Process Development

Process Development
Product Description

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
Process Optimization
  • Condition screenings
  • Modification work-up & isolation process
  • Short-path distillation, column purification
Process Characterization
  • Impurity profile controls (purge/fate)
  • Characterize of Critical parameters (IND enabling)
  • Safety assessment, PGI impurity controls
Scale-Up Demonstration
  • Demonstrate the process on kilo scale
Reaction Engineering
  • Isolation and crystallization studies such as solvent screening and selection and solubility study
  • Impurity profile controlling such as impurity structure elucidation and impurity purge/fate
Enabling Technologies
Flow Chemistry
  • Special knowledge
  • Diverse reaction types
Carbohydrate Chemistry
  • Complex structure & sensitive molecules
  • Mono-saccharide synthesis experience
  • Isolation & purification techniques
Peptide Chemistry
  • Unnatural amino acids synthesis
  • Assembling strategy for cost & quality controls
  • Kilo scale synthesis up to 5-6 amino acid

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

More Products from BioDuro-Sundia

  • Drug Product Manufacturing

    Product Drug Product Manufacturing

    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)
  • Drug Substance

    Product Drug Substance

    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.  Fully integrated CMC services boasts a proven track record of over 100 clients. With over 20 IND & Generic DMF Filings, our team has deep experience in complex Sugar Chemistry & heterocyclic compound manufacturing.
    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)
    • Clean room for API production
    • Non-GMP pilot plant with 20 reactors from 300L – 5000L
    • Chromatography column/Separation System: DAC 150 & DAC 300
  • Formulation Development

    Product Formulation Development

    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.

    Pre-formulation & Discovery Support
    • Solubility, stability, compatibility, logP testing
    • Solid form screening & selection
    • Physicochemical profiling, drug ability assessment
    Formulation & Process Development
    • Process development based on physicochemical and physical properties of drug candidates
    • Storage and shipping conditions assessment of drug candidates
    • Technology transfer of formulation and manufacturing process to clinical manufacturing sites
    • CMC document preparation for IND/NDA/ANDA submission
    Filing Document Preparation
    • CMC document preparation and regulatory support
    • NMPA/FDA/EMA/TFDA dossier filling support
    Pre-formulation Development
    • pH/Aqueous Solubility
    • Solid state characterization
    • Intrinsic Properties Profiling & Dissolution
    • Polymorph screening
    • Salt screening
    • Co-crystal Screening
    • Crystallization Process
    SOLUBILITY ENHANCEMENT
    • Amorphous Solid Dispersion Development
    • Micronization
    • Nano-suspensions
    • SEDDS/SMEDDS
    • Evaluation at Lead Selection / Early Tox stage
    TASTE MASKING STRATEGIES
    • Reduce drug/taste bud interaction utilizing API-excipient Complexation strategies
    • Improve taste profiles of Orally Dispersible Tablets (ODT) by suspension & multiple/dual emulsion technologies
    • Protect against salivary pH response by application of stimuli-responsive coatings
    • Functionally coat your drug using Reverse Enteric Polymers
    HIGH POTENT FORMULATIONS
    Pediatric Dosage Deliver
  • Analytical Development

    Product Analytical Development

    BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services.

    Drug Substance
    cGMP Compliant Method Development & Validation
    • Starting materials
    • Intermediates
    • APIs
    • Qualification of reference standards
    API Characterization
    • Physical properties
    • Impurities identification
    • Structure elucidation & confirmation
    • Chemical characterization
    API Testing & Release

    Drug Substance specification support

    Analytical support for Formulation Development

    Stability Management & Testing (according to ICH/FDA/CFDA guidelines)
    • Stability indicating method validation & transfer
    • Preparation & Approval of stability protocol
    • Sample management
    • Sample testing
    • Data & trend analysis & preparation
    • analytical training, documentation & internal audit
    Stability Conditions include 
    • 20°C
    • 5°C
    • 25°C/60%RH
    • 30°C/65%RH
    • 30°C/60%RH
    • 40°C/75%RH
    • 50°C
    • Photostability
    Drug Product
    Method Evaluation Development & Optimization
    Method Transfer & Validation

    Drug Product specification & Support

    Stability Studies
    • Siemens APOGEE Monitoring System
    • Full generator backup
    • Drug product, drug substance, placebo
    • Testing Capabilities: XRPD; Dissolution; Karl Fisher
    Drug Product Testing & Release
    • Assay/impurities testing & method validation
    • Dissolution testing and method validation
    • Blend/content uniformity testing & method validation
    • Cleaning verification/validation
    • Protocol design
    • Long term stability testing
    • In-use stability testing
    • Accelerated stability testing
    • Forced degradation studiesTemperature cycling
    • Storage conditions: 25ºC/60% RH; 30ºC/65% RH; 40ºC/75% RH; 2-8ºC; -20ºC
    • Siemens APOGEE Monitoring System
    • Full generator backup
    • Drug product, drug substance, placebo
    • Testing Capabilities: XRPD; Dissolution; Karl Fisher

BioDuro-Sundia resources

  • Brochure Drug Product - Development & Manufacturing

    BioDuro-Sundia provides clinical development and commercial manufacturing of drug product—specializing in oral solid dosage forms and poorly soluble APIs. Our drug product services platform combines comprehensive pre-formulation assessment with advanced formulation technologies and robust GMP manufacturing capability.
  • Brochure Drug Substance - Development & Manufacturing

    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

    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.  
  • Brochure Formulation - Solution Engine 2.0

    BioDuro-Sundia’s Solubility Enhancement service is the fastest & most effective path to clinical formulation. We combine computer modeling, in-vitro screening & in-vivo PK to deliver optimal Amorphous Solid Dispersion prototypes. With 50-100mg of API & 8-10 weeks, we provide reliable prototypes to use in Phase I formulation & dosage development.
  • Brochure Analytical Development

    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

    Bioavailability enhancement for poorly soluble compounds
  • Brochure Drug Discovery - Chemistry

    BioDuro-Sundia offers Discovery Chemistry services provide small molecule design and synthesis to guide your drug discovery program through hit generation, SAR, lead optimization and candidate selection. We leverage decades of cutting edge expertise in medicinal, synthetic, and computational chemistry.
  • Brochure Drug Discovery - Biology

    BioDuro-Sundia’s Discovery Biology team has extensive experience in assay development and compound screening using biochemical and cell-based phenotypic functional assays for all major classes of drug targets, including: enzymes, GPCRs, epigenetics, PROTACs and beyond.
  • Brochure Drug Discovery - DMPK

    BioDuro-Sundia's Drug Metabolism and Pharmacokinetic (DMPK) services provide high quality in vitro and in vivo studies to help predict therapeutic outcomes and advance programs toward the clinic. We integrate with our early formulation development team to prepare for the clinic and maximize likelihood of successful development.
  • 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. 
  • Video Webinar - Protein Degraders

    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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