info@njbiopharmaceuticals.com

675 US Highway 1, Suite B129, North Brunswick, NJ 08902

Protoxins for ADC

NJ Biopharmaceuticals developing protoxins for ADC. For more detail, Please visit our booth at World ADC London, March 2-4, 2019 or contact us at info@njbiopharmaceuticals.com.

CORE AND NICHE SERVICES

The following is a listing of our core and niche chemistry and biology services

  1. Protein- and antibody-drug conjugates
  2. Linker chemistry
  3. PEGylation
  4. Synthesis of toxins and cytotoxic drug molecules
  5. Medicinal chemistry for biopharmaceuticals
  6. Custom synthesis of small molecules
  7. Cell-based functional assays including cytotoxicity assays
  8. Cell line development for recombinant protein manufacturing.
  9. Research-grade protein and antibody manufacturing
  10. Protein purification and characterization
  11. Process development for small molecules and protein manufacturing using novel technologies.
  12. Flow Chemistry Custom Synthesis
  13. Design of Flow Chemistry Equipment

Protein, Antibody-Drug Conjugates and Payloads

NJ Biopharmaceuticals also has a variety of highly potent warheads/payloads in stock for advancing its clients ADC programs. A selection of cleavable and non-cleavable linkers and spacer molecules is also available. The following is a list of several classes of payloads in the toolbox for preparing ADCs or PDCs:

  • PBD dimer analogs
  • Duocarmycin analogs
  • Auristatin analogs
  • Maytansine analogs
  • Additional payloads (details available on request)

Other Bioconjugation Services include:

In addition to the services mentioned, NJ Biopharmaceuticals also provides other bioconjugation services such as:

  • Design and synthesis of potent cytotoxic compounds and payloads with linkers.
  • Customized design and synthesis of linkers.
  • Preparation and purification of bioconjugates from milligram to gram scale.
  • Modification of carbohydrates, polysaccharides, and glycoconjugates
  • Preparation of fluorescent probes

Quick On-Demand Conjugation Services using Lysine and Cysteine conjugation:

This service will require the client to supply the monoclonal antibody to NJ Biopharmaceuticals.

Amounts needed:

  • 5- 20 mg of mAB for preparation of 3 -7 mg of ADC for preparation of 5-10 mg of ADC
  • Unused amounts of antibody will be returned to client.

Deliverables:

  • The Well characterized conjugated materials with typically, the DAR is expected to be in the range of 3 – 5 and ADCs will be supplied in the desired formulation buffer.

Bioconjugation Services and Payloads

Antibody-Drug Conjugates and Payloads: NJ Biopharmaceuticals also has a variety of highly potent warheads/payloads in stock for advancing its clients ADC programs. A selection of cleavable and non-cleavable linkers and spacer molecules is also available. The following is a list of several classes of payloads in the toolbox for preparing ADCs or PDCs:

  • PBD dimer analogs
  • Duocarmycin analogs
  • Auristatin analogs
  • Maytansine analogs
  • Additional payloads (details available on request)

Other Bioconjugation Services include:

In addition to the services mentioned, NJ Biopharmaceuticals also provides other bioconjugation services such as:

  • Design and synthesis of potent cytotoxic compounds and payloads with linkers.
  • Customized design and synthesis of linkers.
  • Preparation and purification of bioconjugates from milligram to gram scale.
  • Modification of carbohydrates, polysaccharides, and glycoconjugates
  • Preparation of fluorescent probes

Quick On-Demand Conjugation Services using Lysine and Cysteine conjugation:

This service will require the client to supply the monoclonal antibody to NJ Biopharmaceuticals.

Amounts needed:

  • 5- 20 mg of mAB for preparation of 3 -7 mg of ADC for preparation of 5-10 mg of ADC
  • Unused amounts of antibody will be returned to client.

Deliverables:

  • The Well characterized conjugated materials with typically, the DAR is expected to be in the range of 3 – 5 and ADCs will be supplied in the desired formulation buffer.

Linker Chemistry

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 Biopharmaceuticals 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.

PEGylation

NJ Biopharmaceuticals 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

Custom Synthesis of small molecules

NJ Biopharmaceuticals’ 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:

  • Antibody-drug conjugates (ADCs)
  • Bioconjugate chemistry
  • Linker Chemistry
  • Carbohydrate chemistry (Including glucuronides)
  • Catalytic hydrogenation
  • Chiral synthesis and separations
  • General organic and small molecules synthesis.
  • Macrolides
  • Metabolites/ Impurities
  • Organometallic chemistry
  • Suzuki, Stille, Buchwald-Hartwig and other coupling reactions
  • Oxidations
  • Peptide/amino acid synthesis
  • Polycyclic aromatic hydrocarbons
  • Photochemistry
  • Pressure reactions.
  • Stable isotopes including deuterium, 13C, 15N
  • Steroids
  • Sulfonylations
  • Toxic/potent compounds
  • Ugi reactions
  • Wittig reactions

Medicinal Chemistry

NJ Biopharmaceuticals can provide services for any stage of the drug development process to advance a client’s drug discovery effort, from target identification through scale-up. Specifically, our services include:

  • Target identification
  • Lead generation
  • Lead optimization
  • Scale-up

The advantages of using NJ Biopharmaceuticals for your medicinal chemistry needs include:

  • Combination of experience and modern tools to deliver clinical candidates
  • Rapid and efficient deployment to enable “first-to-file”
  • Seamless progression from lead generation
  • Expertise in difficult protein-protein interaction inhibitors

Process Development and Flow Chemistry

NJ Biopharmaceuticals offers process development services for small molecules and protein manufacturing. In addition to traditional batch chemistry, NJ Biopharmaceuticals’ 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 Equipments Pvt. Ltd., we are able to design customized equipment for all your flow chemistry challenges.

Purification Services

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 300MHz NMR spectrometer 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.

Cell Based Functional Assay including Cytotoxicity Assays

NJ Biopharmaceuticals will use 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. Functional assays include binding assays.

Cell line Development for Recombinant Protein Manufacturing

We will establish a stable mammalian cell line for protein and antibody production, normally a time and cost consuming process. We possess extensive experience in cell culture and construct preparation to ensure success of the project. Transient transfection will be used ensure selection of a stable clone.

Research Grade Protein and Antibody Manufacturing

NJ Biopharmaceuticals can support the production of research-grade recombinant proteins, 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

Molecular Biology

We provide molecular biology services, including the preparation of expression plasmids for the production of both mammalian and bacterial recombinant proteins. Professional codon optimization will ensure the highest expression levels. According to the client’s specific requirements, tagged or tag-free protein service will be available for bacterial expression.

Service Model

SERVICE MODELS

Depending on the nature of the project, NJ Biopharmaceuticals offers its clients the following contract options:

  • Fee-For-Service:
    Client pays weekly fee for chemist plus cost of material and chemicals
  • Fixed Bid/Quote:
    Payment due on delivery only; labor and chemical costs included
  • FTE (Full-time equivalent) basis:
    Client pays fixed monthly fee per chemist; general materials included; both short-term and long -term contracts possible
  • Milestone based service:
    Clients pay NJ Biopharmaceuticals when certain milestones are achieved

OUR STATE OF THE ART FACILITY AND EQUIPMENT

NJ Biopharmaceuticals currently occupies more than 4000 sq. ft. of newly renovated, energy-efficient, and environmentally friendly state-of-the art laboratory space, with room for expansion, at CCIT – a project of the New Jersey Economic Development Authority in North Brunswick, NJ. Our suite of laboratories consists of…Read More

OUR PEOPLE AND CULTURE

We have highly talented and experienced laboratory chemists and biologists with a tremendous passion for chemistry and biology resulting in unique solutions to client programs. Furthermore, our corporate culture is collaborative, communicative, and adaptable. Most importantly, our scientists strive to deliver quality services in a cost-effective and timely manner.

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