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Showing posts from December, 2020

Challenges Manufacturers Encounter During Aseptic Fill Finishing

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  Challenges Manufacturers Encounter During Aseptic Fill Finishing Aseptic fill finishing can be quite challenging, as asepsis techniques involve procedures that eliminate harmful spores, pathogens, parasites, viruses, and fungi. These procedures require careful planning from thoroughly trained personnel. The facilities and equipment used for this procedure are specialized and require expert care and handling. Any errors encountered during any of the drug development processes, storage, and transportation can affect how safe and efficacious the drugs are. Here are four of the most common challenges manufacturers face during fill finishing manufacturing . Four Challenges Encountered 1.Protein Structure and Stability When it comes to the manufacturing of protein-based drugs for large scale commercialization, many factors need to be considered. Different process parameters come into play when dealing with the production of drugs, from processing to storage and transportation. Each of ...

Three Things Every Drug Manufacturer Should Have in Place Before Personally Handling their Fill Finish

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  Three Things Every Drug Manufacturer Should Have in Place Before Personally Handling their Fill Finish Fill finish is the last and arguably the most important stage in drug manufacturing. In layman's terms, fill finish refers to transferring a sterile drug from a sterile needle to a sterile container. This is a crucial part of the entire biopharmaceutical manufacturing process.  Fill finish is a common bottleneck in the manufacturing process; that's why manufacturers look to partner with a reliable third-party provider. However, the challenge is in choosing the right partner; we're here to make that decision a lot easier to make. Three Criteria That Should be in Place Before Any Fill Finish Process is Initiated Industry Standard Procedures In the pharmaceutical space, tried and true industry practices should always be the topmost priority; this should be your core message. Whether you’re choosing a third-party provider to contract your fill finish manufacturing or you ho...

Fill and Finish Cell Therapy

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  Fill and Finish Cell Therapy Abbvie Contract Manufacturing has the leading experts and a global network to scale-up and scale-out drug fill-finish , allogeneic and autologous therapies. Our cGMP manufacturing services deliver excellent operations, customer satisfaction, and future vision for your therapeutic product. Our state-of-the-art CGMP facilities are both FDA and EMA compliant, offering flexibility and confidence in manufacturing at a worldwide scale. Our expert development and manufacturing teams are sophisticated, and we partner with our gene therapy teams for viral vector production. This brings your cell therapy product from development to industrialization in a seamless process. Each facility has commercial manufacturing, clinical, and development operations offering full-service capabilities for our client needs. At Abbvie Contract Manufacturing, we excel in various projects, including suspension and adherent cells.  We have completed several projects as a strat...

Abbvie Biologics' Drug Product Development

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  Abbvie Biologics' Drug Product Development Abbvie Biologics' drug development and manufacturing services leverage its proven expertise to provide biologics, biosimilars, and vaccines. Abbvie has extensive experience with drug fill finish process development for all its phases. Our scientists have experience in different sort of formulations and merchandise presentations for your drug product formulation. Whether your molecule needs vials (liquid or lyophilized) or syringes, Abbvie's high-speed filling lines offer the absolute best degree of aseptic processing. They are integrated with secondary packaging to supply your clinical or commercial product to patients reliably. Process Development From cell culture through recovery and purification, our scientists develop processes that ensure consistent CGMP manufacturing performance and a reliable product supply. The use of identical bioreactors helps a smooth transition from non-GMP to GMP manufacturing. Comprehensive, integ...