Late Stage Development - Integrated Programs

Late Stage Development - Integrated Programs
Product Description

.Accelerating products through to commercial manufacture - Speed the journey from proof-of-concept to commercial launch. The journey from proof-of-concept to commercial launch can be complex. Speed is critical but it shouldn’t come at the expense of product quality. Creating patient-centric formulations and scaling up from pilot-scale to commercial manufacturing, we help clients turn promising molecules into successful drug products.

QUOTIENT SCIENCES LIMITED

  • GB
  • 2017
    On CPHI since
  • 500 - 999
    Employees
Company types
Academic/Research
Consultancy
Contract Service
Manufacturer/Innovator
Specifications
  • Supplied from
    United Kingdom; United States

QUOTIENT SCIENCES LIMITED

  • GB
  • 2017
    On CPHI since
  • 500 - 999
    Employees
Company types
Academic/Research
Consultancy
Contract Service
Manufacturer/Innovator

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QUOTIENT SCIENCES LIMITED resources (21)

  • News Quotient Sciences acquires UK-based CDMO Arcinova

    With over 40 years of experience and 160 employees, Arcinova provides drug substance, drug product and bioanalysis services to over 200 pharma and biotech customers worldwide
  • Technical Data Formulation Development at Quotient

    Quotient Sciences has almost 30 years of experience developing a breadth of pharmaceutical formulations across a range of indications. Our innovative approach to formulation development integrates drug product development with clinical evaluation, combined with our experience with over 1,000 molecules at all stages of drug development. 
  • Technical Data Clinical Pharmacology at Quotient

    When you are looking for a partner who is dedicated to Phase I trials and early development,rely on Quotient Sciences. 

    We accelerate your molecule from first-in-human to proof-of-concept,helping you make critical decisions earlier. 
    Whatever clinical pharmacology study you require, you can expect a fully integrated program from study design to data reporting.
  • Technical Data Global Formulation & Manufacturing Capabilities

    With over 30 years’ experience, Quotient Sciences provides full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.
  • Technical Data Clinical Trial Manufacturing at Quotient

    Understanding that early phase clinical testing is a pivotal milestone in the development of your drug product, Quotient offers a clinical trial manufacturing, testing and certification service designed to meet your individual requirements. 

    Our innovative method of building integrated GMP and GCP programs provides you with a streamlined, flexible approach to drug product supply that reflects your clinical study design and timeline. 


    We understand the time and cost pressures you face during early phase evaluation and work with you to ensure a rapid, seamless path from development to clinical trial supply.
  • Technical Data Commercial Manufacturing at Quotient

    Pharmaceutical commercial manufacturing - Quotient Sciences is a global player in commercial drug product manufacture of small molecule products for niche therapies including oncology and orphan drugs. 
    Our commercial manufacturing facility located in Philadelphia is designed to handle your high-potency compounds.
  • Technical Data Pediatric Development at Quotient

    Pediatric formulation and product development
    The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. 

    Quotient Sciences has extensive knowledge and capabilities that enable us to provide you with a unique integrated pediatric development solution.

  • Technical Data Taste Masking at Quotient

    Many drug substances are extremely bitter or have other aversive attributes,which can make developing palatable drug products extremely challenging.This is a common problem seen in medicines spanning all therapeutic areas,from antibiotics and painkillers to antihistamines and decongestants. The careful design and development of formulated oral drug products is key to ensuring patient acceptability and compliance for achieving the desired clinical outcomes.
  • Technical Data 505(b)(2) Product Development at Quotient

    Are you developing a new dosage form for an existing drug? 

    Do you need to explore a different route of administration?

    Quotient has significant experience in 505(b)(2)product development and can support you in efficiently turning your innovative ideas into successful products.Over the past several years, the FDA’s 505(b)(2)regulatory pathway has enabled the approval of a variety of differentiated dosage forms for existing molecules
  • Technical Data Translational Pharmaceutics - a Quotient Innovation

    Translational Pharmaceutics® accelerates drug development by integrating formulation development, real-time manufacturing and clinical testing. The platform is unique to Quotient Sciences and has been used over the last decade by global pharmaceutical and biotech companies across over 400 drug programs.
  • Technical Data PBPK Modelling and Simulation at Quotient

    Quotient is a leading expert in the application of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) science to drug development. 

    Using GastroPlus™ we advise our clients on the potential in vivo performance of drugs and formulations to inform product and clinical development strategies. 


    Whether working in a consultancy relationship or as part of an integrated program of work, our PBPK expertise is underpinned by our unique and extensive experience in pharmaceutics, biopharmaceutics, DMPK and clinical research.
  • Technical Data Pre-formulation & Material Sciences at Quotient

    Providing expertise to support pre-formulation development

    Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
  • Technical Data Compounding and GMP Manufacturing for Product Supply at Quotient

    Quotient Sciences provides integrated pharmacy compounding, formulation, GMP manufacturing and clinical testing solutions to help clients achieve their proof-of-concept (POC) milestone quickly, saving them precious development time and money.  

    Begin your First-in-Human (FIH) Phase I testing with a fit-for-purpose, simple pharmacy preparation, and then seamlessly transition to a scalable, solid oral GMP drug product for Phase II trials, all within one organization.
  • Technical Data Inhaled Product Development at Quotient

    With more than 30 years’ experience, Quotient is a leader in the development, manufacture and assessment of inhalation products, helping clients to accelerate molecules from first-in-human through to proof-of-concept. 

    Our integrated capabilities and vast knowledge encompasses pre-formulation sciences, formulation development, device evaluation, clinical trial manufacturing and the clinical assessment of a variety of inhaled formats for nasal and pulmonary delivery.
  • Technical Data High Potency Handling at Quotient

    High Potency Drug Development & Manufacturing

    Highly potent active pharmaceutical ingredients (HPAPIs) are becoming increasingly common in drug development pipelines, especially in the oncology sector, as researchers search for therapies with greater selectivity and pharmacological activity. However, HPAPIs present additional CMC challenges due to the containment requirements to protect both the operators and manufacturing facilities. Their production processes may also require greater precision and control due to the very small quantities of drug present in the final dosage form.
  • Technical Data Human ADME Studies at Quotient

    Whatever your requirements, Quotient Sciences can support you in the generation of clinical metabolism data for your drug development program and for NDA, MAA and global regulatory filings.
  • Technical Data First-in-human to Proof-of-Concept at Quotient

    Quotient Sciences’ Translational Pharmaceutics® approach enables First-in-Human studies by re-engineering the transition of your drug molecule into clinical development and shortening the timeline to Proof-of-Concept.

    How? Quotient’s Translational Pharmaceutics® platform integrates formulation development, real-time adaptive GMP manufacturing and clinical testing so that drug product manufacture occurs immediately prior to dosing.Each manufacture of drug product is therefore conducted in response to emerging clinical data. This approach delivers significant benefits to the development team.
  • Technical Data Spray Drying at Quotient

    Overcoming poor drug solubility and bioavailability challenges

    Drug solubility has a significant impact on bioavailability. 70% of new chemical entities (NCEs) suffer from low aqueous solubility that can result in failure during clinical testing due to poor bioavailability. Selecting an appropriate drug formulation is imperative to the success of the program.
  • Technical Data Project Management at Quotient

    Project Management at Quotient – A True Partnership
    Quotient is an innovative drug development and manufacturing partner supporting clients from candidate selection to commercial launch. With expertise in end-to-end Project Management and integrated project teams, we make drug development easier for our customers and dramatically reduce the time and cost of getting new medicines to patients.
  • Technical Data Formulation Strategies for Poorly Soluble Molecules at Quotient

    As the number of poorly soluble compounds continues to increase in the industry development pipeline, conventional formulation strategies may not be sufficient to achieve acceptable levels of solubility in the gastrointestinal tract and hence absorption into the systemic circulation. Scientists will need to utilize advanced formulation technologies to maximize oral bioavailability.
  • Video John McDermott, Quotient Sciences, discusses the unique benefits of Translational Pharmaceutics

    John McDermott, Executive Director, Drug Development Solutions - Quotient Sciences discusses Translational Pharmaceutics at CPHI Worldwide, and how a recent Tufts study has proven the significant savings and financial benefits for drug developers who use Translational Pharmaceutics.