Coherus BioSciences has been granted a patent for a novel method of providing sterile, pre-filled syringes or 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 use in 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 September 2023 was 31%. 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 granted patent (Publication Number: US11752225B2) describes a method for providing a sterile, pre-filled injection device in an aseptic environment. The method involves several steps, including introducing a sterile device body, plunger, and plunger rod into the aseptic environment, filling the device body with a sterile ophthalmic pharmaceutical composition, stoppering the filled device body with the plunger and plunger rod, and packaging and sealing the device into sterile packaging.

The method also includes options for sterilizing the ophthalmic pharmaceutical composition, such as passing it through an in-line sterile filter with a pore size of 0.22 micron or less. The packaging can be thermoformed in the aseptic environment or sterilized separately before being introduced into the environment.

The aseptic environment is described as a sterile processing facility with a positive pressure air filtration system. The method emphasizes the use of clean and sterile garments by the workers involved in the process, which can be disposable or sterilized between uses. The garments are made of synthetic fabric, such as polyester, Teflon laminated fabric, or Tyvek, and possess qualities like non-linting, anti-static, chemical resistance, non-flammability, and liquid-proof.

The patent also mentions the use of a cap on the syringe before filling, the inclusion of VEGF antagonists in the pharmaceutical composition, and different methods of sterilizing the device body, plunger, and plunger rod, such as treatment with ethylene oxide, steam, or radiation.

The packaging options include blister packaging or pouches, and the sterile processing facility can be a Restricted Access Barrier System or an isolator with specific ISO ratings.

The patent also describes a method for validating the procedure for producing multiple batches of the sterile, pre-filled injection devices. This includes continuous air monitoring, surface swab and touch plate testing, re-validation activities on process and equipment, annual media fills, and sterility testing of each product batch.

Overall, this patent provides a detailed method for producing aseptically-packaged sterile, pre-filled injection devices in a controlled and sterile environment, ensuring the safety and efficacy of the pharmaceutical composition.

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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