Product Portfolio — Stancor Pharma
Contract and outsource manufacturing for contrast media, oncology injectables, biosimilar programmes and cosmetic formulations — sterile and non-sterile capacity, analytical and stability services, and structured technology transfer.
Iodinated and gadolinium-based imaging agents — large-volume aseptic fill in vials and bottles, with viscosity, osmolality and particulate control.
Contrast media is the formulation family most contract sites quietly decline. Fill volumes run to 100 ml and beyond, the solutions are viscous, osmolality and endotoxin limits are tight, and particulate control has to hold across a long fill with no terminal recovery step for parenteral grades.
Our capability is built for exactly that: aseptic and terminally sterilised filling with in-line filtration, nitrogen overlay where the molecule requires it, automated 100% visual and particulate inspect
- Iodinated formulations (capability)
- Iohexol, iopamidol, iodixanol, ioversol, iopromide — 300, 350 and 370 mg I/ml strengths
- Gadolinium formulations (capability)
- Gadoterate meglumine, gadobutrol, gadodiamide — 0.5 mmol/ml class presentations
- Presentations
- 10, 20, 50, 100 ml vials and 100-500 ml infusion bottles; pre-filled syringe on request
- Batch envelope
- 50 L to 2,000 L per batch, campaign scheduling available
- Sterilisation route
- Terminal moist heat where the monograph permits, otherwise aseptic with 0.22 µm in-line filtration
- Release testing
- Assay (HPLC), osmolality, pH, free ligand, particulate matter, BET, sterility, container closure integrity
Available grades: Iohexol formulations, Iopamidol formulations, Iodixanol formulations, Gadoterate formulations, Infusion bottle filling, Pre-filled syringe (on request)
Cytotoxic and cytostatic injectables in a contained, dedicated suite — liquid vials and lyophilised presentations.
Cytotoxic products cannot share a line with anything else, so this capability sits in a dedicated suite with its own air handling, negative-pressure cascade to the corridor, isolator or restricted-access barrier filling, and separate gowning and material airlocks. Operator exposure is managed to a defined OEL band with containment verified by surrogate monitoring rather than assumed.
Both liquid-fill and lyophilised presentations are supported, with cleaning validation to product-specific MACO
- Formulation classes (capability)
- Generic cytotoxic injectables — taxane, platinum, anthracycline, antimetabolite and vinca classes
- Presentations
- 2-50 ml liquid vials, lyophilised vials, ready-to-dilute concentrates
- Containment
- Dedicated suite, negative pressure cascade, isolator/RABS filling, OEB 4 handling
- Batch envelope
- 10 L to 300 L liquid; 1,000 to 40,000 vials per lyophilisation cycle
- Cleaning validation
- Product-specific MACO with swab and rinse recovery, HPLC-verified
- Release testing
- Assay and related substances (HPLC), water content (KF) for lyophilised, BET, sterility, CCIT
Available grades: Liquid vial filling, Lyophilised vials, Ready-to-dilute concentrates, Contained weighing & compounding, Cytotoxic cleaning validation, Dedicated change-over protocol
Development-stage support for biosimilar programmes — formulation, fill-finish engineering batches, analytical comparability and stability.
This is deliberately described as programme support rather than product supply. We do not hold biosimilar marketing authorisations and do not present any biosimilar as a finished licensed product. What we offer is the development and fill-finish capability a programme needs between drug substance and a regulatory submission.
That means formulation and excipient screening for aggregation and oxidation, engineering and clinical-supply batches in vials or pre-filled syringes under cold-chain contr
- Programme scope
- Formulation development, engineering batches, clinical supply, comparability and stability — development stage only
- Therapeutic areas explored
- Oncology mAb programmes, supportive-care proteins, insulin-class and fusion-protein programmes
- Fill-finish
- 2-20 ml vials and pre-filled syringes, aseptic, 2-8 °C cold chain maintained end to end
- Analytical
- SEC, CEX, CE-SDS, peptide mapping, sub-visible particles, potency assay (partner lab where specified)
- Stability
- ICH long-term, accelerated and photostability with sponsor-approved protocol
- IP position
- Sponsor retains cell line, process and data; Stancor provides capacity and documentation
Available grades: Formulation screening, Engineering batches, Clinical trial supply, Analytical comparability, Cold chain fill-finish, Stability programme management
Creams, serums, gels, lotions and cleansers — formulation development, scale-up and filling for own-brand and private-label ranges.
Cosmetics carry a lighter regulatory load than parenterals and a heavier aesthetic one. A cream that separates at 40 °C, a serum that discolours under light or a gel that changes viscosity in month four will be rejected by consumers long before any regulator comments.
Our capability covers emulsion and gel formulation development, actives stabilisation (vitamin C derivatives, retinoids, niacinamide, peptides, AHA/BHA systems), preservative efficacy testing to ISO 11930, pilot scale-up and filli
- Formulation types
- O/W and W/O emulsions, serums, aqueous and alcoholic gels, lotions, cleansers, masks, balms, micellar systems
- Actives handled
- Vitamin C derivatives, retinoids, niacinamide, peptides, AHA/BHA, ceramides, botanical extracts, mineral and chemical UV filters
- Batch envelope
- 25 kg pilot to 5,000 kg production, vacuum homogenisation
- Filling
- Jars, tubes, bottles, airless pumps, roll-ons and sachets; 5 ml to 500 ml
- Testing
- Viscosity, pH, globule size, centrifugation, freeze-thaw, PET per ISO 11930, heavy metals, microbial limits
- Dossier support
- Product information file, stability data and specification sheets for registration
Available grades: Emulsions & creams, Serums & essences, Gels & hydro-alcoholic systems, Lotions & body care, Cleansers & micellar, Sun care formulations
Non-cytotoxic small-volume and large-volume parenterals — vials, ampoules, pre-filled syringes and lyophilised presentations.
The general injectable block runs non-cytotoxic sterile products across liquid vials, ampoules, pre-filled syringes and lyophilised vials, with terminal sterilisation wherever the monograph allows it and aseptic processing where it does not.
Lines are qualified with media fills at the stated frequency, environmental monitoring runs continuously in Grade A and B areas, and every batch carries a complete executed batch record, deviation log and release data pack. Container closure integrity is te
- Presentations
- 1-50 ml vials, 1-20 ml ampoules, 0.5-10 ml pre-filled syringes, lyophilised vials
- Therapy areas (capability)
- Anti-infectives, analgesics, anaesthetics, steroids, electrolytes, vitamins and supportive care
- Batch envelope
- 20 L to 1,500 L; 5,000 to 150,000 units per batch depending on presentation
- Sterilisation
- Terminal autoclave (F0 validated) or aseptic with 0.22 µm sterilising filtration and filter integrity testing
- Environment
- Grade A filling under Grade B background, continuous viable and non-viable monitoring
- Documentation
- Executed BMR, deviations, release data pack, CoA and CoC with every batch
Available grades: Liquid vial filling, Ampoule filling, Pre-filled syringes, Lyophilised vials, Terminal sterilisation, Aseptic processing
Tablets, capsules, syrups, suspensions and dry powders — development batches through to commercial campaigns.
The oral block covers immediate and modified release tablets, hard gelatin and HPMC capsules, film coating, and liquid orals including syrups, suspensions and dry powder for reconstitution.
Granulation is available as wet, dry and direct compression, with blend uniformity and content uniformity established during scale-up rather than assumed from the development batch. Dissolution profiles are developed in house across multiple media, which is usually where a transferred product either succeeds
- Dosage forms
- Immediate and modified release tablets, film-coated tablets, hard capsules, syrups, suspensions, dry syrups, sachets
- Granulation
- Rapid mixer wet granulation, fluid bed, roller compaction and direct compression
- Batch envelope
- 25 kg to 500 kg blend; 50 L to 5,000 L for liquid orals
- Packing
- Alu-alu, blister, HDPE bottles, strip packing, bottles with measuring devices
- Development support
- Dissolution profiling in multiple media, blend and content uniformity, hardness and friability optimisation
- Stability
- ICH Zone IVb long-term (30 °C/75% RH) and accelerated (40 °C/75% RH)
Available grades: Immediate release tablets, Modified release tablets, Hard capsules, Syrups & suspensions, Dry powder for reconstitution, Sachets & granules