Featured Products & Services
-
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.
-
Pharmaceutical Development
4/24/2023
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
-
Pharmaceutical Vial Filling Equipment: VFM
4/28/2021
VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
-
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.
-
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.
-
Liquid Filling And Packaging System For Pharmaceutical Injectable Products
10/29/2019
ASEP-TECH® Blow/Fill/Seal systems are ideally suited for packaging injectable products, including small-volume and large-volume parenterals. Containers are formed, filled, and sealed in one compact machine frame, eliminating many of the steps and additional expenses of conventional processing. Blow/Fill/Seal containers offer tremendous advantages over glass, including weight savings, particle-free processing, resistance to breakage, ease of opening, and recycling capability.
-
A User-Friendly Solution For Fill-Finish Professionals
1/31/2024
When AST came to the table on the design for our new fill-finish isolator, one of the first areas AST engineers wanted to address was the usability and accessibility of the isolator and corresponding operations. With our customers’ point of view in mind, we wanted to address specific points of friction routinely encountered by operators and closely examine whether those friction points were necessary.
Does an isolator need to be ergonomically unfriendly to clean?
Should simple mechanisms like isolator doors be challenging to engage? (As much as one can appreciate exercise, no one wants to do “arm day” in cleanroom coveralls).
Does routine maintenance have to be time-consuming and laborious?
Many of these factors are accepted as par for the course in aseptic fill-finish manufacturing. Our question was, why?
-
ASEPTiCell® - 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.
-
Single Dose Blow/Fill/Seal Pharmaceutical Vials
5/26/2017
Unit dose blow/fill/seal vials for one-time ophthalmic use have become an accepted international standard for pharmaceutical manufacturing and packaging. The ASEP-TECH Advantage is reflected in the development of formulations that no longer contain preservatives, minimizing the risk of allergic reactions for patients.
-
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.