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    Drug Approvals by the Medicines Control Council in South Africa of Aspen API. Original Data : South African Medicines Price Registry

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    Nieké van Gils, Jr. scientist at Aspen API on international women’s day.

    07 Mar 2024

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    Gold Medal for Aspen API in EcoVadis Evaluation

    31 Oct 2023

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    Fine Chemicals Corporation facility in Cape Town, South Africa was inspected by the PMDA.

    31 Oct 2023

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    Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen API works tirelessly to deliver top-quality APIs to clients worldwide. Aspen API has a portfolio of over 58 high-quality APIs, including high potency, oncology, peptides, narcotics, analgesics, botanical extractions, and biochemicals. Aspen API places a strong emphasis on sustainability. It employs eco-friendly technologies and solvents in its chemical processes, ensuring responsible and environmentally conscious manufacturing.

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    INTERVIEW #SpeakPharma

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    “Our API is a critical resource that’s managed in an innovative, competitive way”

    “Our API is a critical resource that’s managed in an innovative, competitive way”

    This week, SpeakPharma interviews David Demailly, API Commercial Director at Aspen API and part of the Aspen Pharma Group, a global specialty and branded pharmaceutical company. Aspen API has nearly 100 years of experience in developing and manufacturing active pharmaceutical ingredients (APIs). Demailly discusses Aspen’s expertise, solutions and sustainability efforts that have led to the success of the company.  Tell us about Aspen’s history, its culture and its manufacturing. Aspen API is the cooperative force of Aspen Oss in the Netherlands, Fine Chemicals Corporation in South Africa and Aspen API Inc in Sioux City, Iowa, USA. In 2023, Aspen API will celebrate 100 years of API development and manufacturing. We are a driven and collaborative partner in the development, manufacturing and registration of complex and highly potent active drug ingredients, which are utilized in the production of finished dosage forms. Through our global network of customer relationships, Aspen supplies high-quality APIs that in turn help improve the lives of patients every day. We have a global manufacturing network, with facilities in the Netherlands, South Africa and the USA. We also use a network of partnerships in India and China. This extended network mitigates the concerns around the security of global supply. During the Covid pandemic, we remained focused on the needs of our customers and their patients, ensuring continuity of supply of critical APIs to treat Covid, including the expansion of our capacity for those medications. Our workforce of over 1,200 employees is committed to ensuring continuity of supply of our critical products. Aspen API provides our customers with the highest quality products and brings the most effective solution to each customer. To achieve that goal, we take initiative, we work as a collaborative team, and we innovate.   What makes Aspen API’s portfolio special? Commitment to quality, safety, innovation, security of supply, compliance and sustainability is in our organizational DNA. Thanks to our people, we are able to offer more than just APIs to our customers. Our strong portfolio includes 65 high-quality APIs across a broad range of therapeutics and chemical process categories, such as high-potency APIs, peptides, oncology APIs, narcotics, analgesics, botanical extraction APIs and biochemical APIs. We have an active new product development process that utilizes market intelligence, which when coupled with our technical expertise, is able to establish new API products that meet the growing needs of the pharmaceutical industry. We are always on the lookout for new ideas and opportunities. Our customers, as well as the international health authorities, including the US Food and Drug Administration (FDA), the European Directorate for the Quality of Medicines (EDQM), Dutch health authorities and the Pharmaceuticals and Medical Devices Agency (PMDA), have repeatedly confirmed that we are a reliable API provider. Each week, we welcome (virtual) inspection teams to our sites, and take pride in each successful inspection. With 300 active Drug Master Files worldwide, we comply with the highest global standards and have comprehensive experience in dealing with regulatory authorities worldwide.  How does Aspen API view the collaboration with its customers? We strongly believe in the chemistry of collaboration, at all stages. We work together as partners. Whether the project involves a new chemical entity or a process for (re-)designing an (intermediate) API, we work from the development phase to the commercial implementation stage. Fostering close collaborative relationships with our customers and utilizing our broad technical expertise and long industry experience, we strive to not only understand our customers’ needs, but also to contribute proactively in discussing more effective, efficient and sustainable solutions to their manufacturing requirements.   Is sustainability important to Aspen API? Sustainability is a critical building block for the future at Aspen API. Our aim is to minimize our carbon footprint and be a leader in sustainable API manufacturing. Wherever possible, we use green technology and green solvents in our chemical processes. We provide a safe and healthy workplace for our employees, and offer fair pay, excellent education and equal opportunities. While assessing the impact of our environmental, social and corporate governance, we consider our entire supply chain. We are actively involved with various organizations, including Ecovadis, the Carbon Disclosure Project, Ecodesk and the Pharmaceutical Supply Chain Initiative.  Can you throw some light on your green solutions? Our technical team has developed a patented method for green and large-scale manufacturing of peptides in a solution called Green Continuous Liquid Phase Peptide Synthesis (Green Continuous-LPPSTM). This method combines the advantages of the classical solution-phase synthesis with the solid-phase approach and is characterized by the fact that intermediates are not isolated. This enables a highly efficient synthesis method that is easy to scale-up and yields products of reproducible high purity. In another example, we have developed an enzymatic route towards a hormone API, through which we use 72 percent less water, five percent less solvent and 26 percent less reactor time compared to the current non-enzymatic and first-generation route.  How is your CDMO contributing towards innovation? Our development team is committed towards incorporating innovation and green technology into our clients’ projects. Our close connections with educational institutes and innovation companies, such as the Health Valley Netherlands — the biggest Dutch life sciences and health innovation network — enables us to build a strong foundation for sustainable innovation.  What ambition does Aspen API pursue? Our efforts provide products that make the lives of people around the world better. It is our duty to develop safe, innovative and sustainable technologies to strengthen our position in the API business.  How do you adapt to the changing business environment? We continuously strive to improve our performance. We demonstrated this during the challenging Covid-19 pandemic, when we continued production and even increased our volumes. Within Aspen, we have a program to organize our work structurally towards our goal of sustainable success. We are also working on new innovative technologies to meet the future needs of the market. When we consider the entire supply chain of pharmaceutical products, API is the crucial beginning and the most critical part of any drug product. Currently, we see a high dependency on countries outside of Europe for key starting materials, components and building blocks for manufacturing vital drug products. The last several years have highlighted the vulnerability of critical manufacturing to supply chain disruptions. The manufacturing of critical APIs in other regions can increase exposure to manufacturing practices that harm the environment. Despite these challenges and constraints, Aspen API has emerged as a major leader in the change to transform, rebuild and position API manufacturing as a critical resource to be managed in an innovative and competitive way. At Aspen, an API is truly more than just an API.    

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    13 Jun 2022
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2023

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    GMP Certificate 2023

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    Green Answer to Peptide Synthesis

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    COMPANY BIO #AboutSupplier

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    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.
    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.
    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.Q1. What is a highly potent API (HPAPI)?Highly potent active pharmaceutical ingredient (HPAPI) is a compo...
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    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.

    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.

    Overview of high potency APIs or HPAPI contract manufacturing services & more on Aspen API's CDMO services for cytotoxic HPAPIs on PharmaCompass.Q1. What is a highly potent API (HPAPI)?Highly potent active pharmaceutical ingredient (HPAPI) is a compound that elicits a biological response at a much smaller dose, such as a daily therapeutic dose of <10 mg. High potency drugs have the ability to bind selectively at low doses to specific receptors or inhibit specific enzymes as part of cancer or hormonal therapies.High-potency APIs (HPAPIs) require multi-step processes or semi-synthesis along with special handling requirements due to toxicity. HPAPI development and production require specialized considerations in facility design, equipment, operation and process safety to achieve the requisite level of containment. It also presents major handling challenges for innovators and manufacturing companies.High-potency APIs (HPAPIs) are becoming increasingly popular and companies are now looking for flexible containment solutions to help address their needs. However, if the current HPAPI development continues to show more efficacy, high potent API is likely to become one of the most dominant areas in the industry. High potency API (HPAPI) is prominent in oncology research and hence represents an increasingly significant share of the pharmaceutical drug pipeline.Because a growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HPAPI) , demand for the production of HPAPIs has increased. Estimates suggest the global HPAPI market will register a strong growth over the next 5-10 years. In addition to cancer, highly potent API (HPAPI) is being used in hormonal imbalance drugs, cardiovascular drugs, central nervous system drugs and musculoskeletal drugs.The challenges in HPAPI manufacturing have also increased, along with investments, in terms of specialized containment areas and procedures to prevent personnel and environmental exposure.  A pharmaceutical CDMO has the capability to offer highly potent small molecule development services and HPAPI Contract Manufacturing Services.Integrated CDMOs have capabilities to offer both production & development services for highly potent APIs (HPAPIs), and to scale-up for HPAPI (highly potent API) development from lab quantities to large-scale volumes. The main advantage of outsourcing HPAPI contract manufacturing services is that it eliminates the need to invest in costly containment infrastructure that can also be difficult to engineer, install and maintain and it can offer HPAPIs, ADCs, highly potent small molecule development services along with manufacturing.Q2. How are the different containment challenges addressed for high-potency APIs (HPAPIs)?HPAPI can be a small-molecule, a biologic, or a hybrid of two molecules, such as an antibody-drug conjugate that links a cytotoxic small molecule to a monoclonal antibody. The cytotoxic nature of highly potent APIs presents significant challenges in terms of safe handling and containment during process scale-up and development, clinical and large-scale production of highly potent APIs (HPAPIs). Hence, HPAPIs require heavy investments for the implementation of specialized containment facilities.Additionally, the cGMP manufacturing of high-potency active pharmaceutical ingredients (HPAPIs) requires an isolated environment that is equipped with isolators and cleanrooms. Working with an experienced pharmaceutical outsourcing organization such as a CMO or CDMO for contract manufacturing of highly potent compounds can help eliminate challenges like investing in expensive infrastructure and the cost of training staff for the production of a highly potent API (HPAPI). Such outsourcing organizations can also offer highly potent intermediates and active pharmaceutical ingredients, ADCs, biologics, large molecule, highly potent small molecule development services along with other contract manufacturing services.HPAPI containment challenges can be handled through the following ways:    A manufacturer of HPAPIs should consider several areas in order to safely manage high potency active pharmaceutical ingredient (HPAPI) processes. For successful HPAPI (highly potent API) development, extensive knowledge and experienced staff are required. Relevant training should be provided to the staff. The training should also feature in-depth information on every step of the handling process, equipment use and unit operations.    Employee exposure to high potent active pharmaceutical ingredients (HPAPIs) is typically the primary concern for manufacturers. As such, it is essential to put a thorough cleaning program in place to avoid contaminating surfaces. If an undesired event occurs, manufacturers of highly potent intermediates and active pharmaceutical ingredients should have a response plan to work from, indicating appropriate reaction from employees to an unplanned incident.    Highly potent active pharmaceutical ingredients (HPAPIs) have a specific occupational exposure limit (OEL) that must be kept in mind to ensure safe handling, as there is a selective process in choosing the most appropriate containment strategy. An occupational physician should work closely with the committee, regulatory authorities and any relevant health and safety bodies. Inadequate containment of high potent API (HPAPI) can decrease product yields or cause cross-contamination of the final product.    One of the largest areas for consideration is equipment. All HPAPI handling and development systems must be tested and verified to meet the necessary isolation requirements while developing and manufacturing high potent active pharmaceutical ingredients (HPAPI). The capability of equipment, systems and procedures to contain and isolate materials under expected operating conditions must be verified as it is a critical component of the overall HPAPI handling and development program.    There must be a close evaluation of the compound for potential toxicity, potency and hazards while developing and manufacturing high potent active pharmaceutical ingredients (HPAPI). By applying rigorous engineering controls within the process scale-up and development, high-quality high potent active pharmaceutical ingredients (HPAPIs) can be produced without adverse effects.    Specialized considerations in facility design, equipment, operation and process scale-up and development as well as safety are needed to achieve the desired level of containment of high potency API (HPAPI) and drug products. It is necessary to carry out a careful assessment of the hazards posed by each product, reagent and intermediate involved in the synthesis before cGMP manufacturing.    To identify the exposure potential, factors including the quantity of material to be handled, the percentage of high potent active pharmaceutical ingredients (HPAPI) and any excipient components, along with the task duration should be considered.Q3. How do contract development and manufacturing organizations (CDMOs) help in the production of HPAPIs?High potency active pharmaceutical ingredient (HPAPI) is a growing area for pharmaceutical manufacturers. Around a third of all drugs in the pharmaceutical pipeline are categorized as high potency active pharmaceutical ingredients (HPAPIs). However, HPAPIs have strict handling requirements that require high capital investment and specialized personnel to develop. Producing ADC, which requires conjugation of a small molecule to a large biomolecule, is even more challenging.Highly potent compounds present numerous challenges in terms of