Loading…
Grand River Aseptic Manufacturing
Manufacture high-quality injectable solutions with unmatched agility and reliability
About
Grand River Aseptic Manufacturing (GRAM) is a sterile injectable fill-finish CDMO in Grand Rapids, Michigan, serving clinical through commercial programs. It fills liquid and lyophilized vials, prefilled syringes and cartridges for biologics, small molecules and vaccines, including controlled substances, with formulation volumes up to 1,000 L and terminal sterilization available. Its finishing operation covers automated, semi-automated and manual inspection, labeling, packaging, serialization and aggregation, plus QC analytical testing and controlled-temperature warehousing.
Deterministic scores · rules-based, not AIiHow these scores are obtained: each one is computed from this profile's listed attributes — capability checkboxes, certifications, capacity figures and coverage — by a fixed formula, recomputed on every page load. Deterministic and rules-based means the score comes from a fixed, transparent formula over listed attributes — the same inputs always produce the same score. It is not AI: there is no model, no learning, and no hidden weighting. Whether a score is relevant to you depends on your specific project: a capability that raises the number may not matter for your work, and a niche strength your project needs may barely move it. Capability scores are a directional starting point, not a verdict. A lower score does not disqualify a company or consultant, and no decision should rest on the score alone — always contact the company directly to confirm the specifics for your project.
Manufacturing iCounts how many of the 22 core manufacturing capabilities this profile lists (7 drug-substance, 6 drug-product, 5 advanced-therapy, 4 specialized) - each adds 3.6 points, capped at 78 - plus 2.4 points per therapeutic area covered, capped at 22. Levels: 80+ Full-spectrum CDMO | 60-79 Broad capability | 40-59 Established | below 40 Focused. Whether this dimension matters for you depends on your specific project.
22Focused
Advanced therapy iCounts the 5 advanced-therapy capabilities (cell therapy, gene therapy, viral vectors, CAR-T, exosomes) at 11 points each, capped at 50, then adds bonuses for related depth: biologics drug substance 14, mRNA 12, viral vectors 10, CAR-T 8, plasmid DNA 6. Levels: 80+ ATMP leader | 60-79 Advanced | 40-59 Emerging | below 40 Limited. Whether this dimension matters for you depends on your specific project.
0Limited
Fill-finish iCounts the 6 fill-finish capabilities (vial, syringe, cartridge, blow-fill-seal, isolator, RABS) at 8 points each, capped at 42, plus 16 for sterile injectables, 12 for isolator filling, 8 for RABS. Suite count adds up to 22 more (22 at 20+ suites, 16 at 10+, 10 at 5+, 5 for any). Levels: 80+ High-capacity sterile | 60-79 Strong | 40-59 Capable | below 40 Developing. Whether this dimension matters for you depends on your specific project.
60Strong
Quality iBlends GMP certification (16), Annex 1 compliance (14) and a data-integrity program (10) with reported metrics: inspection pass rate up to 24, quality score up to 18, plus bonuses for low CAPA counts (up to 8) and few audit findings last year (up to 10 for zero). Shows Not reported (score 0) when no GMP flag, pass rate, quality score or data-integrity program is on file. Levels: 80+ Exceptional | 60-79 Strong | 40-59 Solid | below 40 Developing. Whether this dimension matters for you depends on your specific project.
0Not reported
Regulatory iCounts entries in three profile lists: regulatory history (6 points each, capped at 46), inspection authorities (7 points each, capped at 30) and geographic coverage (6 points each, capped at 24). More filings, more agencies and wider geography all raise the score. Levels: 80+ Global reach | 60-79 Multi-region | 40-59 Regional | below 40 Limited. Whether this dimension matters for you depends on your specific project.
18Limited
Capacity iTiers four scale metrics: facilities (up to 28 points at 30+), manufacturing suites (up to 24 at 40+), annual unit capacity (up to 26 at 1,000,000+) and employee count (up to 22 at 10,000+). Each metric earns partial points at lower tiers, so any reported scale contributes. Levels: 80+ Global scale | 60-79 Large | 40-59 Mid-size | below 40 Boutique. Whether this dimension matters for you depends on your specific project.
26Boutique
Capabilities
Sterile fill-finishVaccinesVial fillingSyringe fillingIsolatorClinical mfgCommercial mfg
Technology platforms
Five filling lines with isolator technology; low- and high-speed filling; single-use or product-dedicated equipment; lyophilizer with auto-loader; Stevanato Optrel and Körber automated inspection; Dividella and Marchesini packaging with SEA Vision and TraceLink four-level serialization
Therapeutic areas
BiologicsVaccinesSterile injectables
Live record · illustrative seed data · scores deterministic, rules-based — not AI.