Time to market determines the commercial success of a product. Everyone wants projects to run like clockwork, with all functions of the business working in synch together, yet keeping to timelines is a major challenge in project management. This is why Boehringer Ingelheim is the partner of choice; its 125 years of experience allows its projects to run smoothly.
Boehringer Ingelheim has a history of successful launches and a long tradition of developing and providing APIs and formulations for its partners. Every facet of its business is specifically geared towards particular projects, so its partner companies profit from from highly efficient project management, making all parts of the projects work together like the gears of a clock.
Chemical production network
The company’s repertoire includes organometallic reactions, lowtemperature reactions, bromination and asymmetric synthesis. It specialises in sugar chemistry, modification of nucleosides and derivatisation of phytochemicals, for which it has a backward-integrated supply chain. Due to the long timelines required for plant-derived material, optimisation of every step saves years and avoids supply shortfalls. Boehringer Ingelheim offers its partners screening for the best botanical source to extract lead molecules. The company provides plants to obtain elite high-content varieties protected by a genetic fingerprint to safeguard its partners’ intellectual property. In vitro culture multiplication allows for rapid generation of large homogenous master pools. HPLC on our farming sites helps to produce low-impurity and high-yield and harvests. Boehringer Ingelheim establishes highly selective extraction processes and cost-efficient, robust purification.
Contract manufacturing
To fine-tune the interdependence between drug substance and drug product, the company offers a range of formulation solutions. The Boehringer Ingelheim site in Columbus, Ohio, in the US, is the global hub for scale-up and launch. This centre of excellence for formulations has a superb track record for speed to market. It takes care of scaling-up, development and validation of analytical methods, overseeing releases, conducting stability studies and compiling registration documents. Its service range covers:
- solids, liquids and nasal suspensions
- from intended final formulation through to launch
- development and validation of analytics to establish final testing specifications
- worldwide supply from the foreign trade zone for the US (TSA-inspected)
- production, storage and shipment of DEA-scheduled drugs
- high containment operations in a dedicated environment
- excellent track record with regulatory authorities.
The company’s projects start with an in-depth analysis by its experts of its partners’ needs. This can comprise:
- establishing worldwide raw material sourcing
- investigating more robust and efficient chemical processes
- eliminating process steps that are cumbersome, especially at larger scale
- completing full characterisation of a partner’s chemical entity with modern analytical methods, to avoid late-stage gaps and surprises
- physical characterisation of a partner’s active pharmaceutical ingredients (polymorphs, particle sizes, fluidity)
- crystal engineering
- cutting-edge equipment, including high-containment facilitie
- meeting the documentation expectations of regulatory authorities without restricting processes
- site master files
- regulatory specialties, such as phytochemicals or controlled substances
- pharmacopoeial activities.
Boehringer Ingelheim typically agrees on roles to be fulfilled by the various facets of its business and agrees with its partners on how these can best complement its partners’ project procedure.
Committed to supporting its partners in the long term, the company offers services from pilot to multi-ton scale within its western chemical production network and in its worldwide pharmaceutical operations.
It also provides a robust manufacturing process that is flexible, quality-focused and efficient. Its ethos of business process excellence goes hand-in-hand with maintaining the highest environmental and safety standards. The company’s aim is to deliver the right product at the right time to the right place. For Boehringer Ingelheim’s partners, this masterpiece of clockwork means perfect timing.