Biowaived Biopharmaceutics Experts
Delivering biopharmaceutics and dissolution strategies for pharmaceutical and biotechnology companies to support drug product development.
Evaluate Biopharmaceutical Risks
Assess Drug Product Performance
Develop Dissolution Workflow
Understand the performance of your drug product
A strategic and systematic approach to drug product development can conserve resources by reducing risks linked to product performance in patients. Our expertise can assist in selecting the suitable dissolution test that focuses on the key performance attributes.
Optimising Formulation Bioperformance
Biopharmaceutics Risk Management
Expert analysis and advice combined with experimental services to understand drug product performance and de-risk a project across development milestones and clinical studies.
Dissolution Strategy And Workflow
Analytical and biorelevant dissolution studies to support drug product development and deliver a complete dissolution data package in readiness for regulatory submissions.
Dissolution Guided Drug Product Design
Access expert advice to understand the critical dissolution attributes which define formulation performance and ensure that performance in patients is at the core of your drug product design strategy.
Services
Begin your journey to confidently understand the critical performance attributes for your formulation’s performance – we offer assistance ranging from a simple solubility profile through to biopredictive dissolution testing.
Access Biowaived’s expert services for consultancy and laboratory based experimental support for biopharmaceutical risk assessment, optimising formulation performance for relative bioavailability & bioequivalence studies and our product performance-led approach to dissolution method development.
Consultancy
Our consultancy services include biopharmaceutics risk management, Physiologically Based Biopharmaceutics Modelling, dissolution design, method development strategy so that drug product performance is understood and bioequivalence risks are minimised. Partner with us to navigate complex challenges and accelerate your project across all phases of clinical development.
Dissolution
We specialise in dissolution method development and designing dissolution studies to understand drug product performance. We offer dissolution work packages to support formulation changes throughout the drug product lifecycle and for regulatory submissions. Our services include fast HPLC assay method development to reduce resource demand and improve carbon footprint.
Biorelevant Dissolution
Our biorelevant dissolution services include dissolution testing in standard and complex biorelevant media including dissolution in bicarbonate based buffer conditions. Biorelevant dissolution studies are designed to consider the critical attributes affecting drug product performance in vivo including media composition, pH, mixing and gastrointestinal transit. We can modify dissolution conditions to reflect the relevant patient population including simulation of paediatric biorelevant conditions.
Solubility
We offer a range of solubility studies including pH solubility profiling, ICH M9 solubility studies for BCS-based biowaivers, solubility assessments in complex biorelevant media, evaluations of solubility in drug product vehicles, and analysis of amorphous material solubility. Our goal is to gain insights into the compound's behaviour and contextualize solubility data by considering physicochemical phenomena such as self-association and interactions with media components, ultimately delivering a thorough understanding of your drug's solubility and its effects on drug product dissolution.
Supersaturation & Precipitation
We offer two-stage dissolution transfer experimentation and/or the artificial stomach duodenum model to profile supersaturation and precipitation under physiologically relevant conditions. Understand how your formulation performs on gastric emptying and the risks associated with precipitation in the small intestine.
API Properties
Acquire comprehensive characterisation of your Active Pharmaceutical Ingredient (API) through our expert analysis of its physicochemical properties including pKa, LogP, and Ksp, as well as its pH-solubility profile, intrinsic solubility, stability in aqueous media, bile partitioning, and intrinsic dissolution rate. Physicochemical profiling will help you evaluate and address biopharmaceutical risks during drug product development.
BCS Biowaiver
We will help you prepare for BCS based Biowaiver applications by designing and delivering solubility and dissolution studies. We can work with a range of vendors to design the appropriate permeability experiment for your molecule from a basic screen to a full BCS biowaiver data package. A well designed dataset will help you prepare for a successful biowaiver application.
PBBM/PBPK & Dissolution Modelling
We offer predictive in vitro dissolution modelling using Siemens gPROMS Pharmaceutics either as part of a dissolution workflow, or as a separate service to aid optimisation of dissolution conditions. We also offer PBPK modelling services to support biopharmaceutical risk management and formulation selection.
Start The Conversation
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Discussion to understand your project
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Agree on a proposal to address the key risks
03
Deliver the data with expert interpretation and inform your go-forward strategy
We know the challenges successful medicines overcame
Designing your drug product to seamlessly transition through clinical development is a challenging task that needs a clear focus on biopharmaceutics and product performance throughout the development lifecycle. Here at Biowaived we can offer our collective experience from many years of industrial experience with projects spanning early preclinical development, FiH/PoC studies, late-phase clinical development, commercial registration and life-cycle management. The Biowaived team are an experienced group of Biopharmaceutics Experts who can provide expert guidance and experimental support to ensure your drug product design strategy is focused on performance in the people who matter – the patients!
- Real World Project Experience
- Biopharmaceutics Specialists
- Formulation, Analytical & Material Science Expertise
- Fully Equipped Laboratory With Modelling Capability
The Biowaived Team
Our team is comprised of experienced scientists in Biopharmaceutics, Formulation, Analytical and Materials Sciences.
Biopharmaceutics Blog
Don’t fail your Phase 1 study because of formulation
October 10, 2024
In this article, we discuss formulation considerations when preparing for
Frequently Asked Questions
Biopharmaceutics is the study of the factors influencing the bioavailability of a drug. Biopharmaceutics allows formulation scientists understand how the drug product that they are developing will perform when dosed to patients and to optimise formulation to achieve the desired performance.
Simple dissolution tests are not able to replicate the complex dynamic conditions present in the human GI tract. Prediction of clinical performance of a drug product requires comprehensive understanding of drug material properties, drug product behaviour, and human physiology. Only by combining this knowledge with appropriately designed dissolution tests it is possible to predict the in vivo performance of a drug product.
Biorelevant dissolution attempts to replicate conditions relevant to the physiological environment in which the drug product will dissolve. For example, biorelevant dissolution media simulates some of the complexity of intestinal fluids (presence of bile salts and phospholipids).
A well designed dissolution workflow in combination with PBPK modelling can help understand and address biopharmaceutical risks and to inform drug product design. However, the dissolution methodology must take into consideration the potential failure modes associated with the drug material and drug product characteristics as well as the interactions between physiology and the drug product.
