Featured Products & Services
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Robotic Multi-Format Filling & Closing System
1/2/2020
AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.
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Injection Molding
8/24/2020
Capabilities that improve efficiency and accelerate development.
B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.
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Nasal Dosage Form Development
10/23/2024
Upperton have developed UpperNose™, a nasal product development approach designed to streamline the development process for nasal dosage forms.
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Aseptic Filling System For Pharmaceuticals: BI-MI
2/16/2021
Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.
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Rapid Development Through Phase I CTM
1/28/2022
Ascendia works with discovery-stage pharmaceutical companies to provide lab-scale formulations suitable for pre-clinical testing. We conduct pre-formulation assessments, bioavailability modeling, and formulation approach comparisons. We provide trial formulations suitable for animal studies, toxicology studies, and cGMP clinical trial materials for Phase I studies.
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A Breakthrough Solution For Biologics
8/25/2023
Medicines are highly sensitive to primary packaging components, which can affect compatibility with container closure systems. Discover Alba® syringes, designed for sensitive biologics, including highly concentrated drugs vulnerable to silicone interaction and ophthalmic medications.
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Pharmaceutical Vial Filling Machine With Isolator
5/3/2023
Rotary filler for clinical and early-stage pharma production specialized for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.
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Bionanoparticle Technology
4/24/2023
Nanoform’s proprietary bionanoparticle technology can deliver large-molecule drug particles as small as 50 nm while retaining biological activity. This can not only enable more patient-friendly approaches to drug delivery, but also potentially higher loads of active ingredients.
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Aseptic Filling Systems For Biopharmaceutical Manufacturing
3/28/2023
AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.
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cGMP Aseptic Manufacturing And Sterile Fill-Finish
1/28/2022
Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.