Manufacturing

Advanced Materials for Single-Use Biomanufacturing Systems

This webcast features: Michael W. Johnson, Business Development Engineering Manager, Life Sciences, Entegris Utilizing advanced fluoropolymer materials in single-use systems has distinct advantages in regards to extractables, chemical compatibility and cold temperature performance. This webcast examines data obtained from pilot scale testing of a new fluoropolymer single-use bag system for the freezing, storage and shipping of formulated bulk biopharmaceutical product.  You will learn: What material has the widest temperature profile from +200 to -200°C Which film material (LDPE, Polyolefin, EVAM,…

Improving Protein Folding Control and Scalability Using imPULSE Mixing Technology

This webcast features: Anthony Hawrylechko, Director of Microbial Bioprocess, Cytovance Protein folding by dilution is a common approach used in the manufacturing of biologics derived from microbial expression systems. This typically involves the solubilization of a washed inclusion body preparation containing the concentrated product polypeptide with a strong chaotrope or detergent solution. The denatured, inactive product solution is then diluted into a combination pH and red/ox buffer solution. Within this environment, the molecular diffusion rates of chaotrope, buffer components, and…

The Total Cost of Buffer Preparation and Handling

This webcast features: Eric Langer, Managing Partner, BioPlan Associates, Inc. Most bioprocessing facilities consider in-house preparation of buffers and bulk liquids to be a core bioprocessing task. However, some companies are now outsourcing liquid manufacturing, by purchasing ready-to-use materials from vendors or hiring CMOs to prepare these. Buffers and bioprocessing liquids are one area of upstream production operations that is seeing an increase in outsourced operations. Bulk liquids can be a bottleneck in downstream processing, with buffer volumes often required…

Reveal Information That Gives Insights: New Approaches to Sub-Visible Particle Characterization

This webcast features: Josefina Nilsson, Head of EM Services,  and, Gustaf Kylberg, Product Manager – MiniTEM, Vironova Sub-visible particle characterization is essential when comparing sample quality after different purification steps or for the understanding of product stability. Analysis performed with MiniTEM provides both morphology and accurate quantitative data that can help speed up process and formulation development. In this webinar you will learn: How MiniTEM automatically images, detects and classifies a large number of particles resulting in statistically significant and…

Top 5 Considerations When Looking to Outsource to a Biomanufacturing Partner

This webcast features: Paul Jorjorian, Director, Global Technology Transfer, Patheon Biopharmaceutical companies are facing increasing constraints when developing and manufacturing their large molecule drugs. Development labs and manufacturing suites have limited capacity making it nearly impossible to right size internally for uncertain forecasts. As a result, selection of the right biomanufacturing partner has never been more important – for small and mid-size biopharma companies alike. There are an ever-increasing number of options and many criteria to consider during the vendor…

Practical Aspects of Implementing Continuous Bioprocessing

This webcast features: Dr. Marc Bisschops, Principal Scientist, and Dr. Mark Schofield, Principal Engineer, R&D, Pall Life Sciences The next evolution in the biopharmaceutical industry is the widespread adoption of integrated continuous bioprocessing for biologics manufacturing. The key to its success, however, is the availability of novel upstream and downstream technologies that will not only reduce facility footprint, capital expenses, and product cost of goods, but will also increase process productivity, flexibility, and further facilitate the utilization of single-use and/or…

Acceleration of Bioprocess Development Using DoE and Physiological Control

This webcast features: Professor Christoph Herwig, Department of Biochemical Engineering, Vienna University of Technology Bioprocess Development for biotechnological high value added products is still a time consuming task. The reason for this is the high complexity of interdependence between process variables, product quality attributes and process parameters. The demonstration of understanding these interdependencies is however key to achieve regulatory acceptance according to Quality by Design (QbD) principles. Hence, it is important to set up senseful experiments and to gather as…

Eliminating the Ups and Downs of Staffing Challenges

This webcast features: Beth DiPaolo, M.A., SPHR, President, Eurofins Lancaster Laboratories Professional Scientific ServicesSM Many pharmaceutical and biopharmaceutical companies are currently experiencing strong development pipelines, but they face challenges associated with balancing the expanded workloads with restrictions on employee headcounts. To combat this, companies often turn to temporary staffing; however, due to the challenges in finding, training, and retaining motivated talent, the temporary staffing model does not meet current demands in these areas. As an expert with 14 years of…

Single-Use Biopharma Product Recycling: An Alternative Process to Unlock the Challenges

This webcast features: Jacqueline Hollands Ignacio, Corporate Responsibility Programs Manager – Customer Initiatives, MilliporeSigma, and Michael Farrell is Corporate Disposal Coordinator, Triumvirate Environmental. As the biopharmaceutical industry increases the adoption of single-use manufacturing products, the issue of recycling becomes a challenge. Disposal and recycling the plastics from these products is a challenging task due to many factors such as limitations within the recycling infrastructure, products containing a mix of materials and plastics, and biopharmaceutical products can contain biologically hazardous materials…

An Extractable and Leachable Program for Assessing Single-Use Components and Systems

This webcast features: Chris Shields, Director of Global Product Validation Services at Saint-Gobain Life Sciences. Extractable testing is traditionally performed by single-use suppliers, and while not required by industry regulations, it is the drug manufacturer’s expectation that this information form part of a product’s data package. Extractable and leachable testing is designed to determine the chemical compounds that may migrate into the customer’s fluid from the single-use product’s fluid contact layer. Extractable testing utilizes aggressive but relevant test conditions, while…