In August 2014, Merck Serono began building a pharmaceutical manufacturing facility in Nantong, China.
Aspen is a leading supplier of branded and generic pharmaceuticals worldwide. Aspen has manufacturing facilities on six continents; its products are renowned for their quality, effectiveness and affordability.
At Aspen’s pharmaceutical manufacturing facility in Bad Oldesloe, Germany, more than 1,000 different products are produced and distributed to 130 countries for many international pharmaceutical partners.
Pharmaceutical contract manufacturing and primary and secondary packaging
The Bad Oldesloe facility offers pharmaceutical contract manufacturing and primary and secondary packaging services for the international market’s EU QP release and clinical trial packaging.
The facility meets stringent quality standards and is Good Manufacturing Practice (GMP) certified by the European Union and by many other national regulatory authorities. It operates in accordance with integrated quality (DIN EN ISO 9001:2008), environmental management (EN ISO 14001:2004) and health and safety (OHSAS 18001:2007) management systems.
Aspen Bad Oldesloe
Contract manufacturing of tablets, liquids, packs and SKUs
The Bad Oldesloe facility offers advanced manufacturing capability and a wealth of technological experience in its committed and competent team. The facility’s production volumes for 2010 were: 2.7 billion tablets, 6,200 kilolitres of liquids, 37 million units of blow fill seals, 55 million finished packs, and more than 1,000 SKUs.
Contract services for pharmaceutical solids
Aspen Bad Oldesloe offers a range of contract services for the manufacture and packaging of solids. These include granulation and drying, including spray granulation; coating; and Occupational Exposure Band 5 manufacturing and packaging. The facility can cater for low-dose products. Packaging sizes range from 100 to 100,000 packs, including:
- Blister packaging: PVC, PVDC, Aclar, Alu/Alu, including late-stage printing on foils
- Bottle packaging, including the application of desiccant, induction sealer and child-resistant caps
- Application of 2D Data Matrix Code, vignettes and tamper-evident labels
Contract manufacturing of pharmaceutical liquids and semi solids
Aspen Bad Oldesloe carries out contract manufacturing of pharmaceutical liquids and semi solids, including orals, topical liquids, creams, ointments, suspensions and solutions. The facility can also handle flammable liquids.
Batch sizes range from 500l to 8,000l, and the facility’s capabilities include glass and plastic bottle packing, including child-resistant caps, dosage devices, and the application of 2D Data Matrix Code, vignettes and tamper-evident labels.
Form fill seal services
Aspen Bad Oldesloe’s form fill seal services include:
- Aseptic filling into polyethylene vials
- Bottle pack capabilities for 0.4ml to 5ml fill volume
- Foil wrapping (including nitrogen gassing)
- Labeling of vials, including 2D Data Matrix Code, vignettes and tamper-evident labels
Small-scale equipment for pharmaceutical trials and formulation
The facility has a range of small-scale equipment for pharmaceutical trials and formulation, to support the contract manufacturing services on offer.
- Artwork management
- Electronic process instructions and batch recording
- Support in the procurement of raw materials and components
- Transfer and development of analytical methods
- Clinical study supply of products
- Pack consolidation and optimisation
- ICH stability studies
- EU testing and release
Pharmaceutical product warehousing and distribution services
Aspen’s Bad Oldesloe facility has a wealth of international logistics experience. It has more than 170 customers in around 130 countries and can act as a cross dock / hub for transport consolidation / bonded warehousing.
The warehouse has both ambient and cold storage capabilities (2°C to 8°C) as well as a vault for controlled substances (level 9 security). The site has good traffic infrastructure, with access to two airports (Hamburg and Luebeck) within 40km, and is close to Hamburg sea port – the largest German container port.
In August 2016, German pharmaceutical company Fresenius Kabi announced plans for an expansion of the pharmaceutical manufacturing capabilities of its site in Melrose Park, Illinois.
Danish pharmaceutical company Novo Nordisk broke ground on its diabetes active pharmaceutical ingredients (DAPIs) production facility in Clayton, North Carolina, in March 2016.