October 28, 2019 PAP-Q3-19-CL-002
Aspen Pharmacare offers an extensive portfolio of cost-effective, high-quality, niche manufacturing capabilities across a global network. We have a range of scalable production capabilities and capacities aligned with our current and future commercial objectives, including injectables, oral solid and semisolid, liquids and active pharmaceutical ingredients (APIs).
We operate 23 manufacturing facilities across 15 sites, and we hold international manufacturing approvals from some of the most stringent global regulatory agencies, including the United States Food and Drug Administration, the Australian Therapeutic Goods Administration and the European Directorate for the Quality of Medicines. We operate with an established business presence in approximately 56 countries/regions and supply products to more than 150 countries.
We focus on achieving efficiencies across our global manufacturing network through vertical integration of many aspects of our supply chain, combined with end-to-end global supply chain management overseen by a highly experienced team.
The strategic approach to manufacturing at Aspen Pharmacare centers around five primary manufacturing sites that serve as specific centers of production excellence. These five locations — Notre Dame de Bondeville in France, Oss in The Netherlands, Bad Oldesloe in Germany, and FCC Cape Town and Port Elizabeth in South Africa — each offers specialist capabilities and expertise.
Several additional regional facilities supply local/regional needs across diverse territories, including Brazil, Australia and multiple African countries. We also have a product development site in Hyderabad, India that supports commercial manufacturing programs.
All of the manufacturing centers are closely integrated. Manufacturing and leadership councils comprising the various business heads are in constant communication, sharing challenges and best practices and looking for common solutions. They all share a commitment to quality and customer service and a desire to optimize operating efficiency and productivity to ensure the manufacture of high-quality products.
Aspen Notre Dame de Bondeville, located in France, offers brand-new high-quality, automated, prefilled syringe (PFS) filling under isolator with E-beam and automatic inspection. NDB’s manufacturing capability for PFS is as automated as any CDMO in the industry. Today, 90% of products manufactured at Aspen NDB are exported to regulated markets around the world, including North America and Japan.
In addition to thrombosis products (e.g., heparin, synthetic factor Xa inhibitor), NDB produces diluents for vaccine reconstitution. The NDB site has been audited by many regulatory authorities, including ANVISA (Brazil), ANSM (France), EMA (Europe), FDA (USA), HPB (Canada) and JMHRA (Japan).
Over the past five years, Aspen Pharmacare has invested more than €70 million in the NDB site and has committed an additional €100 million over the next five years. In response to growing demand for both heparin products and sterile products in PFS (which are considered a safer and more reliable delivery option) NDB is currently constructing a new state-of-the-art facility for anesthetics, including additional capacity for blow–fill–seal (BFS). The latest PFS line to be installed (Groninger) will be dedicated to contract manufacturing projects and will be operational in Q1 2020.
“We welcome all potential customers who are looking for a high-quality solution for their prefilled syringe projects. The new, state-of-the-art automated and contained filling line is backed by a track
record of excellent customer service, which is reflected in our 95+% on-time, in-full delivery rate,” remarks Jean-Charles Rousset, site director of the NDB facility. The high level of automation ensures a low level of quality deviations that could delay product supply. Dedicating our third PFS line to our CDMO business means that potential customers will benefit from accessing the flexibility and dedication of a pure CDMO offering while still leveraging the expertise and quality commitment of an embedded CDMO.
We have also developed intellectual property around a PFS device technology for enhanced safety, and are open to discussion with future clients about providing this technology for their products.
Aspen Pharmacare’s Oss business in the Netherlands is a manufacturing center of excellence for biochemical and chemical APIs, including steroid hormone products and peptides. Founded in 1923, it has a long history in the production of heparin which is produced from waste material taken from slaughterhouses. Aspen Pharmacare acquired the Oss facilities from Merck in 2013.
Aspen Oss has a proud history of almost 100 years in the production of complex and highly potent APIs (HPAPIs) and works from a deeply rooted and proactive quality culture. Given the nature of handling HPAPIs, world-class systems and procedures have been established for the safe handling of these compounds. We have a long history of working with OEL levels going as low as 0.01ug/m3.With a highly dedicated crew of professionals,we are capable of producing and releasing more than 50 different APIs. We offer our customers a true partnership by consistently delivering high product quality on schedule with extensive regulatory filing support.
The business comprises facilities located at De Geer, Moleneind and Boxtel. The Moleneind site includes peptide manufacturing, biochemical (heparin) manufacturing and small-scale chemical manufacturing. The De Geer facility is a modern and large-scale chemical manufacturing site with reaction vessels up to 10,000 L. The sieving, miling and micronization of the final APIs are also handled here. Boxtel is a dedicated state-of-the-art manufacturing site for the production of chorionic gonadotrophin, including capabilities for virus filtration.
Aspen Oss is well integrated within the entire Aspen Pharmacare manufacturing network. Furthermore, it has for many years served a stable customer portfolio, including global multinationals, generic manufacturers and innovative new tech start-ups. Aspen Oss has been audited and certified by all of the major health authorities.
On average, Aspen Pharmacare has invested approximately €20 million per year to maintain and upgrade the broad portfolio of capabilities at the three Oss sites. Dirk van Leemput, Oss site director, states, “We are also working intensively to increase our efficiency and productivity. These ongoing efforts continue to reduce our operating costs and free up additional capacity for new projects.”
The Bad Oldesloe, Germany facility is a center of excellence for finished dose manufacturing of solids, semisolids and topical liquids, as well as BFS processing and full-service packaging, including secondary packaging and serialization. The site was established in 1973 and acquired from GlaxoSmithKline in 2009. We currently supply Europe, Japan and other international locations; in all, we supply 170 customers in 130 countries.
Our unique capabilities include low-dose (microgram) solid drug manufacturing, segregated, highly contained processing of highly potent APIs down to occupational exposure band 5 (OEB-5), solid and semisolid hormone and the production of controlled substances. In addition, we offer testing and release services and hub services for APIs and finished packs.
At Bad Oldesloe, we have been providing contract development and manufacturing services for very small– to large-volume products for many years. Our capabilities and technical expertise for product transfers reflect a high number of successful transfers over the last 20 years.
“Our CDMO customers benefit from the long-standing and stable employee base at the site. More than a quarter of the staff have worked at the facility for more than 20 years and have extensive experience in the tech transfer process,” says Andrea Bretschneider, site director at Bad Oldesloe.
Over the last ten years, Aspen Pharmacare has invested approximately €55 million has been invested to upgrade our facilities and add new equipment to ensure we maintain state-of-the-art operations.
Aspen Pharmacare’s FCC Cape Town site is also a center of excellence for API manufacturing and has been providing contract development and manufacturing services for over 54 years. Established in 1965, the high-containment multipurpose site focuses on classical chemical synthesis and the extraction of natural APIs from plants. Overall, the facility has 38 active products in manufacture and supply supported by 212 regulatory filings in 41 countries, with the United States being its primary market. It has been audited by all leading regulatory authorities and has never received any critical findings, reflecting the fact that quality is the cornerstone of its culture.
“We have invested heavily in highly efficient, and versatile state-of-the-art containment facilities, engineering protection into our systems rather than relying on personal protective equipment, as is the case with all Aspen sites. With our high quality and automated systems, we can be very competitive,” states Andre van der Walt, the site director at Aspen’s API facility in Cape Town.
Products are manufactured in 10 segregated production buildings comprising 24 process centers, using equipment constructed with a diverse array of materials and protected by a wide range of containment technologies. Capacity is product specific and currently ranges from 1–3 kg pa output for highly specialized ONCO products, to 20 tonnes pa for HPAPI products. All process and analytical method development and scale-up activities are performed in house, allowing us to provide support on lab scale (gram quantities), pilot plant scale (1–10 kg) and commercial scale (up to 500 kg batch size).
Over the past five years, Aspen has invested close to $105 million in the FCC Cape Town site, building three new facilities, including a process center for hormones and cytotoxics with the highest levels of containment. Today, we can offer containment at the 1 ng/m3 down to the 10 ng/m3 level.
The FCC Cape Town site also benefits from its location in South Africa and its place within the Aspen network, with the Port Elizabeth finished dosage manufacturing plant located just up the coast.
The Aspen Pharmacare site at Port Elizabeth, South Africa is a center of excellence for sterile and solid finished dosage manufacturing and packaging, including high-containment OSD, hormone OSD, oral contraceptive OSD, and ophthalmics. The site has received accreditation from regulatory authorities in North and South America, Europe, Australia and Africa and serves both the domestic and international markets.
Port Elizabeth specializes in sterile drug products packaged into vials and ampoules, as well as eyedrops using a three-piece dropper technology and various OSD forms.
Over the past five years, Aspen has invested ~€300 million in the Port Elizabeth site to increase efficiency and productivity and to construct a new sterile fill-finish facility for the production of vials, ampoules and PFS. This facility is due to start commercial operations in Q4 2019.
“Customers benefit from not only these advanced technologies, but the packaging and technology transfer expertise of our employees, many of whom helped transfer in the initial products when the facility, which previously resembled an R&D center, opened 20 years ago,” says Grant Swart, site director for Port Elizabeth.
Our global network of highly integrated and advanced centers of manufacturing excellence, and our commitment to ongoing investment in complex, state-of-the-art manufacturing capabilities, make Aspen Pharmacare the ideal choice as a contract development and manufacturing partner. We can support your needs for API and drug substance manufacture from grams to tonnes for solid, semisolid and liquid products.
Let us leverage our geographic footprint, valuable infrastructure and extensive portfolio of manufacturing capabilities to meet your challenging pharmaceutical production needs. We are enthusiastic about providing the benefits of our extensive manufacturing experience — including niche, in-demand capabilities — to other innovator pharmaceutical companies and ultimately to the final and most important customer, the patient.
Lorraine Hill graduated from Rhodes University with a B. Pharm degree and formally entered the pharmaceutical industry in 1987. In 1994, she joined Garec Pharmaceuticals to head up the Regulatory Affairs department and later took up the pharmaceutical responsibility of Managing Director. Garec was integrated into Aspen in 1998, and as such she has worked for the Aspen Group, through this combined tenure, for more than 21 years. Over the past 9 years, responsibilities have grown from managing the Regulatory Affairs department at Aspen to being appointed the Group Operating Officer, reporting directly to the Group Chief Executive.