Upstream Processing

Quality by Design (QbD): Defining Hydrolysates & Designing Quality

Complex. Undefined. Variability. These are all typical attributes that are used to describe protein hydrolysates because they are exactly that — complex, undefined and their performance may vary on a lot-to-lot basis. But despite all of the uncertainties, using hydrolysates as media supplements can stimulate cell growth and improve protein production — and ultimately lower the cost of goods tremendously. That is why the scientists at FrieslandCampina Domo have started the project “Defining Hydrolysates and Designing Quality.”

In this educational webcast, Dr. Jan Boots of FrieslandCampina Domo answers the questions — Can hydrolysates be defined? And can consistent quality be designed into them? Join Dr. Boots as he explores the complexity of hydrolysates and how Domo is working to define them.

Putting It All into Perspective

    As part of The Automation Partnership’s “20 Years of Automated Cell Culture” series, science writer Sue Pearson interviewed Dr. John Birch, the chief scientific officer of biopharmaceuticals for Lonza Custom Manufacturing APIS based in Slough, UK. Birch has been with that company since 1996, Before that, he held senior technical positions at Tate and Lyle, GD Searle, and Celltech. Birch has a PhD in microbiology from London University, where he also spent a period lecturing before moving into…

Minimizing the Environmental Footprint of Bioprocesses

    Biomanufacturers must take active measures to minimize their environmental footprints and promote environmental sustainability. The collateral benefit of reducing environmental footprint often is viewed as only a secondary consideration after cost of goods and product quality. Biopharmaceutical processes are 80% defined by the time of proof-of-concept studies (clinical trial stage 2b). This milestone is before the official technical transfer to commercialization or manufacturing organizations and almost always before the environmental evaluation of a production process. This step is…

Demonstrated Performance of a Disposable Bioreactor with an Anchorage-Dependent Cell Line

    Increased adoption of disposable storage vessels and mixing systems for biopharmaceutical manufacturing operations has provided economic and efficiency benefits to a number of life-science companies. Single-use technologies have reduced validation requirements, shortened turnaround times, eliminated cleaning regimes, increased the speed of set-up procedures, and facilitated the development of flexible manufacturing platforms. Many biomanufacturers have sought to extend those benefits into the field of cell culture by using disposable bioreactors. Here we describe work undertaken to develop and demonstrate…

Measuring Manufacturing Cost and Its Impact on Organizations

    The first article in this periodic series reviewed the impact of cost pressures on the biopharmaceutical industry, in particular the challenges the industry faces in relation to high capital costs, complex processes, and long product development cycles (1). Here we examine what companies are doing to assess costs in decisions about process and technology choices relating to manufacturing of biologic drug substances. We will look into what companies are currently doing and what they need to be doing…

Single-Use Technology

Single-use technology began on the downstream side of bioprocessing, primarily in presterilized filter capsules and plastic biocontainers for buffers and media. Since then, it has expanded to upstream operations, including disposable bioreactors and mixers. The newest trend is to move further downstream into sterile formulation and filling. With the increasing popularity of disposable systems, some users are wondering what is being done to standardize the various components from different manufacturers and what BPSA (the Bio-Process Systems Alliance) is doing to…

Are Generic HCP Assays Outdated?

    Biomanufacturers face a conflict between low-cost generic host cell protein (HCP) assays and highly sensitive but more costly process-specific HCP assays that are usually not initiated until the proof-of-concept stage. But drug developers cannot expect sufficient sensitivity from most commercially available generic assays. For some companies, multiproduct HCP assays could offer a solution to the dilemma. Biopharmaceutical manufacture using genetically modified microorganisms and cell lines is typically associated with contamination by process-related impurities. One of the most important…

Potelligent® CHOK1SV: The Evolution of the GS Gene Expression System™

Lonza and BioWa have combined their technologies to produce a new host cell line, Potelligent® CHOK1SV. This new cell line merges the benefits of Lonza’s GS Gene Expression SystemTM with those of BioWa’s POTELLIGENT® technology. Recombinant cell lines created using this new and improved host cell line have shown:

• Enhanced ADCC
• Growth suitable for a production process
• High product concentration levels in a platform process
• Ability to work seamlessly with current manufacturing processes

Join Allison Porter of Lonza Biologics as she provides a detailed look at the two technologies separately and the performance of the new Potelligent® GS-CHO technology.

Anatomy of a Single-Use Bioreactor Deployment

Rapid commissioning and start-up enabled by system design and process support

Deploying a new GMP single-use bioreactor requires the careful coordination of hardware, software, disposable components, process engineering, tech-transfer and other disciplines. When time pressure is involved as it often is in the current business environment, the task of mastering an unfamiliar piece of process equipment can provide a challenge to biopharm organizations. Recognizing this, Xcellerex has designed the XDR single-use bioreactor as a fully-integrated system that is engineered for rapid delivery and start-up, capable of going from order to delivery to working process in just 12-16 weeks. Further, the Xcellerex team uses XDR reactors every day in our own GMP operations, allowing our technical team to provide fully informed support to customers. This webinar provides an overview of XDR deployment capabilities, and shares a recent customer case history of a successful rapid XDR deployment.

Using Disposables in Cell-Culture–Based Vaccine Production

    A recent private grant of US$10 billion for human vaccine applications illustrates the revival of interest in vaccine science (1). The 2009 response by vaccine manufacturers to the H1N1 pandemic revealed the convergence of three technological developments. First is a revolution in technology: Vaccines are being developed for diverse and unprecedented applications through a number of entirely new approaches. Second is the recent adoption of cultured cell-based production for a growing number of vaccines, such as influenza. And…