From complex tech transfers to rapid scale-up for hospital tenders — these case studies reflect the real challenges our manufacturing partners brought to Addams and the outcomes we delivered.
A mid-sized Indian generics company had secured a government hospital tender for Enoxaparin 40mg PFS but lacked the aseptic PFS filling infrastructure internally. They needed a GMP-certified CDMO partner capable of handling LMWH's complex viscosity profile and anti-Xa potency validation within a 6-week tech transfer window.
Enoxaparin's biological activity (anti-Xa potency) requires batch-specific chromogenic assay validation — a complex QC step most CDMO facilities outsource. The partner needed in-house validated testing to meet tender timelines.
Addams deployed a validated chromogenic anti-Xa assay protocol on Line B's QC infrastructure. Fill parameters were optimised for LMWH's 50–100 cP viscosity range, and preservative-free rubber plunger compatibility was confirmed before first GMP batch.
Tech transfer completed in 5.5 weeks. First commercial GMP batch of 500,000 Enoxaparin 40mg PFS released within specification. Tender supply met on schedule with zero batch failures.
An ophthalmology-focused branded generics company needed a preservative-free Timolol 0.5% formulation for a new hospital segment launch. Their previous CDMO could not achieve the required sterility assurance level (SAL 10⁻⁶) consistently, leading to batch rejections. They switched to Addams' Line A ophthalmic facility.
Preservative-free single-dose Timolol requires ISO 5 classified filling with 0.22µm terminal filtration. The previous CDMO's environmental monitoring data showed recurring particulate exceedances in the aseptic core zone.
Line A's ISO 5 cleanroom underwent a dedicated environmental qualification run. LDPE ampoule fill-seal parameters were re-optimised for Timolol's pH 6.8 formulation. A 28-day in-use stability study was completed concurrently with validation batches.
Three consecutive validation batches passed sterility and particulate testing. Monthly supply of 250,000 preservative-free Timolol units commenced on schedule. Zero environmental monitoring exceedances in first 12 months of commercial production.
A private hospital network's pharmacy procurement team sought to replace an imported ready-to-use Nicardipine 0.1 mg/mL infusion with a domestically manufactured alternative. The clinical pharmacist team required a validated compatibility profile with three different ICU infusion pumps before approving the switch.
Nicardipine is photosensitive and adsorbs onto standard PVC infusion tubing. The hospital required DEHP-free compatibility data and photostability validation under standard ICU lighting conditions — data not available for any domestic manufacturer.
Addams formulated in amber glass vials with nitrogen headspace protection. Photostability testing per ICH Q1B was conducted with hospital ICU lighting simulation. DEHP-free compatibility data was generated across three pump/tubing combinations requested by the clinical team.
Complete compatibility and photostability dossier delivered in 10 weeks. Hospital formulary approved Addams' Nicardipine RTU vial across all five hospital sites. Quarterly supply of 100,000 vials with same-day batch release reporting commenced.
A haematology-focused specialty pharma company wanted to consolidate two IV nutrition SKUs — Ferric Carboxymaltose and Vitamin B Complex — with a single CDMO partner. Both products required concurrent tech transfer to reduce administrative complexity and achieve a single audit relationship.
Ferric Carboxymaltose requires validated endotoxin control below 0.25 EU/mL — significantly more stringent than standard parenterals. Vitamin B Complex's riboflavin component is photosensitive requiring amber glass and light-protected processing. Running both TTRs simultaneously risked timeline conflicts.
Addams allocated Line A to Vitamin B Complex (amber glass, light-excluded filling) and Line B to Ferric Carboxymaltose (with dedicated endotoxin in-process testing). Project management ran parallel TTR tracks with shared QA oversight — weekly joint review meetings with the partner's regulatory team.
Both products completed validation within a 10-week concurrent program. Combined monthly output of 80,000 vials achieved by Month 3. Single audit event covered both products, reducing the partner's vendor management overhead by 50%.