API Innovation Cluster (APIIC) Expression of Interest
The Council for Scientific and Industrial Research (CSIR) is inviting suitable candidates to express their interest in joining a national initiative known as the Active Pharmaceutical Ingredients Innovation Cluster (APIIC). This cluster is driven by the Department of Science, Technology and Innovation (DSTI) and the Technology Innovation Agency (TIA), with the CSIR serving as the host.
This call, titled "Process Development for the Production of APIs Using Modern Manufacturing Technologies – Translational Development Call," aims to address critical challenges in South Africa’s health system, including drug shortages, concerns over poor-quality medicine, and significant reliance on imported Active Pharmaceutical Ingredients (APIs). This reliance creates a security of supply risk and contributes to a significant trade deficit.
The APIIC's primary focus is driving the local manufacture of APIs in South Africa. The current Expression of Interest (EoI) seeks to align capabilities across various higher education institutions (HEIs), science councils, and commercial companies to establish a National Programme for the production of small-molecule APIs for human health using modern manufacturing technologies.
The Opportunity and Translational Support
The core goal of this EoI is to support researchers and institutions seeking to scale their proof-of-concept API production processes from Technology Readiness Level (TRL) 3 to TRL 6+. This involves demonstrating the synthesis of selected small molecule APIs at laboratory-pilot scale.
The APIIC is interested in processes that demonstrate synthetic improvements to enhance competitiveness, such as:
• New routes that reduce reaction steps or improve yields.
• The application of green process design, offering high "atom economy" and minimizing waste.
• Batch processes, continuous flow processes, biocatalytic processes, or hybrid systems.
Projects must address a clear market need for molecules on the South African essential medicines list whose patents have expired, or those in specific high demand across the African region.
Application Requirements and Deadlines
This is an open call for proposals from local researchers, universities, science councils, other public research organizations, and Enterprises registered with the Companies and Intellectual Property Commission (CIPC). Applicants must be South African citizens or permanent residence holders.
Applicants must use the specific APIIC proposal template which requires comprehensive details on the project, including:
• A Project Summary detailing progress achieved and translational development interest (TRL 3 to 6).
• Differentiating features of the proposed process compared to existing API production processes.
• Specific market need, potential market size, and route to market.
• Intellectual property status (ownership or licensing).
• Expected social and economic outcomes and impact.
The closing date for applications is 17:00 CAT (or SAST) on 31 October 2025.
Applications must be submitted via email to APIIC@csir.co.za.
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The DSTI/TIA/CSIR API Innovation Cluster (APIIC) Expression of Interest (EOI) is a call for translational development support, not a funding call.
1. Scope of Support
The EOI does not cover the following:
- Infrastructure: No funding for new or existing infrastructure requests.
- Operational Costs: Excludes salaries, rent, telephony, and similar expenses.
- Start-up Costs: Establishing new businesses or projects is not supported.
- Clinical and Efficacy Studies: No support for clinical trials or efficacy assessments.
- Financial Interests: No equity holding, purchase rights, or similar financial support.
- Accreditation: Costs or processes for facility accreditation are excluded.
2. Procedural Limitations and Exclusions
Applications will be excluded if they:
- Are non-responsive to the EOI topics.
- Are submitted after the deadline (17:00 SAST, 31 October 2025).
- Are incomplete or missing mandatory documents (e.g., PI CV, B-BBEE certificate/affidavit, or CIPC registration).
- Come from ineligible organisations (e.g., unregistered enterprises or lacking valid B-BBEE documents).
- Are sent to any email address other than: APIIC@csir.co.za.
Principal Investigator (PI) Limit:
Each institution may submit multiple applications, but a single applicant may only lead one proposal as PI (they can still be listed as co-investigator on others).
3. APIIC Rights and Disclaimers
The APIIC reserves the right to:
- Reject incomplete or inadequate applications.
- Amend or withdraw the EOI at any time.
- Decline to fund all available projects or adjust the number of awards based on evaluation and budget.
It also assumes no responsibility for any costs incurred by applicants during the submission or communication process.
How to apply
Application Requirements and Submission: The APIIC requires that all applications adhere strictly to the instructions laid out in the EOI documents.
1. Template Use: Applicants must submit their proposals using the specific APIIC proposal template.
2. Required Documents: The full submission must include:
◦ The fully completed proposal template, in PDF format, signed by both the Principal Investigator (PI) and the relevant institutional authority.
◦ The CV of the principal investigator.
◦ For enterprises, the B-BBEE certificate/affidavit and proof of CIPC registration are mandatory.
3. Naming Convention: Documents must use a specific naming convention.
4. Submission: All application documents must be emailed to Dr Jenny-Lee Panayides at the dedicated APIIC email address: APIIC@csir.co.za. Applications sent to any other email address will be excluded.
5. Deadline: The closing date for applications is 17:00 SAST on 31 October 2025. Applications received after this date and time will not be accepted.
Reasons for Exclusion: The APIIC has stipulated that applications will not be processed or considered if they are deemed incomplete, are received after the deadline, are non-responsive to the specific topics outlined in the EOI, or are from non-eligible organisations (e.g., Enterprises not registered with CIPC, or those without a BEE certificate/affidavit).
Project assessment criteria
1. Project Summary (Section 2.1)
Proposals must outline:
- The current Technology Readiness Level (TRL) and progress achieved to date.
- The plan to advance the process through translational development (TRL 3 → TRL 6+).
- Any prior techno-economic or scalability studies conducted.
2. Differentiating Features and Synthetic Improvement (Section 2.2)
Projects will be evaluated on how the proposed process improves competitiveness through:
- Process Efficiency: Fewer reaction steps, higher yields.
- Cost and Materials: Use of affordable starting materials or existing intermediates.
- Scale-Up Readiness: Employing scalable, high-productivity methods (e.g., telescoping, robust purification).
- Green Chemistry: High atom economy, low waste, recycling of materials.
- Safety: Use of safer, less toxic reagents.
- Manufacturing Technology: Application of modern methods such as Batch, Continuous Flow, Biocatalysis, or Hybrid processes.
3. Market Need and Route to Market (Section 2.3)
Proposals must demonstrate a substantial and well-defined market demand, including:
- Clear Market Need: Description of the problem addressed and estimated market size.
- Target Molecules: Preference for off-patent essential medicines or high-demand molecules in Africa (e.g., antibacterials, antiretrovirals, antimalarials).
- Commercial Strategy: Defined route to market or established partnerships.
4. Intellectual Property (IP) Status (Section 2.4)
Applicants must specify:
- The ownership or licensing status of IP associated with the molecule and process.
- Details of any licensing arrangements.
5. Expected Outcomes and Impact (Section 2.5)
Projects should demonstrate potential social and economic benefits, contributing to local pharmaceutical manufacturing capability and broader developmental impact.
The APIIC follows a rigorous two-step process for reviewing and evaluating proposals:
Step 1: Internal Screening and Alignment Review Internal members of the APIIC first screen all submitted applications. This stage focuses on two key administrative and procedural checks:
1. Responsiveness: Applications are screened to ensure compliance with all administrative and procedural provisions required by the EOI.
2. Capacity Alignment: A review is conducted to ensure the proposed project aligns with the capabilities and available capacity of the implementing partners (the CSIR, specifically the FuturePHARMA facility and R&D biocatalysis laboratories, and Chemical Process Technologies (CPT) Pharma, through the API+ Laboratory).
Step 2: Scientific and Market Merit Assessment Applications that are found to be responsive and aligned with the implementing facilities' capabilities and capacity are then engaged for a more detailed review. This stage utilizes the following information provided by the applicant:
• Detailed proof-of-concept information.
• Assessment of the scientific and technical merit of the preliminary studies.
• Review of market significance.
• Evaluation of the status of Intellectual Property (IP).
• Cost-benefit analysis.
Final Determination and Award: The final award of grants is determined by the APIIC Steering Committee. This committee takes into account the results of the two-step review process.
The Steering Committee’s decision may also be influenced by broader considerations, including:
• National strategic imperatives.
• Additional factors such as geographical and institutional diversity.
• Transformation considerations.
The APIIC reserves the right to award fewer or more grants than anticipated, based on the overall scoring or budget limitations, and may choose not to allocate all available funds from this EOI. Successful applicants may be required to address reviewer comments and/or negotiate the final project plan.
