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Biowaived Laboratory Now Operational

Biowaived Ltd. is officially open for business with the announcement that our laboratory in Sandwich, UK, is operational and prepared to assist clients with their dissolution and biopharmaceutics workflows.

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Biowaived Ltd. is officially open for business with the announcement that our laboratory in Sandwich, UK, is operational and prepared to assist clients with their dissolution and biopharmaceutics workflows. Our team of experienced analysts, now equipped with an inventory of qualified laboratory instruments, is prepared to fulfil client requirements with an unwavering dedication to quality of service. We offer a comprehensive range of testing and analytical services, giving clients confidence in their biopharmaceutics risk management, dissolution strategy, and formulation performance. We can help de-risk drug product performance ahead of clinical studies, support biowaiver applications by designing and delivering the required dissolution and solubility work packages and much more. Continue reading to learn more about the in vitro services we can offer.

 

API Properties

Assessment of a drug product performance starts with understanding the physicochemical properties of the active compound. Knowledge of the compound should be implemented in the design of the formulation and considered when designing in vitro test methods. With our new laboratory set up, we are offering a range of solubilty testing services including pH profiling, ICH M9 solubility studies for BCS-based biowaivers, solubility in biorelevant media, solubility in drug product vehicles, and solubility of amorphous materials. We also offer API physicochemical profiling such as pKa, LogP, Ksp, stability, bile partitioning and intrinsic dissolution rate (IDR).

 

Dissolution

Our dissolution capabilities extend to USPI (Basket), II (Paddle), III (Reciprocating Cylinder), and IV (Flow-Through Cell) apparatus for use with a range of different dosage forms and methodologies designed to assess in vitro product performance and support drug product development. In addition to standard or compendial dissolution tests we offer biorelevant dissolution studies to provide in vitro data which factors in the critical dissolution attributes affecting drug product performance in vivo enabling correlations to be made between them. If you need assistance with dissolution, our team has extensive experience with analytical method development and validation. With access to HPLC, UPLC, and online-UV technologies, we can design and validate your methods with ultra-fast run times for quick data generation and processing.

 

Supersaturation & Precipitation

Precipitation in vivo can pose a significant biopharmaceutical risk for basic and acidic compounds. From precipitation of an acidic compound administered as a liquid in the gastric environment to precipitation of basic API upon transition from gastric to intestinal environment, these processes can jeopardize drug product performance and lead to low bioavailability. Several techniques are available in the Biowaived laboratory for the assessment of supersaturation and precipitation. We possess the instrumentation and expertise to adapt dissolution methods to more closely mimic critical in vivo attributes. Two-stage dissolution transfer, biphasic dissolution methodologies and an artificial stomach duodenum (ASD) enable the assessment of supersaturation and precipitation under biorelevant conditions.

 

PBBM/PBPK & Dissolution Modelling

The in vitro data generated in laboratory must be interpreted and contextualised to aid biopharmaceutical risk assessment. In silico methods are helpful in supporting analytical method development and forecasting drug product performance based on experimental data. We are using Siemens gPROMS Formulated Products as part of dissolution workflows and to optimise dissolution conditions during method development. PBPK modelling is also possible using a range of simulated in vivo conditions, assisting with risk reduction and formulation selection.

 

Equipment List

  • Agilent 708-DS Dissolution Bath, 850-DS Sampling Station, Online Cary60 UV-Vis Spectrophotometer.
  • Erweka DFZ720 Dissolution System, FRL804 Fraction Collector
  • Varian Bio Dis Benchtop Dissolution System.
  • Pion Rainbow R2D Dynamic Dissolution Monitor
  • Physio-grad Bicarbonate Controller
  • Sotax DT50 Disintegration Tester
  • Aritificial Stomach & Duodenum (ASD)
  • Agilent HPLC Systems (1290 Infinity and 1290 Infinity 2)

 

We will be acquiring and qualifying further analytical equipment soon – follow us to keep up to date with our progress!

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Biowaived Laboratory Now Operational

September 17, 2024

Biowaived Ltd. is officially open for business with the announcement

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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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