Case Study #1
Major multinational photographic Company, looking to outsource multi-stage synthesis to China
- Customer first contacted SH in October.
- Two potential suppliers selected and quotes submitted within one month.
- CDAs signed in November, leading to detailed discussions between customer, SH and the suppliers regarding production routes, test methods etc.
- Samples produced by both suppliers by April of the following year and rapidly validated by customer QC.
- Quotes confirmed by suppliers in May followed by trial orders for 10 kgs.
- Based on assessments, quality achievement and price projections, a larger delivery of 100kgs was ordered and supplied in July by the selected supplier.
- Routine commercial deliveries commenced in December and continue to this day.
New Molecule Development
Case Study #2
- Large European Pharma Company required a new molecule, not available on the open market (7-membered ring with ketone substitution and protection of active site) in quantity and on-time to fit with a key and rapid clinical trial programme
- Late July, liaison with development partner Company under both general long term and specific project CDAs.
- Early August, projections on costs, lead time and quality:
Showed 2 optional routes, each of 6 stages with key RM, process, technology, asset, operability and environmental impacts.
Combined risk study led to preferred route selection.
- Customer committed by mid-August with demand increased from 10 kgs to 30 kgs and with delivery end November; order placed with partner development company.Agreements and programme established with weekly reports and feedback together with periodic meetings on "as-needed" basis.
- Mid September initial gm product sample with analysis by NMR and initial GC using method developed in-house.
- Early October 10 gm sample with NMR and established GC.
- Mid November prime manufacture completed: 35 kgs at 96.9%.
- Smaller scale high vacuum distillation led to 30.8 kgs product at 98.4%; delivered on time.
Case Study #3
- In March a European contract manufacturing company requested details for supply of large tonnage amounts of a product established at regular full scale but needing very demanding specification limits on specified impurities.
- Within a week, SH identified several (>6) suppliers; during detailed discussions, a number were disqualified.
- Two remaining suppliers were visited in early April for detailed investigation and audit along with detailed risk, route, quality and price discussions, leading to selection of a preferred option, plus a fall-back.
- Detailed report forwarded to the potential client leading to agreement by mid April and provision of their QC approach under confidentiality to the prime supply Company.
- Limited and mutually committed development and improvement programme undertaken under the guidance of SH to resolve minor issues in approach, systems and procedures of the manufacturer over a 3-month period.
- Material was supplied for assessment and validation by the customer
Low 00’s gms dispatched late April with customer validation by late May;
Few 00’s kgs freighted early July, undergoing trials and assessment by end September.
- Bulk supply contract established, initially in provisional form.
- In December, customer visited manufacturing site to complete and satisfy its internal audit needs.
- Contract formally confirmed and now matured at a few 00’s tons per annum, meeting the needs of all involved, with simple and clear paths of communication established.