Buffer Preparation

Industry game changer in removing bottlenecks in manufacture.

Lack of standardization

During raw material transfer for buffer preparation, open processing requires a separate buffer prep area in the facility. Current buffer stock prep takes a significant amount of lead time and planning, which could be reduced by an automated solution with digital controls. There is a lack of standardization in buffer supply design. Stock solution selection (concentration & stock type) is not optimized to maximize the benefit of buffer stock blending. No guidance exists on how to best optimize (balance between minimizing volume of solutions vs standardizing concentrations used). The material handling approach is manual and labor intensive, with poor ergonomics and limited dust control

Biomanufacturers and suppliers collaborate

The collaborative approach of biomanufacturers and suppliers exploring the current state of the buffer preparation process with the goal of moving toward a lights-out (automated) closed system approach.

Q – Improved consistent, quality stock solutions that have a long shelf life to account for shipping/storage
$ – Reduction in non-value-adding activities, across the industry and supply base
$ – Facility footprint – more efficient use of high-cost areas within a facility (e.g., reduction in clean space area used)
S – Faster/adoption for BSB model
T – reduce facility bottlenecks

Buffer Preparation deliverables

DeliverableDateDetailsDownload

Evaluation of the design, development, and performance of a mass-flow based, open-source buffer manufacturing system

13 February, 2023Link

Bills of materials

24 August, 2022
192.79 KB
118 downloads

System P&ID

24 August, 2022
3.81 MB
130 downloads

I/O list

24 August, 2022
151.00 KB
85 downloads

Functional Specification

24 August, 2022
1.96 MB
110 downloads

Test Protocol FAT

24 August, 2022
15.94 MB
102 downloads

Executed SAT

24 August, 2022
3.79 MB
91 downloads

Automation

24 August, 2022
26.63 MB
125 downloads

White paper addendum to the NIIMBL-BioPhorum buffer stock blending system – a more advanced concept for buffer manufacturing

18 August, 2022
4.28 MB
177 downloads

BPI Europe May 2022 BSB presentation

31 May, 2022
2.23 MB
599 downloads

NIIMBL-BioPhorum BSB System – Buffer preparation of the future – presentation notes

15 October, 2021
2.45 MB
652 downloads

NIIMBL-BioPhorum Buffer Stock Blending System – Presentation notes

14 October, 2021
1.04 MB
705 downloads

IChemE global awards 2021 NIIMBL-BioPhorum Buffer Stock Blending System presentation

13 October, 2021
1.65 MB
62 downloads

ISPE virtual seminar NIIMBL-BioPhorum Buffer Stock Blending System presentation

13 October, 2021
1.46 MB
1223 downloads

Buffer Stock Blending (BSB) System: Published papers describing the project, drivers, concept and economic model

29 November, 2019
9.20 MB
439 downloads

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Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

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