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NJ Biopharmaceuticals LLC

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N BRUNSWICK, New Jersey, US

About NJ Biopharmaceuticals LLC

NJ Biopharmaceuticals LLC (d/b/a NJ Bio) is a CRO that provides integrated chemistry and biology services to clients from the biotech and pharma sectors. Main service areas include multistep organic synthesis, medicinal chemistry, bioconjugation, antibody-drug conjugates, and flow chemistry. The... Show more »

NJ Biopharmaceuticals LLC (d/b/a NJ Bio) is a CRO that provides integrated chemistry and biology services to clients from the biotech and pharma sectors. Main service areas include multistep organic synthesis, medicinal chemistry, bioconjugation, antibody-drug conjugates, and flow chemistry. The company is headquartered in the New Jersey Bioscience Center in North Brunswick, NJ, with additional chemistry facilities in Bristol, PA, and a satellite office in Cambridge, MA. NJ Bio has Amar Chemistry Pvt. Ltd. as an exclusive partner in India for flow chemistry services as well as chemical process R&D.

NJ Bio has a strong background in synthetic organic chemistry and protein-based biopharmaceuticals and is an integrated service provider with expertise in the following areas:

  • Antibody-drug conjugates (ADCs), bioconjugation to proteins and biomaterials, linker chemistry design for conjugations, ADC constructs, and process development for small molecules and ADCs.
  • Multi-step customized flow chemistry synthetic routes for drug intermediates and APIs in collaboration with Amar Chemistry Pvt. Ltd., along with a unique offering to design custom flow chemistry equipment in collaboration with experts at Amar Equipment Pvt. Ltd.
  • Medicinal chemistry from lead generation via lead optimization to scale-up, with the option of engage into blended FTE services with Amar Chemistry Pvt. Ltd.
  • Production of research-grade proteins and antibodies.
  • Cell-based functional assays, including cytotoxicity, binding, and internalization.
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Our Services (14)


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Protein PEGylation

Price on request

NJ Bio can offer PEGylation services for proteins and small molecules to significantly improve the physicochemical properties of a drug, increase the solubility of poorly soluble molecules, and reduce the immunogenicity of biopharmaceuticals. The following is a list of the offered services: - Protein PEGylation - Peptide... Show more »

NJ Bio can offer PEGylation services for proteins and small molecules to significantly improve the physicochemical properties of a drug, increase the solubility of poorly soluble molecules, and reduce the immunogenicity of biopharmaceuticals. The following is a list of the offered services: - Protein PEGylation - Peptide PEGylation - Antibody PEGylation - Small molecule PEGylation - Purification of PEGylated products - Process development of PEGylated products - Custom synthesis of PEGs - Development of PEGylated biosimilars

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Antibody-Drug Conjugate (ADC) Development

Antibody Drug Conjugate Development
Price on request

Antibody-drug conjugates (ADC) are comprised of an antibody to which is attached a cytotoxic agent through a linker. The type of linker chemistry used play significantly affects the potency, selectivity, and the pharmacokinetics of the resulting ADC product. NJ Bio can offer a variety of linkers tailored for specific proteins... Show more »

Antibody-drug conjugates (ADC) are comprised of an antibody to which is attached a cytotoxic agent through a linker. The type of linker chemistry used play significantly affects the potency, selectivity, and the pharmacokinetics of the resulting ADC product. NJ Bio can offer a variety of linkers tailored for specific proteins and targets to affect potency, selectivity, and pharmacokinetics of resultant ADCs. These linkers will be selected based on the type of protein, antibody and desired release mechanism for drug molecules keeping long term stability of the protein as one of the priorities.

NJ Bio has a variety of highly potent warheads/payloads in stock for advancing its clients’ ADC programs. The following is a list of several classes of payloads in our toolbox for preparing ADCs or protein drug conjugates (PDCs):

  • PBD dimer analogs
  • Duocarmycin analogs
  • Auristatin analogs
  • Maytansine analogs
  • Exatecan and SN-38 derivatives
  • Additional payloads (details available on request)

 

Bioconjugation services include the following:

  • Design and synthesis of potent cytotoxic compounds, linkers, and payload-linker constructs.
  • Preparation and purification of bioconjugates from milligram- to gram-scale.
  • Modification of carbohydrates, polysaccharides, and glycoconjugates.
  • Preparation of fluorescent probes.

 

Conjugation methods employed at NJ Bio include:

  • Cysteine conjugation
  • Lysine conjugation
  • Conjugation to engineered cysteines and non-natural amino acids
  • Enzymatic conjugation

 

NJ Bio also offers expeditious and affordable Express Conjugation Services using Lysine and Cysteine Conjugations.

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Chemical Synthesis

Price on request

NJ Bio's team of experienced organic chemists can tackle the synthesis of complex molecules, including chemical intermediates, drug metabolites, process impurities, degradants, reference compounds, preclinical drug candidates, and other organic molecules from diverse industries.

Our custom synthesis expertise... Show more »

NJ Bio's team of experienced organic chemists can tackle the synthesis of complex molecules, including chemical intermediates, drug metabolites, process impurities, degradants, reference compounds, preclinical drug candidates, and other organic molecules from diverse industries.

Our custom synthesis expertise includes:

  • Carbohydrates (including glucuronides)
  • Catalytic hydrogenations
  • Chiral synthesis and separations
  • Flow chemistry
  • Macrolides
  • Metabolites/ Impurities
  • Nucleosides and Nucleotides
  • Organic materials
  • Organometallic compounds
  • Oxidations
  • Peptide/amino acid synthesis
  • Polycyclic aromatic hydrocarbons
  • Photochemistry
  • Pressure reactions
  • Labelled compounds with stable isotopes including deuterium, 13C, 15N
  • Steroids
  • Suzuki, Stille, Buchwald-Hartwig and other coupling reactions
  • Sulfonylations
  • Toxic/potent compounds
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Cytotoxicity Assays

Price on request

NJ Bio utilizes in vitro cell cytotoxicity assays to analyze the potency of toxins or antibody-drug conjugates (ADCs). Each ADC will be tested against a variety of cancer cell lines expressing the targeted surface antigens and normal cell lines to evaluate in vitro safety. These assays quantitate ATP released by surviving cells... Show more »

NJ Bio utilizes in vitro cell cytotoxicity assays to analyze the potency of toxins or antibody-drug conjugates (ADCs). Each ADC will be tested against a variety of cancer cell lines expressing the targeted surface antigens and normal cell lines to evaluate in vitro safety. These assays quantitate ATP released by surviving cells at the end of the experiment, which directly reflects cell viability. NJ Bio will work closely with you to design custom assays for your molecules.

NJ Bio offers classic 2D and novel 3D cytotoxicity assays, which provide comprehensive in vitro analysis of your ADC. The 3D assays utilize spheroids to mimic the physiological tumor microenvironment in comparison to the 2D assays where the cells adhere to the bottom of the well. Timelines for 2D assays are about five days and for 3D assays about ten days.

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Cell-Based Assays

Price on request

NJ Bio utilizes plate-based assays to characterize the ability of the compounds to promote or inhibit cell proliferation, establish the cytotoxicity of compounds by measuring live/dead cells. Assay optimization would include a time course of incubation and compound concentration analysis. Client will supply proteins for... Show more »

NJ Bio utilizes plate-based assays to characterize the ability of the compounds to promote or inhibit cell proliferation, establish the cytotoxicity of compounds by measuring live/dead cells. Assay optimization would include a time course of incubation and compound concentration analysis. Client will supply proteins for analysis. 

Services include:

  • 2D and 3D cytotoxicity assays
  • ADCC (antibody-dependent cell-mediated cytotoxicity)
  • Immunoassays (by ELISA)
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Protein Manufacturing

Price on request

NJ Bio can produce research-grade recombinant proteins, both mammalian and bacterial. Our experts will promptly identify and evaluate the best expression conditions for your protein, rapid expression of functional protein or antibody. Our preparation includes FPLC and HPLC analysis, QC detection using SDS-PAGE and Western blot.... Show more »

NJ Bio can produce research-grade recombinant proteins, both mammalian and bacterial. Our experts will promptly identify and evaluate the best expression conditions for your protein, rapid expression of functional protein or antibody. Our preparation includes FPLC and HPLC analysis, QC detection using SDS-PAGE and Western blot. Other services, such as MS, are optional. We also provide services of expression and production of biosimilars in HEK293 and CHO cells.

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Antibody Manufacturing

Price on request

NJ Bio can produce research-grade recombinant proteins, both mammalian and bacterial. Our experts will promptly identify and evaluate the best expression conditions for your protein, rapid expression of functional protein or antibody. Our preparation includes FPLC and HPLC analysis, QC detection using SDS-PAGE and Western blot.... Show more »

NJ Bio can produce research-grade recombinant proteins, both mammalian and bacterial. Our experts will promptly identify and evaluate the best expression conditions for your protein, rapid expression of functional protein or antibody. Our preparation includes FPLC and HPLC analysis, QC detection using SDS-PAGE and Western blot. Other services, such as MS, are optional. We also provide service of expression and production of biosimilars in HEK293 and CHO cells.

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Protein Production

Price on request
Request a quote for more information about this service.

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Protein Purification

Price on request

Our state-of-the-art purifications lab is equipped with an army of analytical and preparative HPLC and FPLC instruments and columns, which allows us to handle the most difficult separations for small and large molecules, including antibodies and other proteins. In addition, our LC-MS and Q-TOF mass spectrometers and 500- and... Show more »

Our state-of-the-art purifications lab is equipped with an army of analytical and preparative HPLC and FPLC instruments and columns, which allows us to handle the most difficult separations for small and large molecules, including antibodies and other proteins. In addition, our LC-MS and Q-TOF mass spectrometers and 500- and 300-MHz NMR spectrometers give us the capability to offer our clients valuable and reliable analytical data and along with these services. We are continually adding additional instrumentation in order to provide a seamless, uninterrupted operation. Our Analytical capabilities include: - Analytical and preparatory HPLC method development - NMR analysis (300 MHz, 1H, 13C, 31P, 19F, multidimensional) - Size-exclusion/gel-filtration chromatography - LC-MS analysis - Chiral separations - Stability studies at variable temperature and humidity - Purity determinations by HPLC - Ion-exchange chromatography - Intact mass for protein and protein conjugates using mass spectrometer.

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Protein Characterization

Price on request
Request a quote for more information about this service.

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Biopharmaceutical Process Development

Price on request

NJ Bio offers process development services for small molecules and protein manufacturing. In addition to traditional batch chemistry, NJ Bio's flow chemists have ample experience designing multi-step custom flow chemistry routes to drug intermediates and APIs. They can help you design chemical reactions in continuous flow... Show more »

NJ Bio offers process development services for small molecules and protein manufacturing. In addition to traditional batch chemistry, NJ Bio's flow chemists have ample experience designing multi-step custom flow chemistry routes to drug intermediates and APIs. They can help you design chemical reactions in continuous flow rather than batch, which offers many advantages, including: improved safety, better process control, and better heat transfer. In flow, it is possible to perform highly exothermic reactions in a safe and efficient manner. Additionally, in collaboration with the flow chemistry experts at Amar Chemistry Pvt. Ltd., we are able to design customized equipment for all your flow chemistry challenges.

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Flow Chemistry

Price on request

NJ Bio offers process development services for small molecules and protein manufacturing. In addition to traditional batch chemistry, NJ Bio's flow chemists have ample experience designing multi-step custom flow chemistry routes to drug intermediates and APIs.

Our flow chemistry experts can help you design chemical... Show more »

NJ Bio offers process development services for small molecules and protein manufacturing. In addition to traditional batch chemistry, NJ Bio's flow chemists have ample experience designing multi-step custom flow chemistry routes to drug intermediates and APIs.

Our flow chemistry experts can help you design chemical reactions in continuous flow rather than batch, which offers many advantages including improved safety, better process control, and better heat transfer. In flow, it is possible to perform highly exothermic reactions in a safe and efficient manner.

NJ Bio provides its flow chemistry services in collaboration with Amar Chemistry Pvt. Ltd.

  • Flow chemistry process development
  • High-pressure chemistry process development
  • Medicinal chemistry
  • Impurities synthesis
  • Small scale API synthesis

In addition, in collaboration with the flow chemistry experts at Amar Equipments Pvt. Ltd., we are able to design customized equipment for all your flow chemistry challenges.

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Equipment Design

Price on request

Design of Flow Chemistry Equipment in collaboration with the flow chemistry experts at Amar Chemistry Pvt. Ltd.

Design of Flow Chemistry Equipment in collaboration with the flow chemistry experts at Amar Chemistry Pvt. Ltd.

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Bioconjugation/Chemical Crosslinking

Price on request

Antibody-drug conjugates (ADC) are comprised of an antibody to which is attached a cytotoxic agent through a linker. The type of linker chemistry used play significantly affects the potency, selectivity, and the pharmacokinetics of the resulting ADC product. NJ Bio can offer a variety of linkers tailored for specific proteins... Show more »

Antibody-drug conjugates (ADC) are comprised of an antibody to which is attached a cytotoxic agent through a linker. The type of linker chemistry used play significantly affects the potency, selectivity, and the pharmacokinetics of the resulting ADC product. NJ Bio can offer a variety of linkers tailored for specific proteins and targets to affect potency, selectivity, and pharmacokinetics of resultant ADCs. These linkers will be selected based on the type of protein, antibody and desired release mechanism for drug molecules keeping long term stability of the protein as one of the priorities.

Bioconjugation services include the following:

  • Design and synthesis of potent cytotoxic compounds, linkers, and payload-linker constructs.
  • Preparation and purification of bioconjugates from milligram- to gram-scale.
  • Modification of carbohydrates, polysaccharides, and glycoconjugates.
  • Preparation of fluorescent probes.

Conjugation methods employed at NJ Bio include:

  • Cysteine conjugation
  • Lysine conjugation
  • Conjugation to engineered cysteines and non-natural amino acids
  • Enzymatic conjugation
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NJ

Nareshumar Jain

Managing Director

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