Biopharm Services

News from BPS


Feb 2012: New Technology Grant

1 FEB 2011: Biopharm Services has been awarded a UK Technology Strategy Board grant to develop our software bioprocess database application to support rapid bioprocess development and technology transfer to manufacturing. Extending the functionality of the BioSolve platform to recipe management and facility fit.


New Newsletter published

New Newsletter published October 2011. Gives details of the exciting changes happening with the BioSolve Suite.


Annual Bioprocess Simulation prize

Biopharm Service's Annual Bioprocess Simulation prize was awarded in November 2011 to a team of undergraduate students at UCL's Department of Biochemical Engineering for their work on "Application of BioSolve computer simulation tool for investigating the process economics of antibody production". The BioSolve modelling tool was used to evaluate the economics of a process to produce an IgG antibody for treating arthritis and to understand impact of scale-up to and for process optimisation. This demonstrates the value of BioSolve to help students within the teaching programmes at UCL to understand the impact of process and technology choices.
Download the UCL BioSolve poster


Past President of the IChemE joins the Biopharm Team

Bioprocess specialist Stephen Vranch joins Biopharm Services. Since 1968 Stephen has held senior positions in Project and Process Engineering, Fermentation and Process Development and in Production of Diagnostics and Biological Therapeutic Pharmaceuticals, including licensed bulk product. Stephen was a former President of the IChemE. As our lead consultant, Stephen specialises on all aspects of CGMP regulatory compliance.


BioSolve

BioSolve used to generate data for GE lifecycle assessment of the entire monocloncal antibody production process: a comparison of multi-use and single-use processes. Upcoming webinar

Adoption of BioSolve Process in UCL Biochemical Engineering Courses

BioPharm Services is pleased to announce the adoption of BioSolve Process by the Biochemical Engineering Department of University College London (UCL). The cost modelling software has been used for both undergraduate and postgraduate courses including the MBI® programme (Modular Training for the Bioprocess Industries). MORE »



CLIENT FEEDBACK

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Biopharm Software Services

Promedior Inc Feedback

'BioSolve is an excellent tool for planning early stage process development alternatives.'

'BioSolve provides a quantitative edge when presenting proposed directions to investors.'

'BioSolve enables us to focus on potential process bottlenecks in terms of cost or throughput.'

Scott Willett, Director biopharmaceutical development, Promedior Inc

Dow Pharmaceuticals Feedback

'One hidden benefit of BioSolve is that it is comes populated with an enormous wealth of historical industry data and this allows us to benchmark Pfēnex Expression Technology's performance more accurately than we would be able to do with internal data alone.

'This enables us to better articulate the key Cost of Goods advantages realized by our clients'

Patrick Lucy, Global Business Development Leader, Pfēnex Inc, Dow Pharmaceuticals

Xcellerex Inc Feedback

'BioSolve has been a very useful tool for demonstrating to our prospective customers the benefit of disposables and the FlexFactory platform.'

'One hidden benefit of BioSolve is that it is comes populated with an enormous wealth of historical industry data and this allows us to benchmark more accurately than we would be able to do with internal data alone.'

'We use BioSolve with prospective customers to plug their specific numbers into the model. All the data and assumptions are clearly presented for review and discussion. The Excel format and preset templates allows BioSolve to be reconfigured quickly and easily at a high level or manipulated at a very detailed level, depending upon the needs and sophistication of the user.'

Geoff Hodge, Managing Director - Technology, Xcellerex Inc.

Sanofi Pasteur Feedback

'Validating investment scenarios is a key part of developing our business strategy and is used to set priorities. With BioSolve, what used to take months now can be evaluated in a day! We were amazed recently when on a particular case we were able to generate comparable and coherent results in a day that did take us months manually to prepare. Not only does this save a lot of time it helps us to carry out sensitivity and 'what if' scenario analyses with BioSolve, this supports better informed decision making.'

Jean-Marc Guillaume, Head of cell culture and virology, Sanofi Pasteur vaccines

Avecia Biologics Feedback

'BPS models provide Insight into the complexities of biotech plants, It helps to set Direction in projects and improvement programmes'

Bruce Williams Avecia Biologics

Millipore Feedback

'It is important for the customer to select the right mix of Mobius® single-use solutions to optimize their manufacturing process and maximize the return on investment. BioSolve, an industry wide popular modeling package allows the customers to map their process and develop cost of ownership models'.

Vikas Gupta, Group Product Manager, Advanced Manufacturing Solutions, Millipore corporation

BioSim FAQs

1. Who will find this tool invaluable?

Process development, industrialization, operations and procurement personnel. BioSim allows detailed analysis of real-life complex manufacturing scenarios providing insight into key areas where performance can be improved and assessment of short-term planning options for campaigns.

2. How does BioSim work?

The simulation toolset consists of two major components: a discrete event simulation model used to simulate activities in the facility, and a user configurable database used to hold the data required by the simulation. The model consists of a file and a number of software libraries that utilise a specialist, commercially available, simulation platform named “Extend”. The database is used to drive the model and contains all the required data on both the processes and the facility. The database is held in Microsoft Excel as sets of tables in a series of worksheets.

3. What is included in the simulation?

BioSim simulates the process steps in detail. The model also takes into account other factors such as: support, utilities, vessel availability, labour, scheduling, probability of success for the production of entire campaigns for multiple products where required. Multiple production suites and products can be modelled in one simulation model.

4. What information does BioSim provide?

The BPS Simulation toolset is a discrete event simulation package focused on the needs of the bioprocess industry. It is a tool that can be used to assess real-life processes that are too complex to analyse using spreadsheets or flowcharts including:

  • Identifying potential bottlenecks and analysing how to remove them
  • Evaluating the impact of new products and process revisions prior to their introduction to a bioprocess facility
  • Validating conceptual and detailed designs
  • Optimising the use of capital
  • Defining equipment sizes
  • Formulating operating procedures
  • Defining and validating expansion plans
  • Building and proving complex production schedules
  • Validating shift patterns
  • Providing detailed planning for future operations
  • Analysing different technology options
  • Reproducing and resolving problems experienced on a plant
  • Determining absolute capacity for different facility designs, product mixes and operational scenarios

5. How long does it take to set up a new process for a product?

Once an Extend model has been configured new processes can be defined in the Excel model database. New processes can be created in seconds by copying an existing process that can then be subsequently modified. The model database can hold multiple process definitions. Once the database has been populated with required process information the new process can be imported into the Extend model and simulated.

6. Can I add my own unique unit operations?

Processes are defined in the Excel model database. Unit operations can be created and modified by the user as required.

7. How long does a model take to run?

Depending upon the complexity of the model a run can be completed within minutes. Longer simulation of production campaigns and multi-product facilities with significant constraints can take up to an hour.

8. Where does the data in the model come from?

The database will typically contain real information about your facility and processes. BPS can help to build this data set for you by carrying out a data gathering exercise. We also have a wealth of standard information which has been built up during our long experience in the industry. This data has been benchmarked against real facilities.

9. What are the outputs from the model?

The simulation model can generate considerable amounts of data. To aid insight into your process this data is arranged graphically in Gant charts and also in tables that contain process data and support data. Key outputs include:

  • Process results – Results associated with the main process equipment and operations. These include batch cycle time data, equipment utilisations, and information about delays accumulated by the process as the model runs.
  • Support results – Results associated with support equipment and operations. These include CIP, SIP, process solution, process utilities, and vessel allocation information recorded as the model runs.

The model output can also be exported to a simplified BioSolve cost module to enable the calculation of cost of goods driven by the detailed output of the simulation model.