Isotopia-global

GMP radiometal production and certificate-of-analysis data for Lutetium-177, with an unusually explicit published process model: two competing production routes quantified side by side — direct/carrier-added (irradiation of enriched 176-Lu, ~5% material loss, product carries up to 0.07% long-lived 177m-Lu) versus indirect/no-carrier-added (irradiation of enriched 176-Yb followed by Yb separation, industry-typical ~25% material loss reduced to ~10% by the vendor's proprietary separation). Accompanied by per-batch release specification data (radiochemical purity by iTLC, radionuclidic purity with named impurity ceilings for 175-Yb, 177m-Lu and others, specific activity by ICP-OES at end of production and at end of shelf life, metallic-impurity panel measured per GBq, pH, sterility and bacterial endotoxins), and multi-site production and logistics records across Israel, the USA, Austria and contract sites in Canada, on weekly 52-week production cadence.

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Coverage

Universe, instruments and categories.

Industry: PharmaceuticalsOther Speciality Chemicals
Instruments: equities
Categories: Alternative

Dataset card

Type: not stated
Format: Tabular batch and certificate-of-analysis records: per-batch radionuclidic and radiochemical purity results, ICP-OES specific-activity and metallic-impurity measurements at two timepoints, plus irradiation and separation process parameters; currently surfaced to customers as specification documents and certificates rather than as data feeds
Volume: Low by record count, exceptionally high per-record density: roughly 10^3-10^4 GMP production batches since 2006 across four or more manufacturing sites, each carrying a multi-parameter certificate of analysis measured at two timepoints (inferred from a near-20-year production history on a weekly-to-campaign cadence; supply is measured in curies per shipment — licence correspondence references Lu-177 quantities up to 29 Ci per consignment — not in bulk records)
Users: N/A — GMP isotope producer, not a software platform, so there are no registered users in the usual sense. Scale is instead a customer base of radiopharmaceutical developers, CMOs and research programmes, publicly evidenced by named clinical and commercial supply agreements and by a stated 52-week weekly-supply commitment; realistically low hundreds of institutional accounts.
History: 20 years
Update frequency: not stated
Growth: Active and materially expanding — a stated multi-site manufacturing build-out (Israel, a 30,000+ sq ft GMP facility in Indianapolis, an Austrian partner site and Canadian contract production), documented production-technology transfers to third-party manufacturers with first commercial doses delivered, expansion into Terbium-161 and further therapeutic isotopes, an eQMS implementation, and stated plans for additional sites including Asia
Launched: ~2006-2007 for the company and its isotope supply business (inferred: the vendor's own brochure states a track record since 2006 and its corporate profile records founding in 2007, while the dedicated Lu-177 production programme and the US site followed later as the radioligand-therapy market developed)
Delivery: not stated
Entity mapping: not stated
Sample: not stated
Point-in-time: not stated
Licence: not stated

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