BPI White Papers

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.

Preclinical Immunogenicity Assessment

Protein therapeutics can potentially elicit immune responses when administered in humans. These antidrug antibodies could result in partial or complete loss of drug efficacy and other complications that have the potential to cause severe adverse effects in the patient. In this webcast, Philippe Stas, Head of Applied Protein Services at Lonza, discusses the benefits of preclinical immunogenicity assessment, including:

• Early-stage Risk Assessment
• Improved Quality and Safety of Drugs
• Reduced Attrition Rate in Drug Development Programs

View this webcast to learn more about managing drug-induced immune responses at the earliest possible stage to produce safer and more cost-effective protein therapeutics.

Quality, Speed and Flexibility by Design

Accelerating the path to new biomanufacturing capacity typically corresponds with increased costs and the risk of lower quality. Overcoming these compromises requires a holistic QbD-based rethinking of how biomanufacturing is approached. By rethinking biomanufacturing equipment, facility design and services, Xcellerex has achieved dramatic improvements in deployment time, while also reducing capital investment, operating costs, and improving overall quality and compliance. This webcast discusses the advantages of the FlexFactory® Biomanufacturing Platform, such as:

• Multi-product, simultaneous manufacturing
• Open platform for any bioprocessing technology/process control
• 70% reduction on time to build/validate to GMP ready (9mo.)
• And more.

Join Parrish Galliher, Founder and Chief Technology Officer at Xcellerex, as he provides an in-depth look at the technology behind Xcellerex’s FlexFactory Biomanufacturing Platform.

Industrial Purification with Convective Interaction Media™ Monoliths

Monoliths offer a unique set of characteristics that, when properly applied, can significantly improve the overall productivity of the manufacturing processes. In this educational webcast, Tony Brazzale of BIA Separations explores the technology behind the CIM™ Monolithic Columns and its many benefits, including:

• Increased facility capacity
• Accelerated ROI
• Improved productivity
• Reduced cost of labor and overall COGS

View this educational webcast to learn more about how CIM Monolithic Columns can improve your manufacturing process.

A Novel Filtration System Used to Intensify Upstream and Downstream Operations

Want to improve your bioprocess? The ATF™ System from Refine Technology was designed to do just that. Used in various bioprocessing applications, this system provides a more reliable and efficient process of cell separation with the inherent ability to support cell growth to extreme concentrations. This educational webcast discusses the Alternating Tangential Flow technology of the ATF System and its many benefits, including:

• Near-linear scale-up
• A filtered product stream ready for purification
• Faster, simpler virus production with a reduced cost of goods
• And more

Join John Bonham-Carter, VP of Sales and Business Development at Refine Technology, as he provides a detailed look at the ATF System, its applications and its benefits.

pDNA Production and Purification

In recent years, there has been a growing demand for DNA-based therapeutics, commonly known as gene therapy, to combat genetically-based pathologies. Because plasmid DNA have significantly different biophysical characteristics than proteins, their production can have a drastic impact on downstream purification unit operations. Join Dr. Stephen Palmieri and Dr. Jesse McCool of Lonza Biologics and Dr. Fred Blattner of Scarab Genomics as they take a detailed look at the challenges faced by pDNA manufacturers and how Lonza’s pDNA Production Platform addresses those challenges.

Technology Transfer of CMC Activities for MAb Manufacturing

As monoclonal antibody products succeed and advance through development, their manufacturing requirements change. The probability of a smooth and successful technology transfer process depends on several factors. Sending and receiving parties must be well aligned in expectations, which can be facilitated by early and detailed planning and communications.

To help companies developing MAb products, BioProcess Technology Consultants recently published a comprehensive report outlining the complex technical, regulatory and strategic chemistry, manufacturing and control (CMC) activities necessary to successfully advance new MAbs from discovery to first-in-human clinical trials and the market as quickly and economically as possible. Read this informative white paper to learn more.

Improving IEX Throughput and Performance with Differentiated Chromatography Sorbents

As upstream processing becomes more optimized, it increases the amount of impurity and contaminants to be removed from large volumes of feedstock. With this added pressure on downstream processing, there is a pressing need for more efficient chromatography operations.

In this paper, the authors describe how they characterized differentiated selectivity of Q and S HyperCel ion-exchange sorbents. They evaluated the dynamic binding capacity in various pH, conductivity, and residence time conditions; carried out a separation of a model mixture to further characterize the sorbents’ specific selectivity; and report on a real case application in which one was used in a capture step for purification of a recombinant protein from an E. coli lysate.

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.