Abbvie Contract MFG

  Producing Biologic Drugs with Sterile Fill Finish Choosing a sterilization tactic for a drug product that needs aseptic fill finish production is commonly determined by the drug substance stability. For terminal sterilization, stable products that include heat sterilization exposure to chemicals like vaporous hydrogen peroxide and ethylene oxide or radiation is the preferred strategy. These methods have advantages. This is because the processes can be tracked and validated and are less susceptible to error. However, most biologic drugs are not stable when exposed to chemicals, radiation, or heat, and they usually require aseptic fill finish manufacturing with the use of sterile filtration. A successful sterile filtration demands a drug product formulation with the right viscosity and compatibility with the shear stresses involved in fluid pumping and the contact surfaces. Today, single-use technology is vastly used in sterile fill-finish operations. And it helps to reduce the c...

  Investment and Flexibility for Effective Production of Fill-Finish The global biopharmaceutical industry is expected to experience fast growth within the next decade. In preparation for this demand, pharmaceutical manufacturers are investing greatly in cutting-edge aseptic fill-finish technologies. This is done to increase production efficacy and efficiency. Creating new methods of development informs new sets of challenges. This is why it is beneficial to partner with an industry leader in medicine fill finish , as it is key to guaranteeing and achieving success.   Methods of Fill-Finish Sterilization In keeping up with the growth in this industry, manufacturers are required to continuously respond to and abide by the rigid packaging and handling regulatory demands of the production of biologics. The United States Food and Drug Administration has formally mandated that every piece of equipment used in biomanufacturing must pass through sterilization before it reaches t...

  Considerations for Aseptic Processing and Sterile Fill-Finish Sterile injectables such as liquids filled in vials are the first drug products that come to mind when the term “sterile fill-finish ” is mentioned. While suspensions, emulsions, and liquid solutions are very common candidates for sterile fill-finish operations, lyophilization and powder fills are equally performed under aseptic conditions.  At AbbVie, the nature of your biologic drug notwithstanding, you can count on us when it comes to aseptic fill-finish manufacturing. We will provide reliable, safe, and ready to use products.  Every individual component of a drug product must pass through the sterilization process before aseptic processing. This includes water for injection (WFI), active pharmaceutical ingredients (APIs), and any other excipients involved in a formulation. Some FDA-recommended methods to sterilize components include the following:  ●Radiation Sterilization This is a method where a co...

  Why is the Aseptic Processing Challenging? We may not realize it, but every person in the universe could be affected by the usage of sterile products. This can include the use of lifesaving prescription drugs like Epinephrine or Insulin, needles to inject vaccines, the insertion of ventilator tubes to help patients breathe, as seen in 2020 during the COVID-19. In general, aseptic fill-finish can affect every single person in the world. At AbbVie, we have successfully advanced and distributed drug products for over 130 years, delivering products to more than 175 countries globally. There is no basis for the question as to whether or not we are excellent at what we do.  Our article has highlighted some of the challenges in Aseptic Processing. Continue reading to learn more about them.   1. The first opposition in aseptic processing is the facility where the fill-finish manufacturing occurs or where the products are generally being produced. The facility needs to be cons...