Grand River Aseptic Manufacturing vs ROIS

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Category	Grand River Aseptic Manufacturing	ROIS
Listed site	cdmo	cdmo
Summary	Sterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines.	Sterile fill-finish CDMO for biologics, vaccines and ADCs, offering prefilled syringes, cartridges and vials across five US and European sites. It also supports oral solid dose manufacturing and drug substance development.
Services	Sterile Fill-Finish & Aseptic Manufacturing Vial Filling Prefilled Syringe (PFS) Filling Cartridge Filling Lyophilization (Freeze Drying) Quality Control Testing Secondary Packaging & Labeling Serialization & Track-and-Trace Stability Testing & Storage CMC Analytical Development Technology Transfer CMC Regulatory Submission Support Controlled Substance Manufacturing Vaccine Manufacturing Monoclonal Antibody (mAb) Manufacturing Biologics Development & Manufacturing API Synthesis & Manufacturing Small Molecule Development & Manufacturing	Sterile Fill-Finish & Aseptic Manufacturing Prefilled Syringe (PFS) Filling Cartridge Filling Vial Filling Lyophilization (Freeze Drying) Oral Solid Dosage Manufacturing Secondary Packaging & Labeling Combination Product Assembly & Final Packaging Stability Testing & Storage CMC Analytical Development Quality Control Testing Vaccine Manufacturing
Modalities	Small Molecule Biologics (Monoclonal Antibodies) Biologics (Other) Vaccine	mRNA Vaccine Peptide Antibody-Drug Conjugate (ADC) Biologics (Monoclonal Antibodies) Biologics (Other)
Indications	Data not yet provided.	Data not yet provided.
Locations	Headquarters, Grand Rapids, Michigan, United States Headquarters	Phoenix, Phoenix, USA Madrid, Madrid, Spain San Sebastián de los Reyes, San Sebastián de los Reyes, Spain Alcalá de Henares, Alcalá de Henares, Spain Granada, Granada, Spain
Certifications	GMP · Identifier: Five GMP manufacturing facilities Annex 1 · Identifier: Three facilities designed and qualified with Annex 1 revisions GMP · Identifier: Five GMP manufacturing facilities; three Annex 1 compliant FDA · Identifier: GMP EMA · Identifier: Annex 1 GMP · Identifier: Five GMP manufacturing facilities (three Annex 1 compliant)	Data not yet provided.
Reviews	Review summary appears after site-level review signal gate opens.	Review summary appears after site-level review signal gate opens.