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Multi-Mode Mimetic Ligand™ Library – A Rapid Screening Toolbox for Target Protein Purification

Small synthetic ligands have established themselves as an essential component of modern downstream processes, both as specific ligands for product capture or the targeted removal of impurities and more generally for product polishing applications. Historically, the identification of a specific ligand for a target protein has required the engagement of specialist companies. Whilst this approach can be very successful, such studies often require some time to set-up and perform (i.e. from ligand discovery, to adsorbent/process development and finally manufacture) and…

Targeting Desired N-Linked Glycosylation Profiles Through The Use Of Glycosylation Enhancing Feeds And High Throughput And High Resolution N-Glycan Analysis By Multi Capillary Electrophoresis

Glycosylation is a key product quality attribute for many biotherapeutic proteins expressed in CHO cells. N-linked glycans may display macro- and micro-heterogeneity; the degree of this variation can depend on several factors, including cell line, media/feeds, and process. As a consequence, it has often been challenging to achieve and maintain preferred glycosylation profiles from cell culture development through bioreactor scale-up. In order to address these challenges, we have developed a new feed technology in conjunction with a unique fed-batch process…

High Density Culture Strategies For Improved Scalability With Single-Use Systems

Improvements in single-use systems have allowed implementing high-density cultures in standard work flows. The current study shows integration of the Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.) and the XCell™ ATF6 Single-Use (SU) System to achieve high-density cultures. Current results are compared against similar cultures using a stainless steel ATF6 system. The S.U.B. was able to support high-density cultures (>40E06 cells/mL) without modification to standard single-use components and maintained proper operating parameters. Scale-up criteria for both S.U.B. and ATF are provided…

Rapid and Simple Sample Preparation for High Throughput, High Resolution and Sensitive Glycan Analysis by Capillary Electrophoresis

Here, we report the simple and rapid GlycanAssure™ workflow that combines high throughput and high resolution glycan analysis of 96 samples in 7-9 hours using Applied Biosystems™ 3500xL 24-capillary electrophoresis system. The process eliminates vacuum drying and highly toxic cyanoborohydride in the labeling reaction. Use of Dynabeads™ magnetic beads for glycan purification post deglycosylation and removal of free dyes after labeling streamlines the process for automation. Capillary electrophoresis can detect less than 0.2 fmol/μL of labeled glycans. Two proprietary fluorescent…

Innovative Hydrophobic Interaction Chromatography (HIC) Resins for Next Generation Molecule Challenges

Advances in biotherapeutics are generating a wider range of biomolecules that are presenting unique and often difficult separation and purification challenges. Based on the complex needs of the industry a series of HIC prototypes were developed over a range of hydrophobicity. Utilizing extensive user input, design goals focused on development of resins with market leading resolution and capacity, as well as optimized surface and flow characteristics for increased throughput and high product recovery. All of which are typical pain points…

Ultimate Flexibility from Pre-Packed to Unpacked: OPUS 45R and OPUS 60R Columns

This webcast features: Fletcher Malcom, Director of Product Management, Repligen With an innovative side port that allows for easy resin unpacking, OPUS® 45R and OPUS® 60R Columns provide the ultimate flexibility in pre-packed column technology. Without compromising chromatographic performance or cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in CGMP settings, and allows for re-use of the unpacked resin in other columns. This webinar covers test results on chromatographic performance, bioburden testing, shipping tests and simple…

Medium and Feed Development: Beyond Maximizing Protein Titer to Optimizing Glycan Distribution and Simplifying Process Scale-Up

Serena Fries Smith, associate director of global technical engagements for Thermo Fisher Scientific, covered advantages in feed solutions in the context of current industry trends in an early November webinar. Leveraging feed designs and strategies can optimize glycosylation of complex proteins, simplify scale-up of fed-batch processes, and improve expression titers. Smith’s Presentation In 1994, the average expression titer was 0.5 g/L. Thanks in part to improvements in culture feeding, titers had increased to 1.3 g/L in 2004. By 2014, they…

Enabling Custom Solutions for Downstream Processing of Future Therapies: An Adenoassociated Virus Case Study

Orjana Terova is a purification product manager in the bioproduction division of Thermo Fisher Scientific. In a BPI webinar on 9 December 2016, she discussed the company’s custom resin program for purification of biological products. Thermo Fisher Scientific has dedicated a pilot-plant facility for this program. Terova’s Presentation Speed is the main development driver in downstream processing, but quality and efficiency are always critical. Purification processes need the highest resolution, capacity, salt tolerance, and operation speed possible. Consistency and reproducibility…

Improving Single-Use Bioreactor Design and Process Development: New Research Toward Intensifying Seed-Train and Scale-Up Methods Using 5:1 Turn-Down

In an early October webcast, Surendra Balekai (senior global product manager for bioproduction at Thermo Scientific) discussed improving bioreactor design for a 5:1 turn-down ratio. Balekai has worked for over 17 years with biological manufacturers in designing processing equipment for developing vaccines, blood products, and recombinant proteins. Balekai’s Presentation When bioreactors operate at a 5:1 ratio (20% volume), the primary challenges are carbon dioxide build-up in the headspace and fluid mixing at low volume. The CO2 produced will significantly affect…

Reveal Information That Provides Insights: New Approaches to Subvisible Particle Characterization

In an October webcast, Vironova’s Josefina Nilsson (head of electron microscopy services) and Gustaf Kylberg (MiniTEM product manager) discussed subvisible particle characterization using the MiniTEM system, which provides both morphology and quantitative data. Nilsson and Kylberg’s Presentation Vironova combines expertise in electron microscopy and image analysis with in-house designed software. Electron microscopy is a good technique for getting to know your product in detail (morphology and other characteristics). After discussions with partners and clients, Vironova worked with Delong Instruments to…