Please respond to our requirements within the QIMR Berghofer invitation to Offer Document

Question:
Dear Paul,

I hope this message finds you in good health.



We are pleased to have received the invitation to participate in Tender Number 2025-137. However, we would like to seek clarification regarding one aspect of the tender documentation.



Specifically, the document outlines that for Equipment 3, the Particle Size Analyser must meet the technical and functional requirements of High-resolution Dynamic Light Scattering (DLS) for measuring particle size and PDI. We would like to inquire whether this specification is a mandatory requirement or if you would consider alternative methodologies or technologies that can effectively measure particle size, concentration, and zeta potential.



We greatly appreciate your attention to this matter and look forward to your prompt response.



Thank you for your time and consideration.

Kind Regards,

Leyla

Answered on 01/Oct/2025 03:10 PM:


Hi Leyla,

Thank you for your enquiry.

We would be open to other technologies, if your equipment provides benefits over and above the requested specifications please ensure they are clearly outlined in your response.

Kind regards

Paul Bensley

Question:
Dear Paul,

I hope this message finds you well.

I am writing on behalf of my company regarding the tender above. Due to staff shortage (legal team and Product manager) being away unwell, we kindly request an extension of the submission deadline.

We believe that an extension of 7 days will enable us to provide a more comprehensive and competitive proposal, ensuring the highest quality of submission in line with your requirements.

We greatly appreciate your consideration of this request and look forward to your positive response.

Thank you for your understanding.

Kind Regards,

Leyla

Answered on 15/Oct/2025 01:40 PM:


Dear Leyla

Confirming we will provide an extension and update the closing date shortly.

Kind regards

Paul Bensley

Question:
I have some questions about this tender response document. Some sections seem inappropriately identified and include some information or requirements that do not make sense for the products being requested.

Under section 3.3 -Functional, performance and technical requirements, there are two main sub-sections:

(1) 3.3.1 Equipment 1&2 scope - Microfluidic Production Equipment , and

(2) 3.3.2 Equipment 3 Scope - Particle Size Analyser

The confusing part is that under 3.3.2, there are further sub-sections labelled "3.3.1. Standards" and "3.3.2. Regulatory Requirements".

The section on "standards" clearly relates to the scope of requirements for the Particle Sizer, but the numbering of both of these sub-sections make it difficult to reference specific requirements for questions.

Further to this, the sub-section on "Regulatory Requirements for LNP Equipment" seem out of place. I realise you are planning to use the Microfluidic production equipment to process LNP material (among other things), however it doesn't make sense to have LNP regulatory requirements as part of the scope for a particle sizer. The DLS system can measure physical properties of LNP's (size, zetapotential, etc..) but do not have any control over them.

Can you please clarify the naming of the above mention sub-sections and also why the section on LNP Equipment - Regulatory Requirements has been included ??

Answered on 10/Oct/2025 11:54 AM:


Hi Bryn

Thank you for your enquiry.

The evaluation is primarily based around the functional capability of the equipment, where you feel the standards referred to are not aligned to the equipment, please just reference the requirement is not applicable.

Kind regards

Paul Bensley

Question:
I have a question about some wording in this tender document.

Section 3.3.2 Equipment 3 Scope - Particle Size Analyser, under "Specifications - Technical and Functional Requirements", mentions the following:

- On-board calibration standards for size and zetapotential.

Can you clarify what you mean by "On-board" ??

Do you mean we simply need to be able to provide standards for PV/OQ testing, or do you need these standards need to be permanently housed on the particle sizer (not possible as standards tend to need to be stored under specific conditions!).

Also, can you please confirm:

- Is full IQ/OQ (Installation Qualification / Operational Qulaification) testing plus 21DFR Part 11 compliant software features mandatory requirement, or should we list these as an option ??. We can offer IQ/OQ testing/reporting and 21CFR Part 11 software features, but they come at an additional cost.

Answered on 10/Oct/2025 12:45 PM:


Good afternoon Bryn,

Please see responses below and my apologies for the confusion this specification doesn't look to be clear,

1. Section 3.3.2 Equipment 3 Scope - Particle Size Analyser, under "Specifications - Technical and Functional Requirements", mentions the following:

- On-board calibration standards for size and zetapotential.

Can you clarify what you mean by "On-board" ??

On-board calibration = standards for size and zeta potential

This means the instrument includes built-in reference standards that allow it to self-calibrate for:

• Size: Ensures accurate measurement of particle diameter (critical for LNPs, which typically range from 50–150 nm).

• Zeta potential: Measures the surface charge of particles, which affects stability and delivery efficiency of LNPs.

Please specify if this is not available.

2. Is full IQ/OQ (Installation Qualification / Operational Qualification) testing plus 21DFR Part 11 compliant software features mandatory requirement, or should we list these as an option ??. We can offer IQ/OQ testing/reporting and 21CFR Part 11 software features, but they come at an additional cost.

Confirming this is not specified as a mandatory requirement but is one we are querying, please include the capability and associated cost.

Kind regards

Paul Bensley