By PharmaCompass

2022-02-21Impressions: 1626

View Aspen API

View Aspen API's portfolio of various APIs like peptide APIs, HPAPIs, narcotics & biochemical APIs & browse its CDMO services on PharmaCompass.

Q1. What is Aspen API and what services does it offer?

Aspen API is a contract development & manufacturing organization (CDMO) which provides high-quality active pharmaceutical ingredients (APIs) that are used to improve patients' lives worldwide. At Aspen API, your CDMO or CMO API project is in excellent hands. With quality, compliance and collaboration at its core, Aspen API is continuously striving to improve and provide the best solutions to its customers.

Aspen API is well known as a reliable API provider. Its inexhaustible, deep-rooted foundation for complex, powerful APIs has a nearly 100-year-old history. It has a century-long history in developing, up-scaling and commercially manufacturing complex high potency APIs (HPAPIs), peptides, along with narcotics and other established APIs. 

Whether the project is to develop a New Chemical Entity or a process to redesign an (intermediate) API, Aspen API is a suitable partner from the development phase to commercial production. Its facilities have been successfully inspected and approved by regulatory authorities, such as the US FDA, EDQM, PMDA, Dutch Health authorities and PMDA, as well as by its customers. 

Aspen API is an expert in developing, scaling-up and commercially manufacturing complex APIs. It manufactures alkaloids, steroids, carbohydrates, heterocycles, peptides, complex HPAPIs, narcotics, biochemical APIs, anti-coagulation compounds and cytotoxic APIs.

Services Offered by Aspen API:

  • Route selection
  • Process development and optimization
  • Analytical development and validation
  • ICH stability studies
  • Extensive sourcing network for raw materials
  • Global regulatory expertise and support
  • Professional project management

CDMO Services 

  • High potency APIs (HPAPIs)
  • Cytotoxic APIs
  • Peptides (liquid & solid-phase synthesis)
  • Narcotics APIs 
  • Botanical Extraction APIs

Q2. What are the different active pharmaceutical ingredients (APIs) offered by Aspen API?

Aspen API has a long history of serving a stable customer portfolio comprising, among others, multinationals, generic manufacturers and innovative new tech start-up companies. It has established itself as an expert in contract development & manufacturing, process development and optimization, scale-up and commercial manufacturing for complex APIs and complex HPAPIs. 

Aspen API's customers can be sure that they are working with a reliable, high-quality partner. Its CMO cGMP production facilities can produce products from gram to kilo quantities to support clinical and commercial manufacturing. There are several types of APIs offered by Aspen API, such as peptides, high potency APIs (HPAPIs), oncology APIs, steroids, narcotics, botanical extraction APIs, biochemical APIs and cytotoxic APIs.

The different types of APIs offered by Aspen API are:

- Peptide APIs

At its site in Aspen Oss, the Netherlands, Aspen API produces cGMP peptides with batch to batch reproducibility combined with high yields and high-purity profiles. It has extensive know-how and experience in both solution and solid-phase synthesis. Additionally, it has a green method for the large-scale manufacturing of cGMP peptides in solution (GC-LPPS).

Aspen API specializes in complex chemical reactions and is able to develop the most efficient processes. It has developed a patented method for green and large-scale manufacturing of cGMP peptides in a solution which is called Green Continuous Liquid Phase Peptide Synthesis (GC-LPPS). GC-LPPS combines the advantages of the classical liquid phase peptide synthesis with the solid-phase approach.

- High potency APIs (HPAPIs) and Cytotoxic APIs 

Aspen API's strength lies in manufacturing active pharmaceutical ingredients (APIs) at various cGMP production scales with a specialization in high potency APIs (HPAPIs). Its HPAPIs are produced in units with OEB 4 and 5 classifications. Aspen API works with OEL levels as low as 0.01 µg/m³. It is an expert in manufacturing complex HPAPIs (high potency APIs) and cytotoxic APIs.

- Narcotic and analgesic APIs

Aspen API has extensive expertise in manufacturing narcotics and analgesic APIs on a commercial scale according to cGMP (Current Good Manufacturing Practice). It is one of the few UN INCB recognized narcotic manufacturers that complies with the highest standards for API quality.  Aspen API manufactures a vast range of both plant sourced and synthetic analgesic APIs (opioid products) for pain management.

- Botanical extraction APIs

Aspen API is a contract development & manufacturing organization (CDMO) that has extensive expertise in developing and manufacturing botanical extraction APIs on a commercial manufacturing scale according to cGMP. It has dedicated facilities and equipment for the extraction and purification of active pharmaceutical ingredients (APIs) and complies with the highest standards for API quality, traceability and viral safety.

Aspen API is an expert in large-scale extraction and purification of biochemical products, such as heparin sodium and chorionic gonadotrophin, with nearly 100 years of experience. It manufactures oncology APIs vinblastine sulfate and vincristine sulfate from plant sources by unique in-house methods using chromatography. Aspen API manufactures antispasmodic, motion sickness and nausea treatment products Scopolamine N-butyl bromide and Scopolamine base from plant sources using unique high efficiency synthetic chemistry.

- Biochemical APIs

Aspen API's manufacturing processes include validated and approved viral and prion reduction steps. It certifies the absence of bovine, ovine and caprine materials in its heparin sodium through in-house developed and validated real-time PCR analysis technique. It continuously monitors changing governmental regulations throughout the complete value chain.

Q3. Where are Aspen API's manufacturing sites located and what are their regulatory inspections?

Aspen API's facilities are successfully inspected and approved by its customers and regulatory authorities from all over the world, such as the US FDA (Food and Drug Administration), EDQM (European Directorate for the Quality of Medicines & HealthCare), Dutch Health Authorities and PMDA (Pharmaceuticals and Medical Devices Agency). 

Aspen API's compliance standards are extremely high. Its Quality Control Laboratories comply with ICH guidelines - particularly cGMP & ALCOA principles - and are capable of performing all tests to support the customer's entire product range.

Aspen API's Facility Highlights:

- Location: Moleneind, Oss, The Netherlands

Located in the heart of Oss, the Moleneind site carries out numerous activities, including peptide manufacturing, biochemical manufacturing and small-scale chemical manufacturing. The facility has extensive experience and a strong reputation in producing cGMP peptides via solid-phase synthesis and Liquid Phase Synthesis.

Inspection approvals - ANVISA, Dutch HA, KFDA, PMDA, Russian HA, Turkish HA, US FDA.

- Location: De Geer, Oss, The Netherlands

Aspen API's Diosite (De Geer) facility is dedicated to chemical manufacturing. It contains a modern, computer-directed, multi-purpose factory to handle large production campaigns with reaction vessels up to 10,000 liters. The facility also carries out sieving, milling and micronisation of the APIs and manages the central warehousing and distribution operations.

Inspection approvals - ANVISA, Dutch HA, KFDA, PMDA, Russian HA, Turkish HA, US FDA.

- Location: Boxtel, The Netherlands

Aspen API runs a biochemical operation in Boxtel. This dedicated facility collects urine from pregnant women and further processes it to produce the API, Human chorionic gonadotropin (hCG). 

Inspection approvals - Dutch HA, PMDA, Russian HA, Turkish HA, US FDA.

- Location: Sioux City, Iowa, USA

At its Sioux City (Iowa, USA) facility, Aspen API collects porcine mucosa and produces a crude heparin. This crude heparin is then transported to its facilities in Oss for final purification and product release. The Sioux City-based facility is located in an important livestock area in the USA, providing the company  access to many large slaughterhouses, and thus to large mucosa quantities. 

Inspection approvals - US FDA

- Fine Chemicals Corporation, Cape Town, South Africa

Fine Chemicals Corporation is a wholly owned Aspen subsidiary which is located in Cape Town, South Africa. The facility has 10 production buildings. The total cGMP production processing area is 6,965 m2.

Inspection approvals - US FDA, PMDA, TGA, SAHPRA, EDQM/ANSM

Q4. What are some of the key technologies of Aspen API?

Aspen API is a contract development & manufacturing organization (CDMO) which develops and manufactures steroids, complex APIs and complex HPAPIs. Its CMO cGMP production facilities are capable of producing products from gram to kilo quantities and supports clinical and commercial manufacturing needs of its customers. With its competencies and technology platform, Aspen API adds powerful value to customers' contract development & manufacturing goals. It also carries out a wide variety of (complex) chemical reactions, along with process development and optimization. 

Here is a list of its technology platform.

At Aspen Oss B.V., the Netherlands:

  • Lithium aluminum hydride & sodium borohydride reduction
  • Liquid ammonia reduction
  • Peptide Solid-phase Synthesis and liquid phase peptide synthesis
  • Catalytic hydrogenation
  • Preparative HPLC
  • Bromination Ethynylation
  • Oxidation 
  • Grignard

At Fine Chemicals Corporation, South Africa:

  • Catalytic hydrogenation
  • Heteroatom acylation
  • Heteroatom and carbon alkylation
  • Hofmann degradation
  • Hydride reduction
  • Phase transfer reactions
  • Racemic resolution
  • Chlorination
  • Oxidation
  • Preparative HPLC

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Image Credit : Biosynthesis, tech advancements by PharmaCompass is licensed under CC BY 2.0

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