robustness. Analysts conduct method qualifications to demonstrate that the design of the method is optimum and obtains reproducible results, ensuring the method is suitable for its application at this stage of development.

Method Transfer to QC/External CMOs

Method transfer involves effective transfer of analytical procedures from one laboratory to another, generally from the development stage to QC or external CMOs. We ensure a smooth transition, making certain that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended. Our experienced analysts provide detailed protocols, train personnel, and oversee the successful implementation of methods at the receiving site.

GMP Testing and Release

GMP testing ensures pharmaceutical products meet quality standards and comply with regulatory requirements before release. We perform a wide range of tests to assess product quality, including identity, purity, potency, and stability attributes. Our team utilizes a range of analytical technologies to promptly conduct release analytics, ensuring final products meet the required specifications for intended use.

NJ Bio is dedicated to maintaining the highest standards of quality and compliance in our GMP analytical operations. With the latest instruments, rigorous procedures, and advanced software solutions, we are well-equipped to meet the analytical needs of our clients while ensuring the safety, efficacy, and quality of the products.

Frequently Asked Questions

How do you ensure quality control throughout the process of analytical testing?

We follow a rigorous quality control approach by including method validation, instrument calibration, system suitability checks, and ongoing training of personnel.

Do you offer specialized analytical methods for evaluating the pharmacokinetics and pharmacodynamics of ADCs in preclinical and clinical studies?

We offer bioanalytical services including ligand-binding assays (LBAs) and highly sensitive hybrid LC-MS assays to evaluate pharmacokinetics, pharmacodynamics, and immunogenicity of ADCs in preclinical and clinical studies. To know more about our bioanalytical services, visit https://njbio.com/bioanalytical-services-for-adcs-and-other-bioconjugates/

How do you ensure the accurate quantification of both antibody and payload components in ADC samples?

We employ validated quantitative assays such as highly sensitive and high-resolution LC-MS methods to accurately quantify both antibody and payload components in ADC samples, ensuring precise measurement of drug-to-antibody ratio (DAR) and other critical parameters like unbound payload components.

Can you perform stability studies to assess the shelf-life and degradation kinetics of therapeutics under different storage conditions?

Yes, we conduct stability and forced degradation studies under various storage conditions (e.g., temperature, humidity) to assess the shelf-life and degradation kinetics of small molecules and large molecule therapeutics using various analytical techniques such as gel electrophoresis, LC-MS and other spectroscopic methods.

How do you ensure the reproducibility and robustness of analytical methods used for the characterization and quantification of large and small molecules?

We follow industry-standard guidelines (e.g., ICH, FDA) for method validation and conduct rigorous validation studies.