Sunesis selects Quotient to support ADME programme

Published: 13-Feb-2015 Featured companies: Quotient Sciences
Regulatory

A clinical mass balance/ADME trial for vosaroxin, a candidate therapeutic for acute myelogenous leukemia, has been initiated


Translational pharmaceutics company Quotient Clinical and Sunesis Pharmaceuticals have announced the initiation of a clinical mass balance/ADME trial for vosaroxin — a candidate therapeutic for acute myelogenous leukemia (AML).

For this programme, Quotient will employ its real-time adaptive manufacturing approach to supply 14C radiolabelled vosaroxin to a specialist oncology clinic in the Netherlands.

The intravenous product will be manufactured on a per patient basis and supplied to the clinic ready for dosing within two weeks of patient notification. This approach offers the most efficient use of the radiolabelled drug and tailors drug product manufacturing to ongoing patient recruitment.

Mark Egerton, CEO of Quotient Clinical, commented: ‘Vosaroxin represents an exciting potential therapeutic option for AML patients, and we are delighted to be supporting Sunesis on its clinical mass balance/ADME programme. Our real-time adaptive manufacturing approach offers increased flexibility and enables customisation of drug product supply to the requirements of individual patients and trials.’

Gene Jamieson, Vice President of Technical Operations at Sunesis Pharmaceuticals, added: ‘Working with Quotient Clinical will help to accelerate the clinical mass balance/ADME programme for this promising therapeutic. The company's real-time manufacturing capabilities will ensure efficient, cost-effective and timely delivery of radiolabelled vosaroxin to the clinic, allowing faster treatment of patients as they are enrolled into the study.’

Featured companies

Quotient Sciences is a drug development and manufacturing accelerator providing integrated services across the entire development pathway for small-molecule and peptide drug...
  • Companies:
  • Sunesis Pharmaceuticals
See more

You may also like

Regulatory

Quotient passes FDA test of bioanalytical facility

Read more
Conducted to audit three bioequivalence studies for three different insulin analogues,

Trending Articles

  1. Overcoming CMC challenges in cell and gene therapy: part II Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  2. Overcoming CMC challenges in cell and gene therapy: part I Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  3. Momentum in the US cannabidiol market gains retailers' attention Walmart and other big-name stores in talks with food and drinks makers in preparation for the day CBD-enriched products are allowed on the shelves
  4. Ametek Mocon achieves accreditation for analytical testing laboratory Ametek Mocon, provider of instruments and services for testing, measuring and analysing a variety of gases, has achieved ISO/IEC 17025 accreditation for its Minneapolis analytical testing laboratory
  5. Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena

Relevant companies

See more

Upcoming event

Cleanroom Conference UK

22–23 May 2024 | Exhibition | Birmingham, UK See all

You may also like

Regulatory

Quotient passes FDA test of bioanalytical facility

Conducted to audit three bioequivalence studies for three different insulin analogues,
Manufacturing

Quotient acquires formulation development specialist Co-Formulate

Acquisition reinforces and extends Quotient’s existing pharmaceutical development capabilities in solid, semi-solid and liquid formulations
Regulatory

Overcoming CMC challenges in cell and gene therapy: part II

Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
Regulatory

Overcoming CMC challenges in cell and gene therapy: part I

Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
Regulatory

AskBio receives FDA Fast Track Designation for congestive heart failure gene therapy programme

The fast-tracking allows the development and expedition of review processes for AB-1002, a gene therapy to promote production of a constituently active form of I-1c
Manufacturing

Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success

Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena
Regulatory

Isospec Analytics launches biomolecular analysis technology to identify unknown molecules

The novel technology optimises the identification process of unknown molecules compared to mass analysis
Subscribe now