Featured Products & Services
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Formulations For Poorly Soluble And Low Bioavailability Drugs
1/28/2022
Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.
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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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Sterile Formulation Development
7/1/2022
With over 20 years of experience, PCI’s strength lies in our ability to manage products with unique challenges ranging from small molecules presenting with solubility issues or a labile molecule that is only stable as a liquid presentation for a short time.
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Concept Development and DFM
A Blueprint for Success
West believes that getting involved in the very early phases of product development enables the West team of experts to optimize your product design. This philosophy has proven to yield significant short-term and long-term benefits. Getting involved early improves cycle times, identifies the right materials for your specific application, lowers scrap, lowers capital costs and lowers long-term maintenance costs.
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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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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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Pharmaceutical Aseptic Filling Systems For Sterile Injectables
5/25/2021
The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium and low-speed solutions with very high requirements. Our speed range covers till 9.000u/h. In this product range, we can offer maximum benefits like Isolators for high containment solutions, oRAB’s and cRAB's, IPC control with check weighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.
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Assembly Solutions: Medical, Drug Delivery And Diagnostic Devices
Where It All Comes Together
The West Contract Manufacturing team provides quality value-added assembly for almost any medical device, drug delivery device or diagnostic device. West contract manufacturing sites have significant and broad-based experience with assembling these types of specialized products. The team’s experience ranges from multi-component, complex assemblies that are manually assembled to high-speed assembly systems built by some of the world’s leading automation integrators.
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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.
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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.