Coherus BioSciences has filed a patent for a novel method of providing sterile, pre-filled injection devices for pharmaceutical compositions, including protein and biopharmaceutical formulations. The method involves performing secondary packaging in an aseptic environment, eliminating the need for terminal sterilization. The resulting injection device is suitable for ophthalmic injections. GlobalData’s report on Coherus BioSciences gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Coherus BioSciences, peptide nano-particle conjugates was a key innovation area identified from patents. Coherus BioSciences's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.

Aseptic packaging method for sterile pre-filled injection devices

Source: United States Patent and Trademark Office(USPTO). Credit: Coherus BioSciences Inc

A recently filed patent (Publication Number: US20230201387A1) describes a method for providing a sterile, pre-filled injection device in an aseptic environment. The method involves introducing a sterile device body, plunger, and plunger rod into the aseptic environment. Then, a sterile ophthalmic pharmaceutical composition is either introduced into the environment or sterilized within it. The sterile device body is filled with the sterile pharmaceutical composition to create a sterile filled device body. The device body is then stoppered with the sterile plunger and plunger rod to form a sterile stoppered pre-filled injection device. Finally, the device is packaged and sealed in the aseptic environment to produce the aseptically packaged sterile pre-filled injection device.

The patent also includes additional claims and methods related to the process. These include using thermoformed packaging in the aseptic environment, sterilizing the packaging before introducing it into the environment, passing the pharmaceutical composition through a sterile filter during sterilization, performing the packaging and sealing step directly after the stoppering step, and using a clean and sterile garment during the process. The patent also mentions the use of specific materials for the garment, such as synthetic fabrics made from non-woven filaments.

Furthermore, the patent describes a method for reproducibly validating the procedure for producing multiple batches of the aseptically packaged sterile pre-filled injection devices. This includes steps such as continuous air monitoring, surface swab and touch plate testing, re-validation activities, annual media fills, and sterility testing.

Overall, this patent outlines a detailed method for producing aseptically packaged sterile pre-filled injection devices in a controlled and sterile environment. The method includes various steps and considerations to ensure the sterility and quality of the final product.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies