Case Studies
A Continuous Bioprocess Manufacturing Platform
A bespoke Britest facilitated study helped CellRev, a solutions provider in controlling cell-to-cell and cell-to-surface attachment, in improving process understanding for a breakthrough in continuous bioprocessing technology. With the support of a Britest facilitator, CellRev’s study team were able to turn their collective knowledge into working descriptive models, a prioritized scale-up risk assessment, and multiple follow-up actions for further concept development. This was an important element in shaping CellRev's R&D programme, and fed into inter-company technology transfer with Cellrev’s chosen development partner for a new continuous manufacturing platform.
Probing Deep Understanding of an LC-UV-MS Method for Characterising Oligonucleotides
When a multinational pharmaceutical manufacturer wanted to get to a deep understanding of a strategically important analytical method to inform improved training and method standardisation the Britest methodology was used to complement established methods of Analytical Risk Assessment. A tailored DuDES analysis identified opportunities to remove subjectivity from the method, leading to harmonisation across departments and external partners, identification of actions to improve training materials and the internal standardised method, and consequential benefits for in-country testing.
Setting Objectives to Commercialise an Innovation Project
Facing the challenge of needing to know whether to commit further to the commercialisation of an innovative process in the early stages when data is limited, the partners in the LevWave collaboration were able to benefit from Britest successfully piloting an understanding-based methodology for setting commercialisation objectives allowing key risks and knowledge gaps to be identified and addressed.
Addressing Loss of Yield and Increased Impurity Levels in Clinical Manufacture
Product manufacture in AZ’s Large Scale Lab encountered a significant negative trend in yield and increased impurity for a particular product. A three-hour Britest session identified 14 potential corrective actions covering chemistry, engineering and analysis. By systematic testing, the root cause (oxygen ingress) was identified. By improving vessel purging AZ were able to reduce impurity to 2% and increase the yield from 50% to 70%. Successful manufacture corresponded to $250K of cost deferred.
Efficient Analytical Validation Using Britest Visualisations As Protocols
Protocols for Liquid Chromatography method validations under GMP often require complex dilution schemes with many opportunities for errors in execution. This necessitates inefficient extra checks, and duplication of work (further consuming valuable API). Presenting the dilution schemes visually using a Britest ‘Rich-PrISM’ has made the dilution schemes far easier for analysts to follow. The result is substantially reduced lead time and resource consumption, and all protocols executed 'right first time'.
Decision Making for Investment in Innovation
Business decisions are frequently complex and, where innovation is concerned, uncertainty in the assessment of the alternatives on offer adds to the complexity. Britest can provide a structured decision making approach which enables decision makers to capture key business and technical information and the business benefits sought. This case study describes how we were able to help a speciality chemical manufacturer considering various investment options to enhance their production flexibility.
KUDOS - Sharing collective process insight
Right across the process industries manufacturers use similar unit operations and face similar challenges as they strive to optimise their performance. At the same time, collaborative research projects often struggle to disseminate fresh insights about process technologies widely and in ways that endure. Britest Knowledge and Understanding Domains (KUDOS) collate process understanding, generated through projects, in a form that allows process sector companies to learn about different process operations and challenges.
Mapping the Manufacturing Value Stream to Spot Improvement Opportunities
When the technical team responsible for a market-leading medicine within a high-profile global, science-led biopharmaceutical company wanted to establish where process improvement opportunities existed for the product line, they turned to a Britest study to summarise process inputs, outputs and key information. The study allowed the manufacturing value stream to be seen end-to-end in great detail for the first time ever, highlighting value gaps and the scale and location of improvement opportunities, and catalysed both "quick-win" actions, and a plan to deliver the pipeline of improvement projects identified.
Overcoming Analytical Sample Preparation Issues to Improve Method Reliability
Analytical scientists at AstraZeneca were able to rapidly and effectively identify and eliminate subtle procedural variations in a test method being used to make product quality decisions with significant cost implications for any batch wrongly rejected. Britest tools were used to visualise the sample preparation regime in detail, breaking it down to identify potential sources of variation, and prioritise these for further investigation in a factorial experimental design. Re-wording the test method restored the method to control, saving $10-50k per out of specification result prevented.
Improving Access to Organisational Knowledge: A Visual Understanding of a Key Unit Operation
A large company in the pharmaceuticals sector has been able to transform the availability and hence use of existing information and existing work on the commonly used isolation technique of pressure filtration. Britest Rich Pictures and Cartoons provided an elegant format to portray and summarise current information and understanding, and by digitising these into a dedicated internal site, AstraZeneca were able to produce an easy to use guide to pressure filtration development.
Optimising Plant Changeover / Cleaning Processes
A Britest methodology to support the optimisation of changeover/cleaning processes was used to help FUJIFILM Imaging Colorants address capacity constraints. Improvements to significantly time-consuming steps, and opportunities for improvements to existing CIP equipment were identified, along with a more ambitious opportunity to reduce the cleaning cycle time from 2-3 days to 12 hours through targeted use of a key cleaning solvent.
Increasing Production of a Speciality Chemical by 50% to meet demand
This case study describes how a Britest study enabled an internal cross-functional team at Robinson Brothers Limited to rapidly identify and implement process changes designed to improve efficiency and up time, making it possible to support extra sales of ~£1M p.a.
A Structured Approach to Whole Process Review
Read how Britest has enabled biotechnology pioneers Biogen to conduct a structured review of manufacturing operations with an end-to-end view of the entire manufacturing process in order to guarantee product quality and robustness.
Supporting Complex Decision Making in Route Selection
For complex, multiple step separations there are often many possible routes to the end product. This is exacerbated if several products are to be manufactured from a single feed-stream. Faced with this challenge, Johnson Matthey turned to Britest tools and methodologies to find the optimal process route for separation of platinum group metals.
Process Options - Balancing Development Risk and Commercial Opportunity
In process development several potentially viable options may be on the table, each with its own complicated risk - reward relationship. This case study from Johnson Matthey shows how a process development team used Britest to make progress in deciding between several process options with disparate project/developmental risks and potential commercial impact.without sacrificing appropriate rigour in their decision making process.
Gap Analysis at the Start of New Process Development
Britest facilitation of a process for open dialogue between manufacturers, equipment providers and key stakeholders provided the framework for dialogue needed for Johnson Matthey to engage in a collaborative research and development programme to develop an improvement approach to recycling Platinum Group Metals. Beneficial outcomes were minimisation of research risk, identification of uncertainty, and stakeholder buy-in.
Supporting scale-up in an innovative start-up business
Conductive Organics, is a University of Strathclyde spin-out company, working to produce the next generation of conductive organic materials for use in emerging technologies such as Organic Light Emitting Diodes (OLED's). A Britest study enabled Conductive Organics to address the challenge of scaling-up the synthesis of the key organic compound at the heart of their innovative formulations, and to gather underpinning information to support their emerging business plan.
Improving Food Operations Training
Stu Brew is Europe’s first student run microbrewery, helping students gain hands on experience at running a business, operating equipment and researching sustainability improvements for the brewing process. This case study describes how Britest tools have been used by Newcastle University to support operation of the microbrewery, and in particular to help train student operators to enhance process understanding.
Britest coordinating collaborations
Participation in strategic initiatives such as the EU H2020:SPIRE Public-Private-Partnership opens up powerful influencing routes and further opportunities, but it takes excellent project management skills to pull the complex elements of a collaborative project together into a coherent whole. This case study describes how Britest brought together a consortium of ten partners to successfully bid for and deliver a two-year project collating views from EU process industry sectors, public sector, academics and sustainability experts to positively influence future approaches to sustainability evaluation across the EU.
Troubleshooting Reaction Issues in Additives Manufacture
An example of how a Britest study enabled one of the world's leading formulators, manufacturers and marketers of fuel and lubricant additives to gain a fundamental understanding of the influence of raw material composition and process conditions on the properties of a free-radically produced polymer which wasn't always hitting the mark. Having identified an issue in a critical raw material, Infineum were able to agree a new monomer specification with their supplier and save £350k a year.
Use of Britest to aid Communication and Problem Solving
Read how the use of the Britest tools and approach encouraged chemists and engineers in a large manufacturing organisation to address a problem in pressure filtration which had been dragging on for three years - saving the business £500K a year.
Decision Making for Equipment Selection
Equipment selection is an important activity for manufacturing companies, as wrong choices can be costly with respect to product quality, production time, production rate and resource allocation. With support from Britest, FUJIFILM Imaging Colorants Limited were able to work with an academic specialist in the field of decision support to develop decision criteria, and evaluate four equipment options using a range of decision making approaches in order to reach an informed decision about selecting a piece of mixing equipment.
Rapid optimisation of a new process in Pharmaceutical API manufacture
Read how Britest successfully provided the structured approach needed by a process development centre within a large multi-national pharmaceutical business to optimise a new process in a very short time period.
Collaboration, customer focus and value creation - delivering JM's core values
Johnson Matthey Emission Control Technologies develops and manufactures coated catalyst systems for automotive applications. This case study exemplifies a typical study where Britest tools act as a focus to bring together different disciplines and business locations in collaborative programmes allowing JM to deliver its core values.
Problem Solving through Process Understanding - Particle Coating for Controlled Release
Read how a Britest problem solving study rapidly enabled a major pharmaceutical manufacturer to get a controlled release drug capsules product back to target release profile after transferring the process to new manufacturing equipment.
Britest Methodology Implementation in Specialist Additive Manufacturing and Formulation
This case study summarises how Infineum and Britest together developed an approach to effectively embed Britest in the organisation and the value gained.
Britest Improvement Study to Increase Throughput by 50%
This case study describes the elements of a Britest throughput improvement study carried out by a custom synthesis manufacturer to meet an identified customer need to increase process throughput by at least 50% within three years, which was successfully delivered by halving batch times.
Technology Transfer Made Easy in a Contract Manufacturing Organisation
Read how a Britest facilitator was able to help a contract manufacturing organisation who did not know the Britest tools identify a common language for effective technology transfer.
Challenging ideas on an established manufacturing process
How do you reduce costs and drive value when you've been operating a process for 25 years? This Britest study with a fine chemical company did exactly that by challenging established idea of what was and wasn't optimal in the process chemistry to speed up and simplify the reaction route.
Customer and Supplier Working Together as a Team
An illustration of how two Britest members in a supplier/customer relationship were able to use Britest as a framework for working together to solve a problem with a chemical intermediate product.
Britest in Drug Product Development
A large pharmaceutical manufacturing Britest member had identified processing issues associated with a micronisation step during late stage development with several new drug candidates intended for inhalation. A multi-disciplinary, cross-site team was put together which used Britest tools to identify key material attributes, equipment and process parameters impacting upon the micronisation unit operation. With the root causes identified the team was able to define a generic workflow and guidance for successful micronisation in the future.