Objectives

The primary objective of this tender is to procure the supply and delivery of custom-made, single-stranded oligonucleotides on an ad-hoc basis for a period of 12 months. The successful bidder will provide oligonucleotides manufactured according to specified technical standards, ensuring quality, compliance, and timely delivery to support ERWAT's operational needs.

Scope

The scope encompasses:

• Supply and delivery of custom-made, single-stranded DNA oligonucleotides in specified quantities and formats.
• Production of oligonucleotides using proprietary synthesis platforms, automated high-throughput DNA synthesizers, solid-phase synthesis, and phosphoramidite monomers.
• Ensuring synthesis follows a 4-step cycle: deblocking, coupling, capping, and oxidation.
• Provision of oligos in lyophilised form, with in-house production of key reagents, and in accordance with quality control standards (ESI-MS and UV spectrophotometry).
• Online ordering service with options for base sequence specification and product customization.
• Compliance with relevant certifications (ISO 9001, ISO 14001, ISO 13485) and distribution authorizations within South Africa.
• Adherence to delivery timelines, quality standards, and inclusion of all import, taxes, and delivery costs.

Technical Requirements

The technical specifications include:

• Production using proprietary, automated DNA synthesizers with solid-phase synthesis and phosphoramidite monomers.
• Synthesis cycle: deblocking, coupling, capping, oxidation.
• Deprotected, desalted, lyophilised oligonucleotides.
• In-house formulation and reagent production, with calibration and manufacturing of DNA synthesizers.
• Quality control via electrospray ionisation mass spectrometry (ESI-MS) and UV spectrophotometry for quantification.
• Demonstrated synthesis efficiency and product coupling efficiency.
• Provision of products in lyophilised form with online ordering capabilities.
• Certifications: ISO 9001, ISO 14001, ISO 13485, and distribution authorisation in South Africa.

Skills and Skills Requirements

The bidder must demonstrate:

• Expertise in automated DNA oligonucleotide synthesis using proprietary platforms.
• Capability to produce high-quality oligonucleotides with validated synthesis efficiency.
• Proficiency in quality control techniques such as electrospray ionisation mass spectrometry (ESI-MS) and UV spectrophotometry.
• Experience in formulating and desaling oligonucleotides in lyophilised form.
• Ability to operate and calibrate in-house DNA synthesizers.
• Provision of online ordering systems with customizable options.
• Certification and authorization to distribute oligonucleotides within South Africa.
• Capacity to handle import, taxes, and delivery logistics efficiently.