Hänseler
A Swiss Specialist in Product Transfers in Different Galenic Forms

Bringing galenic formulations successfully to market requires a blend of scientific expertise and operational excellence. Hänseler Swiss Pharma, a Swiss contract development and manufacturing organization (CDMO), leads in offering comprehensive development and manufacturing solutions to streamline the path to market success for their clients.

Optimising production processes for efficiency and quality and rapidly scaling operations to meet market and regulatory demands can be significant hurdles. Even companies with vast experience struggle with the challenges of navigating to the right CDMO in order to keep their products alive in the market.

Showcasing a proven track record in this arena, Hänseler’s expertise encompasses a wide range of dosage forms, including solids and semi-solids, with a particular proficiency in liquid formulations. It focuses on mid-sized production volumes to ensure high-quality products paired with a touch of customisability for its clients.

“In order to fulfill our clients’ expectations, regulatory and analytical topics are as important as the production process itself,” says Michael Jäger-Rhomberg, CSMO.

Roots in the pharmaceutical sector cultivated Hänseler’s direct link with nearly every pharmacy and drugstore in Switzerland. Over the years, it has operated as a contract manufacturing organization on a small scale and developed a diverse product range catering to the specific needs of clients. Transitioning into an industrial CDMO over the years, it now targets specific pharmaceutical industry sectors to produce chemical solution APIs or excipients such as sodium chloride solution, Triethylammonium acetate solution or Hydrochloric acid solution.

Conceptualizing with the client

Hänseler’s expertise in chemical engineering, biological sciences and phytochemical compounds fuels the contract manufacturing of specialised drugs and medications. Typically, clients bring their concepts or ideas, and in the discussions that follow, Hänseler provides tailored solutions to ensure the best possible development and manufacturing experience. This collaborative approach ensures that the final product always meets clients’ goals in the desired specifications and quality standards.

Partnerships often begin with a small-scale transfer that enables clients to assess the quality and trustworthiness of the manufacturing process. It is expanded to include complete and reliable project transfers as confidence builds. Hänseler often takes over the entire production process unless the clients states otherwise. This includes handling validation batches, stability testing, commercial production and process validations, ensuring a seamless transition and production cycle. Nevertheless, some clients do not want to provide the recipe necessary to manufacture the product, so they deliver the bulk for refill and packaging.

“It is always about partnership: Building trust through engagement, loyalty, service and quality needs time,” says Jäger-Rhomberg.

Satisfactory analytics trigger the initiation of the regulatory transfer process, requiring the compilation and delivery of all necessary documentation—a critical aspect increasingly requested by pharmaceutical regulatory authorities. Upon regulatory approval, the transfer is completed, leading into commercial production.

Planned or urged CMO-Transfers are in demand

Hänseler has gained great expertise in conducting time-critical CMO transfers, particularly when US companies need to maintain market share after losing FDA audits. Hänseler is FDA-audited and GMP/GDP certified. We still see an increasing demand of cosmetic and food supplement clients who are seeking GMP-certified CMOs. Others drop their own GMP-certification to reduce costs. Another common case is the outsourcing of filling or packaging, as clients tend to outsource these tasks to keep recipe knowledge inhouse.

Hänseler recently completed a project involving a muscle relief cream. The client, a registered drug product manufacturer, needed approximately 100,000 filled aluminium tubes. Hänseler transferred the production method seamlessly, developed stability plans and conducted manufacturing and process validation to ensure quality and compliance with regulatory standards. From planning and sourcing, followed by laboratory testing to verify the specifications of raw materials and the finished product, it expertly handled the entire operation. This successful product transfer followed by expert project execution demonstrated Hänseler’s ability to scale production efficiently, leverage its network and handle diverse materials adeptly.

Sourcing services through a comprehensive global network ensure the availability of raw materials needed for bulk manufacturing. Hänseler works with a diverse range of materials, including chemical solids, narcotics, essential oils, vitamins and herbs, contributing to an extensive knowledge base that is utilised to scale up production for industrial partners.

The aim is to source together, working with clients and allowing them to choose from its extensive portfolio of products and ingredients from trusted partners, or leverage their existing partnerships. It can also assist in sourcing novel products or ingredients by identifying and securing new suppliers. This dynamic approach is part of its full-service offering.

Cutting-edge technology for scalable production

Hänseler’s production process is rooted in its robust infrastructure. A range of specialised machinery is used to manufacture various galenic formulations. It employs homogenisation tanks capable of inert-processing liquids. The oxygen in the tanks is mixed with nitrogen by pumping it up several times. Subsequent degassing minimizes the oxygen content in the tanks so that the product cannot oxidize. It also allows to safely handle flammable liquids. This includes two new, 12,000-liter tanks that are fully integrated with advanced technology for more efficient bulk production, process validation and cleaning, demonstrating a capability to handle diverse production requirements. They are particularly suitable for the production of aqueous and ethanolic solutions such as various tinctures and extracts.

The distillation systems, ranging from 100 to 500 litres, complies with regulatory standards and feature integrated reactor temperature sensors and pressure measurement probes for precise operation. A closed system employed for its cleaning-in-place process ensures reliability and is fully compliant with regulatory standards.

To complement its formulation and production capabilities, Hänseler offers comprehensive packaging solutions. These include leaflet insertion and packaging in various containers such as bottles, aluminium tubes, or plastic tubes and can accommodate volumes ranging from 10 millilitres to 1 litre. The company recently invested in a new filling and closing machine, scheduled to be operational soon, which will significantly enhance its packaging production capabilities and scalability.

An in-house laboratory conducts most analyses, while specialised processes are outsourced to trusted external partners.

The collective knowledge of its team fuels the company’s versatility. Drawing on diverse expertise and experience, the team excels in comprehending and addressing customer needs across various domains. Experienced crews in manufacturing, packaging, sales and marketing deliver tailored solutions to meet client needs. Additional expertise is brought in as required for specialised areas like phyto products or narcotics. Each project is carefully structured with dedicated project leads overseeing every stage.

Swiss pharma market experts

Market access is one of Hänseler’s most valued service, facilitated by its extensive background in the Swiss pharma sector. Companies looking to enter the Swiss market may find it challenging to find a foothold due to its underlying characteristics and registration processes. “Establishing own entities in Switzerland may not be cost efficient for many companies due to the market’s limited size,” says Michael Jäger-Rhomberg.

Establishing own entities in switzerland may not be cost efficient for many companies due to the market’s limited size

Hänseler is a reliable and established presence that offers an attractive partnership. Nearly every pharmacy in Switzerland is a retail partner of the company, demonstrating almost 100 per cent market penetration. It collaborates with major pharmacy chains and groups, using key account management strategies and robust market channels, including a comprehensive client database through a B2B web shop where pharmacies can conveniently order products. The platform allows Hänseler to efficiently introduce new products, active pharmaceutical ingredients and excipients in response to market demand.

Hänseler also attracts partners facing GMP compliance challenges or those looking to enter new markets in the U.S., where FDA approval is required. Its recent success in the FDA audit has attracted more clients in need of this specialised service.

In the near future, Hänseler aims to expand its business by becoming the exclusive distributor of numerous products in Switzerland. For instance, it already has private distribution agreements with a prominent German supplier of essential oils.

In transforming ideas into market success, Hänseler positions itself as a trusted partner for companies, ensuring scientific expertise is seamlessly translated into high-quality, market-ready products.