NJ Bio Inc., Princeton

New Jersey, United States
NJ-Bio-Inc,-Princeton

NJ Bio Inc., Princeton

New Jersey, United States

The NJ Bio, Inc., Princeton facility houses multiple specialized laboratories, including those for bioconjugation, linker–payload and high-potency API (HPAPI) synthesis, protein and antibody production, functional assays, process development, and analytical method development. It also includes suites for GMP manufacturing with accompanying analytical labs. The site is equipped with advanced instrumentation and state-of-the-art laboratories, to support development of complex modalities of all types such as bioconjugates. The facility’s integrated resources ensure seamless support across the entire drug development process, accelerating programs from discovery to the clinic.

NJ Bio Inc., Princeton

New Jersey, United States

Capabilities

  • Bioconjugation: R&D and GMP manufacturing (Phase I & II)
  • Antibody-drug conjugates (ADCs): R&D to GMP manufacturing (Phase I & II)
  • Antibody- Oligonucleotide Conjugates (AOCs): R&D to GMP manufacturing (Phase I & II)
  • Linker-Payloads & Small molecules: Synthesis from R&D to GMP manufacturing (Phase I & II)
  • Oligonucleotides & Analogs: Custom synthesis and purification of oligonucleotides, NTPs, nucleosides & capping analogs
  • mRNA synthesis
  • Targeted protein degraders
  • Radiopharmaceuticals: Ligand synthesis and conjugates
  • Characterization & Testing: Analytical, bioanalytical, bioassay and NMR (Center of Excellence)

Production Capacity

Research & Development

  • Bioconjugation (R&D): mg to 500g
  • Linker-payload synthesis: 10mg to 200g
  • Synthesis & purification of customized Oligonucleotides, NTPs, Nucleosides & Capping analogs: 10mg to 60g
  • Small molecules (General API & HPAPI): mg to kg scale
  • mRNA scalability: 1µg (Small scale) to 20g (Large scale)
  • Antibody Production: 50mL to 4L
Process Development
  • Payload-Linker Development: Scale-up to 50 - 500g (Process / High Potent Suite)
  • Bioconjugation Development: Scale-up to 2 - 50L (Purification / TFF Capabilities)
Manufacturing
  • Bioconjugation & Biologics Manufacturing: Up to 50L Reactor size
  • Chemical Technologies Manufacturing - HPAPI/Cytotoxic: 200 – 500g; API: 500 – 1000g
  • cGMP and non-GMP small molecule/payload-linker manufacturing (scale: 50 – 500g)
  • Small scale (2 – 50L) suite to manufacture mRNA, antibody conjugates, and other biopharmaceutical products to support Tox and Phase I

Equipment & Utilities

Mass spectrometry:

  • QTof system
  • UPLC w/ Tof MS detectors
  • SQDs
HPLC
  • HPLC with UV detector
  • HPLC with autosampler and fraction collector
  • UPLC systems
Purification
  • Combiflash EZ Prep flash/ HPLC purification system
  • Combiflash Rf flash systems
  • FPLC & SFC systems
  • Other chromatography systems
NMR
  • 800-MHz NMR spectrometer with cryoprobe
  • 700-MHz NMR spectrometer with cryoprobe
  • 300 – 500MHz NMR spectrometers with multinuclear probes
Bioconjugation / Bioassays
  • Bioreactors
  • TFF systems
  • Flow cytometer
  • Live-cell analysis system
  • Automated cell counting system
  • Automated liquid handling system
  • Multiplexing plate reader
  • Biolayer interferometry system
  • Bacterial Endotoxin testing system
  • Oligonucleotide synthesizer
  • Automated peptide synthesizer
  • Imager
Chemistry & Process:
  • Microwave reactor
  • Photoreactor with 450W UV Lamp
  • Inert atmosphere glovebox
  • Negative pressure isolators
  • 5L Jacketed reactor with temperature control system
  • Lyophilizers
  • Multiple fume hoods
Analytical / QC
  • HPLC/ UPLC
  • GC
  • MS
  • cIEF
  • Differential scanning calorimeter
  • TOC analyzer
  • Capillary electrophoresis systems
  • Microplate readers
Utilities:
  • HVAC
  • Purified water systems
  • Compressed gas
  • Vacuum system
  • Electrical power & backups
  • Waste handling systems
(* Multiple units of instruments available across labs for parallel operations and backup capacity.)

Capabilities

Multi-scale cGMP intermediate & API manufacturing

Production Capacity

Total Reactor Volume: 406 KL

Annual Output Capacity: XXX MT

Block-wise Capacity:
Block Capacity Key Features
Block A 60 KL Intermediate Manufacturing
Block B 166 KL API Manufacturing
Block C 110 KL High-Potency Handling
Block D 10.5 KL Pilot Scale Production
Total Number of Reactors: 89

Equipment & Utilities

Reactor Types
  • Glass-lined
  • Stainless Steel

From [XX L] to [YY KL]

  • Centrifuges
  • Dryers (ANFDs, Tray Dryers, RCVDs)
  • Distillation Units
  • Micronizers
  • HVAC Systems
  • Boilers with backup power
  • Chillers and Cooling Towers
  • Purified Water and WFI Systems
  • Nitrogen Generation Plant
  • Reactor Types: Glass-lined, Stainless Steel
  • Reactor Range: From [XX L] to [YY KL]
  • Key Equipment:
    • Centrifuges
    • Dryers (ANFDs, Tray Dryers, RCVDs)
    • Distillation Units
    • Micronizers
  • Utilities Infrastructure:
    • HVAC Systems
    • Boilers with backup power
    • Chillers and Cooling Towers
    • Purified Water and WFI Systems
    • Nitrogen Generation Plant

History

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Experience

Our great team of more than 1400 software experts.

Quick Support

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Leadership Team

John Smith
CEO
Emma London
Co-Founder
Jessica Brown
Managing Director
Christine Eve
Designer

Sustainability

ESG

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Quality & Compliance

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We deal With The Aspects Of Professional IT Services

About us

Engitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,

Experience

Our great team of more than 1400 software experts.

Quick Support

We’ll help you test bold new ideas while sharing your.

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We deal With The Aspects Of Professional IT Services

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