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eBook: Biologics Stability — Lifecycle Management of Drug Products

The biomanufacturing industry’s increasing attention to risk mitigation through quality by design (QbD) and the emergence of complex therapeutic modalities have driven the need for a lifetime-management approach to assuring drug product stability. To that end, industry guidelines have been (or are being) developed to guide the industry toward a “holistic approach” to conducting stability assessments. However, not all methods are stability indicating, and many more industry concerns need to be addressed. This BPI eBook offers perspectives on ICH Q12…

Critical Considerations for Fill–Finish Manufacturing: Demand to Increase Speed and Flexibility While Maintaining Sterility Spurs Adoption of Novel Technologies

by BJ Hull

The global market for biopharmaceuticals continues to grow at a rapid pace, with a 9.5% compound annual growth rate (CAGR) predicted over the next eight years. That translates into more than $500 billion in projected growth. So it is no surprise that biopharmaceutical manufacturers are investing heavily in new facilities, technologies, and pipelines for manufacturing drug products. Even so, the need to prevent contamination places stringent handling and packaging requirements on biomanufacturers. Sterilizing equipment often requires steam autoclaves and dry…

Dye Ingress Methods for Container–Closure Integrity Testing: An Industry Position Paper

by Scott Ewan, Stefanie Adler, Nicolas Coopmans, Marta Corcoran, Sean Fadden, Chris Feeney, Jason Fernandez, Henri Hebting, Olivia Henderson, Steve Klohr, Michael Koby, Josh Lance, Brian Lee, Lei Li, Doug McNeill, Roman Mathaes, Dale Moore, Jeff One, Kashyap Panya, Suzanne Pellinen, Amanda Scruggs, Kamran Simani, Mauro di Stefano, Jared Trefethan, Harold van Deinse, Brian Vanness, Amy Wang and Klaus Wuchner

The primary goal of container–closure integrity (CCI) is to maintain the sterility and product quality of parenteral biopharmaceuticals throughout their shelf life and use. Guidelines detailing the initial CCI qualification and validation requirements have been defined and can be found in the US Pharmacopeia chapter 1207 (USP<1207>) (1). The guidelines described in USP<1207> can be applied to any common CCI testing (CCIT) method to achieve a method suited for its intended use within a drug product lifecycle. CCI is not…

A Product–Packaging Interaction Study to Support Drug Product Development

by Mike Ludlow

Drug packaging is subject to a number of regulatory requirements, including those for product containers and packaging. For example, according to the federal Food, Drug, and Cosmetic Act (FD&C) section 501(a)(3), a drug is considered adulterated “if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.” And 21 CFR states that drug packaging “shall not be reactive, additive, or absorptive so as to alter the safety,…

Large-Volume Wearable Injectors: A New Delivery Approach Could Change the Game

by Michael D. Hoover

Biologic drugs are a driving force in the pharmaceutical industry. More than 2,700 were in pharmaceutical pipelines as of June 2017 to treat cancers (836), rare diseases (566), neurologic conditions (420), autoimmune disorders (311), and other ailments (567) — triple the number in 2013 overall (1). Biopharmaceuticals make up more than half of all drugs in development and are nudging out traditional small-molecule drugs rapidly while already bringing in billions of dollars in sales. The success of such drugs is…

Conference Report: The Drug Product Track at 2017’s BioProcess International Conference and Exhibition in Boston, MA

by Cheryl Scott

At the Hynes Convention Center in Boston, MA, during Knect365’s “Biotech Week Boston” in late September of 2017, one track of the BioProcess International Conference focused on drug products, fill–finish, and formulations. Presenters represented a number of major biopharmaceutical companies — AbbVie, Amgen, Biogen, Eli Lilly, Genentech (Roche), GlaxoSmithKline, Johnson & Johnson, Lonza, Pfizer, and Sanofi — as well as suppliers Bosch, Merck (MilliporeSigma), ReForm, and Single-Use Support. They focused on predictive modeling, quality by design (QbD) and process analytics,…

A Vaccine Case Study: Qualifying Redundant Disconnection Technologies As Container-Closure Systems for Long-Term Storage and Shipping

by Christine Megarity and Bobbi Allen

The expanding complexity of biopharmaceutical manufacturing puts increasing pressure on single-use systems to meet the demands of the modern industry’s global footprint. Individual sites within a given organization often are specialized to a fixed number of “modular” process steps (1). Such product segregation increases plant efficiency and output while making the best of staff competencies. But it also can create an additional need for transportation of intermediate or bulk drug substance (BDS) over long distances. Freezing generally is used to…

Beyond Compliance: Serialization Has More to Offer

by Steve Wood

As the global pharmaceutical industry implements serialization (track and trace from manufacturing to dispensing) to meet governmental regulatory requirements, other opportunities arise for drug companies. The main driver here is to improve the integrity of the overall drug supply chain, but other meaningful business benefits can come from serialization. Generally accomplished through automated, electronic means, it involves such practices as recording, authenticating, maintaining, and sharing accurate records of products. Outside-the-Box Benefits In addition to tightening up the supply chain and…

Serialization: Background, Justification, Requirements, Timelines, and Readiness Across the Supply Chain

by Dan Walles

Drug manufacturers are facing unprecedented serialization challenges. Serialization requires weighty consideration and focused strategy for successful commercialization, even for those companies that have yet to bring a product to market. The World Health Organization estimates that 10% of medicines worldwide and up to 50% of drugs consumed in developing nations are counterfeit. In response to increasing drug integrity concerns, more than 40 countries have introduced laws mandating serialization and tracing of pharmaceutical products as they pass through the supply chain.…

CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations

by Siddharth J. Advant, Jee Chung, Gary Hartman, Mark H. Lee, Lana Shiu, John Towns, Sarah Kennett and Andrew Weiskopf

On 26 January 2015, CASSS hosted a program in its ongoing series of semiannual Chemistry, Manufacturing, and Controls (CMC) Strategy Forums at the Mayflower Hotel in Washington, DC. Since this series’s inception in 2002, each installment has focused on one of a wide array of topics spanning the fields of biopharmaceutical product development, manufacturing, analysis, quality, and regulation. For this forum, the program committee chose to devote a full program to a topic that was previously the focus of an…