Pfanstiehl’s has continually committed to producing the industry’s highest purity, lowest endotoxin, lowest metal, platform-enabling protein and cell membrane stabilizers which include Trehalose, Sucrose and the newly launched Arginine, Mannitol and Sodium Succinate. These products are produced in our ICH Q7-compliant manufacturing facility in the U.S. and have market leading specifications which include ICH Q3D Elemental Impurity Data. Pfanstiehl is significantly expanding its products and solutions portfolio in 2018 and beyond to include other key excipients based on feedback from our clients.
As we are entering into a new era of increased regulatory scrutiny, Pfanstiehl’s Know Your Products & Processes Program, has resulted in product characterization data that enables us to stay ahead of new regulatory requirements. We offer full product characterization data to our clients free of charge, understanding the criticality of such information. This shows our commitment to our clients and their success, as we deliver World Class Levels of Quality and Consistency.
We offer full product characterization data to our clients free of charge, understanding the criticality of such information.
For upstream applications, Pfanstiehl manufactures and recently launched a new high purity, low endotoxin, low metal D-Galactose. Galactose is a key component in cell culture media, which helps to optimize protein production while mitigating lactate and ammonia formation. Galactose is used as a cell metabolism modulator and helps to increase yields, which is why Galactose utilization is growing in our biopharmaceutical market. Pfanstiehl has implemented specifications for the new Galactose to recognize a tighter control strategy, which provides product consistency and better support for biopharmaceutical upstream processing requirements. The specification will exceed regulatory requirements and reflects Pfanstiehl’s leadership in setting the industry standards with our high purity, low endotoxin, low metal Excipient products and solutions. Complimentary samples from Pfanstiehl’s cGMP validation batches of Galactose are available for customer qualification activities, along with a Product Profile and extensive product characterization data. Trehalose can also be utilized in upstream bioprocessing and cell therapy applications to reduce protein aggregation and improve cell robustness.
Pfanstiehl is also a cGMP Contract Development and Manufacturing Organization (CDMO) specializing in the isolation, purification, custom synthesis and scale-up development of small molecule High Potency Active Pharmaceutical Ingredients and Active Pharmaceutical Ingredients. Pfanstiehl has recently completed upgrades to our API manufacturing operations and can produce grams to multi-ton commercial quantities. We specialize in carbohydrates, nucleosides, and New Chemical Entities (NCEs). With over 50 years of experience in custom synthesis and process development under cGMP guidelines, we are uniquely qualified to move new compounds from the laboratory to the commercial marketplace.
Pfanstiehl also manufactures generic API’s such as Streptozotocin and has several new products under development. In addition, Pfanstiehl offers large volume parenterals, including Sodium and Ammonium Lactates, manufactured right here in the Unites States. These products are also high purity, and have low endotoxin and low metals for parenteral grade injection, with DMF support in the US and around the world.
The BRC regulates the compaction energy and slug thickness in an innovative way and generates a consistent compacting of the material throughout a range of < 1 - 400 kg/h. Meanwhile, the advanced design of the unit simplifies handling and shortens the fitting procedure.
The “Hygenic Design” and already as standard integrated washing nozzles guarantee an effective WIP process with a residue-free removal of the product. The compactor also meets “Quality by Design” requirements with its functional GMP-tailored construction and the option of implementing PAT-tools.
Besides influencing the compacting energy of the unit, the milling step has a substantial impact on the particle size of the granule. Milling the slugs into a granule with the desired range of particle dimensions is performed by the conical Bohle Conical Mill (BTS) and sieve inserts with very little waste – even at a high throughput rate. Every BRC can be re-fitted in a matter of minutes to serve as an alternative rotational sieve and adapted flexibly to the process and slug conditions.
An important and substantial advantage of roller compactors is their small footprint and easy integration into the production process. Bohle has installed numerous BRC units in various production scenarios (stand-alone unit, wall installments, stage and multi-floor applications as well as individual containment applications) working with both batch and continuous manufacturing concepts.