Manufacturing is intentionally phased.
The Houston manufacturing program is being developed against real product needs, regulatory control requirements, supply timing, transferable rights, realistic volume, and long-term economics.
Facility scope follows the first approved portfolio.
FG is developing a phased Houston-area manufacturing program. Site scope, engineering, permitting, and technical approvals remain in progress. The final configuration is intended to be set against approved product requirements rather than built around assumptions that may change after diligence.
- Qualified partners or existing capacity may be used where they are faster or lower risk.
- Selected processes may be internalized where scale, control, economics, and rights justify it.
- Dedicated modules are added only when launch portfolio and continuity needs support the investment.
- Strong internal quality and technical oversight begin before full internal capacity exists.
A product-by-product manufacturing model.
Drug Substance / Biologics
Use qualified partners or existing capacity where that is the fastest and lower-risk path; internalize selected processes only when justified.
Plasma Fractionation / Purification
Define partner, contract, transfer, or internal options by product before committing to dedicated capacity.
Fill-Finish / Packaging
Use qualified capacity while internal requirements are defined; add dedicated modules where continuity and portfolio needs support them.
QC / Analytical / Release
Establish strong internal oversight from the beginning and increase testing and release capability as product and site scope mature.
Supply Chain / Cold Chain
Secure qualified suppliers, logistics, inventory rules, and continuity plans around approved products and customer-service needs.
Technology Transfer
Use traceable deliverables, process and analytical gap assessment, quality agreements, change control, and readiness gates.