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The Biowaived approach to reducing risk for formulation performance

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Evaluate Biopharmaceutical Risks

Assess Drug Product Performance

Develop Dissolution Workflow

Assisting small molecule biotech and pharma companies to understand the critical attributes for drug product performance and implement a strategy to reduce the risks associated with formulation design and pharmacokinetic performance in patients.

Stage 1: Profile

Profile the biopharmaceutics properties of your molecule and formulation.

  1. Physicochemical Profiling
  2. Biopharmaceutics Risk Assessment
  3. Gap Analysis

Stage 2: Inform

Evaluate in vitro and in silico methods to profile the performance of your molecule and formulation.

  1. Design in vitro strategy
  2. Develop a PBBM model
  3. Build a Biopharmaceutics Workflow

Stage 3: Translate

Drug Product Performance – From the lab to the patient.

  1. Identify critical material and/or process attributes
  2. Confirm formulation performance under clinically relevant conditions
  3. Translate formulation performance to the patient

Start The Conversation

01

Discussion to understand your project

02

Agree on a proposal to address the key risks

03

Deliver the data with expert interpretation and inform your go-forward strategy
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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.

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Aaron brings a solid foundation of analytical expertise from academia and industry to his position at Biowaived.

He earned his master’s degree in biotechnology from the University of Kent in 2016. His professional career began at Eurofins Lancaster Laboratories, where he was responsible for assessing solid dosage form characteristics in support of formulation development.

Aaron later joined Pfizer Analytical Research and Development in Sandwich where he specialised in dissolution design and analytical method development. He had leading roles in implementing initiatives to enhance operational efficiency to reduce overall work-in-progress during formulation development and in supporting project teams with regulatory filings. In this role, he gained valuable experience of in vitro drug product performance in relation to pharmaceutical quality.

As Chief Compliance Officer, Aaron is dedicated to positioning Biowaived as a trustworthy entity in its field, ensuring that the organization not only meets regulatory standards but also builds a reputation for integrity and reliability in its operations.

Mike is set to become the Chief Technology Officer at Biowaived. He holds a degree in Chemical and Pharmaceutical Sciences from the University of Sunderland and is an RSC Chartered Chemist, bringing with him 28 years of experience from GSK and Pfizer, where he developed a keen interest in advanced analytical technologies.

During his early career, Mike spent 14 years in Research Formulation at Pfizer, where he not only assisted with pre-formulation and physicochemical profiling activities, but also led the execution of multiple fully integrated automation projects, encompassing kinetic, thermodynamic, and BCS solubility as well as Caco-2 absorption screens.

He subsequently joined Drug Product Design at Pfizer where he spent several years leading cross functional teams during the late-stage development of two novel parenteral projects.

Over the past decade, Mike has dedicated himself to the field of Materials Science at Pfizer, displaying an elevated level of technical expertise and a strong analytical approach to problem solving. This combination has empowered him to effectively lead multidisciplinary teams, both within the organisation and externally, in the investigation of intrinsic and extrinsic particulates identified during drug product development.

Kieran brings over a decade of experience in pharmaceutical analysis to his role as Chief Operating Officer at Biowaived.

He holds a Master’s degree in Chemistry from the University of Surrey and began his career at the British Pharmacopeia Commission Laboratory, where he developed his analytical skillset, testing a vast array of products and developing pharmaceutical monographs.

Following this, Kieran joined Pfizer and gained considerable experience in pharmaceutical development from early product design stages through to regulatory submission. Through a focused commitment to studying dissolution, he developed a deep understanding of drug product performance and the importance of dissolution testing; not only to ensure the quality of medicines but also to predict in vivo performance.

Kieran advocates for continuous improvement and adaptability, believing that focus on mentorship, collaboration and productivity can create a dynamic and responsive work environment. He enjoys new challenges and implementing strategies to streamline processes.

Inese joins Biowaived as the Chief Executive Officer, bringing with her experience from both academic and industrial settings.

During her Master’s and PhD studies in physical chemistry at the University of Latvia, she developed a strong fascination with molecular processes. This foundation has proven helpful in her subsequent work within the biopharmaceutics field, where understanding the physicochemical properties of drug compounds is crucial for drug product bioperformance.

Over the course of her career in the pharmaceutical industry, Inese has worked on modelling techniques that extract insights from experimental data, thereby facilitating drug product development. While at Pfizer’s Drug Product Development group, she worked on integrating the knowledge of material properties with in vitro study outcomes to forecast the performance of drug products. Inese aims to harness her passion for innovative solutions to position Biowaived as a trusted partner for pharmaceutical companies in need of biopharmaceutical expertise.

Dr Mark McAllister is a Pharmacy graduate from Queen’s University Belfast and has a pharmaceutics PhD from Aston University which focused on liposomal delivery to the lung for the treatment of cystic fibrosis infections. 

Mark has 30 years industrial development experience and has specialised in oral delivery systems and biopharmaceutics through roles with Hoechst-Roussel, GlaxoSmithKline and most recently as a Senior Director and Head of Global Biopharmaceutics, part of the Drug Product Design group at Pfizer in Sandwich, Kent. 

Mark was the Pfizer drug product lead for Lorlatinib, an accelerated small molecule treatment for NSCLC, commercialised as Lorviqua in the EU and Lorbrena in USA/Canada/Japan. He is a former chair of the Academy of Pharmaceutical Sciences and is currently a visiting lecturer at King’s College London. 

Mark co-led the IMI ‘OrBiTo’ biopharmaceutics project, an academic/industrial collaboration, focused on the development of the next generation of models to predict oral absorption and he currently participates in a number of pre-competitive research programmes including COLOTAN, AGePOP and InPharma Marie Skłodowska-Curie innovative training networks. 

Mark is a Fellow of the Royal Pharmaceutical Society and the Academy of Pharmaceutical Sciences. Mark is a co-author on more than 60 peer-reviewed publications and book chapter contributions, multiple patents and invited presentations and 50 poster presentations.

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