Drug Product Manufacturing

Drug Product Manufacturing
Product Description

BioDuro-Sundia's Drug Product manufacturing services support clinical and commercial scale GMP production for a comprehensive range of oral solid dosage forms, including: solid, liquid, and semi solid dosage forms. This includes fully-audited manufacturing facilities (FDA and other regulators) with exceptional track records.  Our manufacturing teams work closely with our formulation development teams to ensure optimal drug delivery from all dosage forms, especially poor solubility APIs.
Dosage forms

Tablets 

  • Intermediate Table Release
  • Coated Tablets
  • Matrix Tablets
Capsules
  • Blend in capsules
  • Tablets in capsules
  • Liquid in capsels
  • API in capsules
  • Pellets in capsules
Topicals
  • Intermediate Table Release
  • Coated Tablets
  • Matrix Tablets
Ophthalmic

Beads, Pellets, & Granules
  • Coated pellets/beads
  • Controlled release beads
Oral Liquids
  • Solutions
  • Suspensions
Injectables Solutions

Packaging
  • Tablets in bottles
  • Capsules in bottles
  • Liquid in bottles/vials
Formulation Technologies
  • Amorphous Solid Dispersions: Spray-drying; Hot-melt extrusion
  • Tablet Compression
  • Encapsulation
  • Milling
  • Wet granulation
  • Blending
  • Roller Compaction
  • Freund-Vector LDCS Pilot Hi-Coater
  • Fluid-bed drying
  • Dry granulation
  • Early Phase GMP Form Kilo Lab (outsource)

BioDuro-Sundia

  • US
  • 2018
    On CPhI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Contract Service

BioDuro-Sundia

  • US
  • 2018
    On CPhI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Contract Service

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    Facility Overview
    • Manufacturing facilities & storage – 20,000 ft2²
    • Capability of wastewater disposal: 50 tons/day
    • Utility: Saline water cooling, compressed air, soft water
    • 120 research fume hoods in Process Lab
    • Non GMP kilo scale lab: 17 reactors from 50 – 100L
    • cGMP kilo lab: 5 reactors from 100 – 200L
    • Temp reaction capability: 800C℃ – 2300C℃
    • Pressure reaction upto 1mPa (120 psi)
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    • Chromatography column/Separation System: DAC 150 & DAC 300
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    BioDuro-Sundia’s process development services support drug substance production,  providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts.
    Services Areas:


    Route Design & Evaluation
    • Design & evaluate potential synthetic routes
    • Material & production cost analysis of each route
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    • Condition screenings
    • Modification work-up & isolation process
    • Short-path distillation, column purification
    Process Characterization
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    • Characterize of Critical parameters (IND enabling)
    • Safety assessment, PGI impurity controls
    Scale-Up Demonstration
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    Reaction Engineering
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    • Impurity profile controlling such as impurity structure elucidation and impurity purge/fate
    Enabling Technologies
    Flow Chemistry
    • Special knowledge
    • Diverse reaction types
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    • Mono-saccharide synthesis experience
    • Isolation & purification techniques
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BioDuro-Sundia resources

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    BioDuro-Sundia’s Drug Substance manufacturing services support production of small molecule APIs, RSMs and intermediates--both GMP and non-GMP .  We provide a full range of production scale, supporting all stages of drug substance development through IND submission.
  • Brochure Drug Substance - Process Development

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    BioDuro’s analytical team is well-integrated into the formulation and manufacturing programs to facilitate and accelerate the development of the analytical methods and testing of prototypes, raw materials and drug products. Sharing knowledge of the formulation and the manufacturing process results in analytical data that is scientifically sound and project support that is well-coordinated and timely.

    Experienced and dedicated development and QC chemists at BioDuro are committed to the highest levels of technical quality and GMP compliance.
  • Brochure Drug Product - Commercial Capability

    BioDuro-Sundia's Drug Product manufacturing services support clinical and commercial scale GMP production for a comprehensive range of oral solid dosage forms, including: solid, liquid, and semi solid dosage forms. This includes fully-audited manufacturing facilities (FDA and other regulators) with exceptional track records.  Our manufacturing teams work closely with our formulation development teams to ensure optimal drug delivery from all dosage forms, especially poor solubility APIs.
  • Brochure Drug Product - Clinical Capability

    BioDuro-Sundia holds more than 25 years of experience formulating poor solubility and  poor permeability drugs for the clinical studies. Our comprehensive suite of advanced formulation technologies and extensive scientific know-how supports >95% of marketed dosage forms.  Our GMP manufacturing operations focus on quality, efficiency and reliability ensures timeliness for your clinical trial supply. 
  • Brochure Drug Product - Amorphous Dispersions

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  • Video Company Video - Integrated Drug Discovery, Development and Manufacturing at BioDuro-Sundia

    BioDuro-Sundia is your partner for accelerating drug discovery, development and manufacturing--from molecule to market. Find out more at http://www.bioduro-sundia.com. 
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    Since 2015 the field of targeted protein degradation has rapidly emerged, offering opportunities for novel pharmacological interventions in ways impossible to achieve with traditional small molecule inhibitors. This webinar focuses on cutting-edge drug discovery using protein degraders, such as PROTACS, in diverse therapeutic areas. Attendees can expect to learn about recent strategies toward development of orally bioavailable protein degrader drug candidates—PROTACs and beyond.

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