Aenova HPAPI Brochure

Aenova, one of the world's leading Contract Development and Manufacturing Organizations (CDMO) expands its offering for the development and manufacturing of high-potent active pharmaceutical ingredients at its Regensburg site. Aenova thus provides its customers with doubled capacities for laboratory and manufacturing and strengthened its development services for innovative APIs including pre-formulation services.

We go beyond manufacturing with a commitment to quality and reliability that is anchored in everything we do. Scientific expertise, innovative technology platforms and a strong customer focus make us the one-stop-shop of choice.

Aenova, one of the world's leading CDMOs (Contract Development and Manufacturing Organizations) for the pharmaceutical and healthcare industries, is implementing a new gummy line at its site in Cornu, Romania. Gummies are quickly emerging as the dosage form of choice for many food supplements and even pharmaceutical applications. The new gummy line will be launched by the end of 2024 with a capacity of approximately 1 billion gummies per year.

Aa a leading global contract manufacturer and development service provider with 14 production sites in Europe and the USA, we offer extensive capabilities for Steriles, Semi-Solids, Solids and Packaging. 

Cannabinoids can provide great benefits for the treatment of cancer and central nervous system diseases. Softgel capsules are the preferred delivery form for cannabinoid products for many reasons. Aenova presents this in the new white paper "Cannabinoids: Therapeutic effects and the advantages of soft capsules as appropriate dosage form".

One of the biggest challenges in pharmaceutical research and development is to complete development projects as quickly as possible. More and more drugs fall into the category of 'unmet medical need' and therefore qualify for accelerated approval. But developers need time to optimise the formulation of the sensitive or highly potent compounds that dominate the current pipeline of drug candidates.Finding the right balance between speed and thoroughness is a challenge. But it can be solved by choosing microdosing technology in capsules. Manufacturers can dose small amounts of pure active pharmaceutical ingredients (APIs) or mixtures directly into hard capsules. Microdosing of less than 5 mg or low doses of 5 mg to 100 mg in hard capsules is a good option that allows manufacturers to get new drugs into research and development or onto the market faster.The direct, precise and reliable filling of low-dose hard capsules can be scaled up in an industrial process. 

Aenova offers over 20 years of experience and the full services of 7 approvedmanufacturing sites. This enables us to provide excellent end-to-end services fromdevelopment to packaging for a wide range of medicines for companion animals and livestock.

Low aqueous drug solubility in pharmaceutical development is a recurring issue. The softgel capsule offers many possibilities in the development of new drugs, especially when it comes to solubility and bioavailability enhancement. In the current white paper, experts from Aenova explain the challenges of softgel capsules in development and commercial production, particularly considering the complexity of softgel production technology, as well as the suitability of the softgel capsule as an appropriate dosage form for certain areas of application.

Explore the transformative potential of softgel capsule technology with the new Aenova white paper.

This white paper delves into the intricacies of developing and producing softgel capsules, highlighting the advantages they provide in drug formulation, including improved stability, patient-friendly administration, and precise dosing.

Gummies are fast becoming the dosage form of choice for manyfood supplements and even pharmaceutical applications.The global Gummy supplements market has reached a value ofover $9 bn in 2023 and is anticipated to grow to $18.2 bn by 2033.1

HPAPIs (highly potent active pharmaceutical ingredients), provide precision treatment for cancer, autoimmune disorders, infectious diseases, and other medical conditions. Their safe handling is a challenge for drug manufacturers, who have to meet equipment, environmental and product quality requirements in the production and development of HPAPIs.

Jan Kengelbach, CEO of Aenova, discusses how the company’s partnership with Kühne Holding AG, its focus on capacity, innovation, and flexibility, and its strategic growth plans position it as a leading partner in the CDMO sector. He also shares insights on Aenova’s approach to evolving industry trends and attracting top talent.

High-potent drug products for oncology or hormone therapy will play an important role in innovative drug therapy in the future. The development and production of drugs with high-potent active ingredients is highly complex and often must be implemented with acceleration. Handling of high potent solid dosage forms therefore is a key need of current pharmaceutical development and manufacturing. To ensure safe and efficient handling of high potency products, mastering a holistic production approach is essential. This drives a fast time-to-market for your new high potent product. 
 

Aenova is a leading contract development and manufacturing organization (CDMO) for the pharmaceutical and healthcare industry worldwide. The range of services covers the entire value chain of development and production of all common dosage forms (solid, semi-solid and liquid, sterile and non-sterile; high potency and low dosage) and product groups in drugs and food supplements for human and animal health.  Aenova offers its customers full service, ranging from product development to the purchase of raw materials, production, analytics, market release. Aenova develops, produces and packages at 15 locations in Europe and USA. Around 4,500 employees contribute to the success of Aenova. www.aenova-group.com 

Aenova CPHI BCN 2023

Aenova CPHI BCN 2023 (PART 2)

Aenova CPHI BCN 2023 (PART 3)

Jan Kengelbach, CEO of Aenova, talks about three key elements of how Aenova enables its customers to grow their business.