This is a firm fixed price fornew plga analytical methods for mini-size complex long-acting injectable formulations.
Active Definitive Contract Awarded Last action
- Contract number
- 75F40123C00192
- Awardee
-
Akina, Inc. UEI WTBLC3LE13U1
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $1,211,682
Award facts
- Opportunity
-
- FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Solicitation · FDABAA2300123 · Posted Nov 14, 2022
- Contract value 100% obligated
- $1,211,682.00 Current and potential, with all options
- Completion date 94% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Two Step
- Pricing
- Firm Fixed Price
- Place of performance
- West Lafayette, IN, USA
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Exercise an Option | $283,778 | |
| Other Administrative Action | $0 | |
| Exercise an Option | $272,094 | |
| Original award | $655,810 |
About this award
The Food and Drug Administration awarded a $1.21M firm-fixed-price definitive contract to Akina, Inc., a minority-owned research company based in West Lafayette, Indiana, for the development of new analytical methods for miniaturized poly(lactide-co-glycolide) (PLGA) complex long-acting injectable formulations. The contract, awarded on September 26, 2023, with an ultimate completion date of December 31, 2026, was issued under the FDA's Broad Agency Announcement solicitation that sought proposals to advance regulatory science and innovation across modernized product development and evaluation, strengthened post-market surveillance, and public health preparedness. No set-aside designation was used in this competitive procurement. The work will be performed in West Lafayette, Indiana, and supports the FDA's mission to evaluate and advance understanding of complex pharmaceutical formulations.
Akina, Inc. brings significant expertise in controlled-release drug delivery and biomedical applications, particularly in PLGA microparticle technology, having been founded in 2001 by Dr. Kinam Park near Purdue University. The company has demonstrated success in this technical domain through concurrent work with the National Institute on Drug Abuse to develop injectable buprenorphine formulations for treating opioid use disorder. This FDA contract builds on Akina's established capabilities to enhance the regulatory science toolkit available to the agency for evaluating innovative long-acting injectable products, supporting both pre-market product evaluation and post-market surveillance activities.
Quick answers
Who was awarded contract 75F40123C00192?
75F40123C00192 was awarded to Akina, Inc. by Food and Drug Administration (Department of Health and Human Services) on September 26, 2023.
How much is contract 75F40123C00192 worth?
The government has obligated $1,211,682 on 75F40123C00192.
Was contract 75F40123C00192 competed?
The extent of competition for 75F40123C00192 was full and open competition. The government received 1 offer.
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