Abbvie Contract MFG

  Aseptic processing is a production method that can manufacture products that do not have bacteria or other contamination without subjecting the product to terminal sterilization processes. Several products degrade and lose their effect when subjected to the tough conditions of terminal sterilization. Aseptic process manufacturing permits these products to be manufactured in a sterile environment, letting them maintain their usefulness while being safe to use on humans. This article talks about the fundamentals of aseptic processing. Continue reading to learn more. At AbbVie, we are number one when it comes to fill finish manufacturing . We deal on all kinds of pharmaceutical fill finish. The Importance of Establishing Environment Controls for the Aseptic Process All drug manufacturing, including terminal sterilization and solid oral dose manufacturing, must have environmental controls. This condition is addressed in cGMPs (Global Current Good Manufacturing Practices.) The aim of ...

  For drug manufacturers working on injectable medication, getting a new molecule to the clinic effectively and quickly is crucial; however, getting there with a safe product supply is also essential. Filling batches of clinical trial material is an important step in this process. Attention to a few major areas of this crucial pharmaceutical fill finish project can help prepare it for success. Filling Clinical Trial Material Before now, drug manufacturers spent quality time developing their molecules in a laboratory, manufacturing small volumes. In this phase of nurturing, the center is on understanding the molecule. However, two challenges are significant when it comes to in-human trial: developing a highly scalable, quality filling process that meets all quality and safety requirements and manufacturing significantly larger volumes to support a trial for in-human use. The Four Steps Involved Below are the four steps required in the preparation of medicine fill finish for clinica...

  Extrusion is the procedure involved in changing the physical properties of a substance by forcing it through a die or an orifice under controlled conditions. The equipment used in this process is classified into three major categories: screw extruders, radial screens, and ram. However, screw extruders are the most essential in the pharmaceutical industry. They are the most important because they constantly convert feed material to the finished form such as film, tube, or rod. Continue reading this blog to learn more about screw extruders as one of the equipment used in the process of proprietary hot melt extrusion .   Screw Extruders Pharmaceutical screw extruders are manufactured based on the desired extrudate. They are needed to meet the present regulatory standards for the production of dosage forms. They are categorized as: * Single-screw extruders * Twin-screw extruders * Multi-screw extruders Regardless of the type, process complexity, or function, the different extrud...

Hot melt extrusion is the act of introducing pressure and heat to dissolve a polymer and make it go through an orifice in an ongoing process. Hot melt extrusion is a well-known processing method for polymers as far back as the thirties. With the evolution of technology, hot melt extrusion has found use in the healthcare industry, where it is used in many applications. In this blog, we shall highlight the uses of proprietary hot melt extrusion in the pharmaceutical industry. Continue reading to learn more.   The Uses of Proprietary Hot Melt Extrusion There are two most common reasons for using hot melt extrusion in the pharmaceutical world, highlighted and discussed below; 1. HME is Used to Improve the Bioavailability and Solubility of an API For BCS class II and IV active pharmaceutical ingredients, poor solubility is a result of a steady crystalline form that cannot be penetrated by water. The amorphous form of an active pharmaceutical ingredient is usually more soluble because ...

The highly- potent drug contract manufacturing industry continues to grow annually. The market for HPAPIs (highly potent active pharmaceutical ingredients), such as prostaglandins, anti-cancer drugs, opioids, and hormones, has a very high value. Producing highly potent compounds involves extremely intricate, pricey facilities and processes. The compounds also come with high risks of contamination and toxicity. Because of these concerns, many pharmaceutical companies are partnering with contract manufacturing organizations. However, partnering with CMOs isn’t all it takes; finding the right expertise is the most important. Handling Highly Potent Active Pharmaceutical Ingredients Handling high potency active pharmaceutical ingredient formulations requires excellent and meticulous attention to detail, outstanding training, and a great understanding of the risks at every step of the manufacturing process. This means that pharmaceutical manufacturing companies must take extreme care when c...

  Hot melt extrusion(HME) services have evolved as a unique processing technology in producing molecular dispersions of active pharmaceutical ingredients (APIs) into various polymer or/and lipid matrices, which has led to time-regulated, modified, extended, and targeted drug delivery. HME now allows us to use compounds to conceal the bitter taste of active drugs. Since the industrial application of the extrusion process in the 1930s, proprietary hot melt extrusion has gotten a lot of attention from the pharmaceutical industry and academia for a variety of applications for pharmaceutical dosage forms like tablets, capsules, films, and implants for drug delivery via oral, transdermal, and transmucosal routes. As a result, HME services are an ideal alternative to other commonly used processes such as roll spinning and spray drying which we make use of at Abbvie Contract Manufacturing. In addition to being a tried-and-true manufacturing process, meets the goal of the US Food and Drug...

  A continuous process of melting a polymer under pressure and heat and forcing it through an aperture is known as hot melt extrusion (HME). We largely use Proprietary hot-melt extrusion at Abbvie Manufacturing. Known for being created to create polymer goods with uniform shape and density, proprietary hot-melt extrusion has been used in industry since the 1930s. We have some fun facts for you below about hot-melt extrusion 1. More than half of all plastic goods, such as bags, films, sheets, tubes, fibres, foams, and pipes, are prepared using this technology, which is one of the most commonly utilized in plastic, rubber, and food industries. 2. HME is now more commonly employed in the healthcare sector, where it is combined with polymers to create medical devices and combine active pharmaceutical ingredients (APIs) with them 3. Hot-melt extrusion services are utilized to increase the bioavailability of the API or to create the building blocks for thermoplastic drug-eluting devices...