Until recently, China had not been considered a global contender for outsourced biopharmaceutical manufacturing. In fact, it’s been less than a decade since pharmaceutical contract manufacturing in China became legal (1). Yet, the industry now ranks China as the most likely biomanufacturing outsourcing location. According to our recently released study, 17% of the industry considers China as the top future offshore production destination (Figure 1). The BioPlan 2011 Eighth Annual Report and Survey of Biomanufacturing Capacity and Production shows China…
2011
Global Marketplace
Syringe Technology Product: Dual-chamber Lyo-Ject syringe and V-LK cartridge Applications: Delivery of lyophilized, liquid-powder, and liquid-liquid mixtures Features: Vetter offers two efficient and user-friendly systems for freeze-dried parenteral drugs: the dual-chamber Vetter Lyo-Ject syringe and dual-chamber V-LK cartridge. Lyophilized drug is contained in one chamber; diluent in the other. Reconstitution occurs immediately before administration in a few simple steps. This technology simplifies administration, increases API yields (by reducing overfill), and improves dosing precision. Syringes come in 1-mL, 2.5-mL, and 5-mL…
Top 10 Changes in FDA’s Process Validation Guidance
Two years after drafting a comprehensive revision of the 1987 process validation guidance, the FDA finalized the document this year. The revision elaborates on modern quality by design (QbD) techniques for developing a process, analyzing risks, and monitoring for control. The initial draft update remains largely intact, with some important adjustments focused on clarifying the FDA’s intent for how the industry is expected to validate its processes. 1 — Minor Changes: The guidance includes more references to the Code of…
From the Editor
Bonjour! I am writing this from Nice, France, on the last day of the eighth annual BPI European Conference and Exhibition organized by our London-based Informa Life Sciences colleagues. Despite the attraction of some exquisite spring weather (a welcome respite for me from the rain-drenched Pacific Northwest), sessions were well attended till the very end, and discussions were lively and productive. This event was organized into five tracks: manufacturing strategies, process optimization, economics and QbD; cell…
Improved Downstream Technologies Are Needed to Boost Single-Use Adoption
Greater adoption of single-use systems in biomanufacturing is going to require downstream device innovation. To get there, over a third of the biopharmaceutical industry is demanding that suppliers innovate and develop new single-use purification devices, according to BioPlan Associates, Inc.’s annual survey of biopharmaceutical manufacturing capacity (1). Such new products would create exceptional opportunities for innovators. However, calls for new, more fully integrated single-use technologies and processes will require more adventurous innovation on the part of biomanufacturers and their suppliers.…
Disposable Downstream Processing for Clinical Manufacturing
Although disposable parts and modules have been used in the biopharmaceutical industry since the 1970s, as detailed in the “History†box, total disposable manufacturing has become a viable option only very recently. Whereas liquid storage became disposable in the 1990s, processing operations such as depth filtration, tangential-flow filtration (TFF), and chromatography have still required skids with reusable flow paths that needed cleaning and sanitization. Important recent milestones in total disposable technology included introduction of stirred bioreactors by HyClone (Thermo Scientific)…
Implementing a Single-Use Solution for Fill–Finish Manufacturing Operations
Fill–finish is the final operation in manufacture of sterile products (except for terminally sterilized products). This process requires sophisticated technology and machinery in a highly controlled, aseptic environment. Fill–finish assemblies must meet stringent requirements to ensure flow-path sterility and integrity, ensure operational safety and efficiency, and provide fill-volume accuracy to exacting requirements. Traditional fill–finish machinery comes as fixed systems comprising complex components that require assembly, cleaning and sterilization, disassembly, and material storage after filling is complete. Those operational…
Quality By Design and the New Process Validation Guidance
Where were you in 1987, and what were you doing? I’m not too embarrassed to say that I was beginning my last year of high school and paying far more attention to guitar lessons and writing my first novel than what I might eventually do for a career. Meanwhile, the US FDA was publishing a guidance document on process validation that the biopharmaceutical industry has relied on ever since. I’m willing to bet that quite a few readers…
A Case Study in Qualification of Single-Use Filling Manifolds for Particles and Endotoxins
Single-use technology is being examined for implementation in an increasing number of steps in the biopharmaceutical manufacturing process. Some examples of currently available disposable components include filter capsules, tubing, connectors, and biocontainers (for storage, mixing, and bioreactors), as well as devices for chromatography and multipass tangential-flow filtration (1,2). This technology was first implemented in upstream and API downstream processes such as media and buffer preparation, followed by upstream bioreactors and mixers (3). The single-use trend has most recently…
The New US Biosimilar Legislation, One Year Later
About a year ago, President Obama signed into law the highly publicized health care reform bill known as the Patient Protection and Affordable Care Act. This legislation included the new Biologics Price Competition and Innovation Act of 2009 (now a “biosimilar statuteâ€). Before enactment of that biosimilar statute on 23 March 2010, no “abbreviated†regulatory approval system existed in the United States for biologics — unlike Europe, which has had a system since 2005, and unlike US generic…