Clinical Trial Manufacturing

News CPHI Milan 2024: Excerpts from the Exhibitors

After another successful year of bringing the pharmaceutical community together at CPHI Milan in October, hear direct from the exhibitors on why the event is so important for them and the industry as a whole.

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.

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 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.

News Quotient Sciences Completes Million Dollar Pharmacy Expansion at Miami Clinic

Miami, FL/June 22, 2020 - Quotient Sciences, a global pharmaceutical development, clinical and commercial manufacturing organization, announced today the completion of a $1 million dollar pharmacy and laboratory expansion at their Miami, FL clinical pharmacology facility.

The expanded pharmacy capabilities offer customers a quick and cost-effective way to start clinical testing, without the need for extensive CMC investment or API consumption at this early stage of development.

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.

News Quotient Sciences and CytoAgents Accelerate Potential Treatment for COVID-19 Cytokine Storm

Collaboration Expedites Human Clinical Trials for COVID-19 Drug Candidate. A collaboration to accelerate the development of a lead COVID-19 drug candidate into human clinical trials was announced today [April 28, 2020] by Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, and CytoAgents, Inc. a privately help biotechnology company focused on the development of pharmaceutical products for treatment of infectious diseases.

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.

News ANA Therapeutics and Quotient Sciences Announce Partnership to Manufacture Niclosamide Drug Candidate as a Potential Treatment for COVID-19 Collaboration

ANA Therapeutics, a Silicon Valley-based biotech startup, and Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, today announced a partnership to support the manufacturing of ANA Therapeutics’ drug candidate, ANA001 (niclosamide capsules), which they are developing as a potential treatment for COVID-19.

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.

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.

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.

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