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

BioSolve FAQs

1 Who will find this tool invaluable?

Process development, Industrialization, operations and procurement personnel as well as suppliers to the industry wanting to demonstrate the specific performance of their technology. BioSolve will provide invaluable insight and business analysis for all these groups in their everyday activities.

2 How does BioSolve work?

BioSolve is an Excel-based bioprocess model based on industry standard engineering design principles which provides comprehensive analysis of operating cost drivers.

3 What information does the model provide?

BioSolve provides detailed calculations of cost of goods, total installed capital, utility sizing, facility throughput, bill of materials, and waste generation. All calculations are visible and traceable.

4 How long does it take to set up a new process?

With BioSolve you can set up a new process in a matter of minutes, either by modifying one of the standard template processes provided with the model or building a new process sequence.

5 Can I add my own unique unit operations?

Yes. We recognise that there are a wide variety of different bioprocess unit operations and it is easy to set up a new type of unit operation in BioSolve.

6 Can I compare stainless steel and single-use technologies for the same process?

Yes, BioSolve is configured to interchange single-use and stainless steel technologies based on rules you set such as size limitations and the applications where single-use technologies are used.

7 Where does the data in the model come from?

7.1 Cost Information:

  • Material Costs
  • List pricing from suppliers
  • Consumable Costs
  • Data is averaged out from specific suppliers
  • All cost data can be replaced with vendor specific information
  • Vendor pricing can be compared at the CoG level
  • Capital Costs
  • Derived from capital projects

Cost data will be reviewed and updated annually

7.2 Process data:

  • All process information from public domain sources with references available
  • Buffer recipes standard sets are supplied and can be extended as required
  • Unit operations: a standard library is supplied
  • Calculations are visible and can be changed
  • New Unit operations added in

8 Annual data updates

Cost information updated

Functional technology updates

9 Licensing and full support network for BioSolve

BioSolve is supplied on an end-user license basis. The license entitles the end-user to annual updating of cost information, additional , functionality upgrades and E-mail and phone support from the BioSolve Product Manager.

10 Specific questions from clients

Bags/Vessels Question: Is there any way to specify the use of single-use containers for volumes greater than existing vessels currently available in their facility?
Answer: No, the model determines the size of bags/vessels depending on the SS/disposable options and the solution volumes.
Cleaning Question: Is the cleaning regime specific to equipment and does the model includes line cleaning?
Answer: No, the model calculates the amount of cleaning materials based on average usage values. The simulation tool is more appropriate for such application.
Comment Question: Can users add comments to the cost data tables or process sequences?
Answer: Not at the moment as the non-user input cells are locked but it would be easy to add a comments column. This would improve the usability of the model.
Consumables Question: The ability to specify cycle limit for other types of filter e.g. sterile liquid filters, chromo guard filters.
Answer: This feature is currently not available but will be added to the list of enhancements for BioSolve.
Consumables Question: Are the use of bags accounted in the cost model?
Answer: Yes, the model tracks the amount of bags and vessels usage (“Facility Plan” worksheet) depending on the level of disposables implemented in the process. In addition, the water requirements and raw materials are tabulated.
Consumables Question: Can the user add another piece of consumable to the process?
Answer: The model currently only allows one piece of consumable per unit operation. We can customise the worksheet to cater for two pieces of consumables.
Cost Question: Where does the cost data come from?
Answer: The cost data is based on historical sources which are benchmarked using a number of biotech projects. The validity of the cost model has been verified by the presentation slides on our work with DSM.
Cost Question: What is the Adj Cost column?
Answer: The model will convert all cost data specified in the “Cost Data” worksheet to the desired currency specified in the “Parameters” worksheet.
Cost Question: There is a concern about the scaling for bioreactor cost. The base 450L bioreactor cost might not be accurate to scale larger bioreactor sizes.
Answer: We can modify the cost calculation rule for bioreactors by allowing users to enter costs for different bioreactors and to also have a scale factor for bioreactor size not specified in the “Cost Data” worksheet.
Database Question: Specification of huge amount of cost data in the “Cost Data” worksheet by their cost estimator.
Answer: The cost model has the ability to import data from external source.
Database Question: How easy would it be to specify cost data for other regions e.g. Asia into the model? The capital build and labour is normally cheaper in Asia countries.
Answer: This could be achieved by importing data from an external source into the model.
Equipment Question: Is the equipment list used to calculate required floor space (by area classification)?
Answer: Not currently. This feature is already on the list of possible future developments.
Equipment Question: How easy would it be to define new equipment for a new unit operation type?
Answer: This can be achieved by going to the process worksheet and adding in the equipment from the list of equipment items currently available in the model.
Equipment Question: How is the capital investment calculated?
Answer: The total equipment purchase cost is determined. The other capital factors e.g. pipework, installation are calculated based on benchmarked percentages of the total equipment purchase cost. There is an application note on capital estimation methodology available to BioSolve users upon request
General Question: Will the formulae in the cost model be transparent to the users?
Answer: Yes, all the formulae in the cost model will be unhidden i.e. the user is able to trace how each output value is derived.
General Question: How flexible is the cost model?
Answer: All calculations in BioSolve are visible and traceable. It allows the users to configure processes easily with its add-on functions in Excel.
Labour Question: Does the model have the ability to include regional labour rates.
Answer: This feature is on the list of enhancements. The user can also save a different workbook for each region and then compare the results from the workbooks.
Materials Question: Can raw materials (particularly solids) be used directly in the process sequence? The specific application includes PEG addition for a PEGylation step (or PEG for precipitation).
Answer: This is not currently possible in BioSolve but may be a feature that BPS need to add. It can be done by naming a solution “PEG” and setting the concentration to 1kg/L but then the “solution” would be associated with a prep/hold vessel which is incorrect.
Materials Question: Does the raw material costs include the discount for buying in bulk quantities?
Answer: The costs are currently listed as catalogue prices. We can customise a % factor to account for buying in bulk quantities.
NPV Question: Will NPV analysis be included in cost model?
Answer: This will be included in the proposal for xCellerex.
Process Question: Does the library of processes contain perfusion unit operation?
Answer: The unit operation is currently not in the cost model. However, we can customise the operation into the model.
Process Question: Does the list of processes contain microbial unit operations?
Answer: Yes, the typical unit operations for microbial process are captured in the model.
Reporting Question: Can a pre-formatted report be generated by the model?
Answer: Not directly, although the scenario/sensitivity/facility plan/details worksheets have been formatted as report tables/charts which are ready to be pasted into a Word document. This feature will add to the list of future developments.
Sensitivity/Scenario Question: Does the model allow the user to compare and analyse different scenarios?
Answer: Yes, the “Sensitivity” and “Scenario” worksheets would enable the user to specify different input parameters and carry out analyses for different sets of input parameters.
Sensitivity/Scenario Question: Would it be possible to change the parameter studied in the “Sensitivity” worksheet?
Answer: It is not currently possible to change the parameters. If there is a specific parameter that the user wants to evaluate, BPS can do the customisation for the client.
Solution Question: Does the model include the ability to indicate the solution preparation basis using a per week basis e.g. concentrated NaOH in the process is normally prepared on that basis?
Answer: This option is not currently available in the cost model. This requirement can be added and will be on the list of possible enhancements.
Solution Question: Is the user able to change the CF of solutions?
Answer: Yes, this can be easily done in the “Solution” worksheet.
Solution Question: Can the preparation of solution concentrates be applied only to some solutions, not all?
Answer: The “Make up concentrated buffers” parameter in the Dashboard applies for all the buffer solutions. To apply this only to some solutions, it can be achieved by specifying the CF factor as 1.
Utility Question: Would it be possible to adjust the parameters for utility sizing?
Answer: The utility sizing is currently based on the bottleneck of the process (in “Utility Sizing” worksheet) but can be easily changed to a user-input parameter.
Waste Question: Does the model have the ability to separate different types of waste streams with their costs.
Answer: No, the model currently treats all water waste with the same costs.