Sponsored Content

Integrated Solutions for Biologics Formulation and Drug Product Development

This webcast features: Dr. Yunsong (Frank) Li, Director of Process Development, Catalent Biologics There are many challenges to conduct thorough drug product formulation development at early stage drug substance process development. Those challenges include material limitation, suitable analytical method, time and labor cost. Sufficient development of the right formulation and dosage form for biologics products early on helps to avoid formulation redevelopment and change during the later stage of product development, which leads to additional analytical, pharmacokinetics or even clinical…

Enabling Success in Biologic Drug Substance Development and Biomanufacturing by Leveraging Expertise and Collaboration

This webcast features: Steven Perry, PE, Senior Director of Manufacturing Sciences, Catalent Biologics Biologic drug substance development and biomanufacturing is a critical step in the long, complex pathway to approval. There are many considerations to be made around cell line and process development, analytical testing and late stage activities such as process characterization and validation. This presentation discusses: Critical drug substance resource needs of sponsor companies How expertise and collaboration amongst the key stakeholders enables successful development and scale up…

Don’t Just Pass the Baton: Comprehensive Capabilities and Parallel Processes Accelerate Biologic Development Timelines

Biologic drug development from DNA to commercialization involves many moving parts, which can be difficult for companies to coordinate. For example, there are often new expert stakeholders introduced during each stage of development, leading to inefficiencies and confusion. However, with deep expertise and effective communication between teams, companies can reduce risk and shorten time to clinic and, subsequently, to market. In this webinar series, three biologics subject matter experts will discuss critical considerations in their respective areas of expertise: drug…

Speeding Characterization of Biologics: Replace Traditional Assay Technologies with Label-Free Quantification and Kinetics

FortéBio’s Octet instruments are an ideal replacement for ELISA, HPLC, and SPR techniques in quantification of antibodies and recombinant proteins and in testing product potency for lot release. Bio-Layer Interferometry (BLI) technology monitors biomolecular interactions in real time to determine affinity, kinetics, and concentration. The plate-based, microfluidics-free format offers users several distinct advantages over other technologies. BLI-based systems can achieve higher throughput, with the flexibility to measure two to 96 samples simultaneously. Lower maintenance requirements and increased ease-of-use further shorten…

Ask the Expert November: Expediting Characterization and Maximizing Reliability of Process Validation

On 24 October 2018, BPI presented a free “Ask the Expert” webinar with Abel Hastings, director of process sciences at Fujifilm Diosynth Biotechologies. He discussed the use of systematic tools to expedite process characterization and maximize reliability of process validation campaigns. Hastings’s Presentation As a project moves from clinical manufacturing toward process validation — and ultimately toward preapproval inspections — project timelines can become hypervisible at all levels of an organization. Missteps can be costly. The commercial viability of a…

Ask the Expert November: Improving CHO-Cell Biomanufacturing with a Whole-Genome CRISPR Screening

On 18 October 2018, BPI presented a free “Ask the Expert” webinar with Jamie Freeman, a bioproduction product manager at Horizon Discovery. His company is developing a whole-genome screen using clustered regularly interspaced short palindromic repeats (CRISPR) for improving the capacity of Chinese hamster ovary (CHO) cells in biomanufacturing. Freeman’s Presentation Freeman described the screening approach that Horizon developed to improve its own CHO cells. It also may be used to improve other such cell lines for biomanufacturing. Founded 11…

Ask the Expert November: New High-Performance AEX Resin for Purification of Large Biomolecules

On 20 September 2018, Jiali Liao (principal scientist in process chromatography R&D at Bio-Rad Laboratories) led a BPI “Ask the Expert” webinar introducing the high-performance, high-capacity Nuvia HP-Q Anion Exchange Resin, which can be used for purifying large biomolecules. Liao’s Presentation Purifying large biomolecules — e.g., plasma proteins, immunoglobulins, viruses, virus-like particles (VLPs), and PEGylated proteins — can be difficult. Their size makes for slow diffusion through the pores of traditional chromatography resins and poor mass-transfer kinetics, which decreases binding…

Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment

This webcast features: Dr. Anshuman Shukla is Intertek’s Biophysical Characterisation expert at the Center of Excellence for Biopharmaceuticals in Manchester, UK. Structural integrity of protein based therapeutics is one of the major challenges in the biopharmaceutical industry where multiple factors such as the stability, efficacy and shelf life could be affected following minor changes in manufacturing process. This becomes critical particularly with development of more and more biosimilars where comparability to a reference product is required to ensure that the…

Introducing Chromassette: Modular Chromatography Platform with a Lattice Supported Bed

This webcast features: Jason Chiu, Product Marketing Scientist, Bioprocess Group, JSR Life Sciences. Chromassette®, a lattice-supporting modular chromatography device, eliminates the constraints of modern column chromatography. The Chromassette technology offers the separation capabilities of conventional chromatography plus the convenience, scalability and other benefits of a pre-packed cassette through its unique, internal scaffold structure that provides consistent “wall support” to all resin beads. In this webinar we will discuss how Chromassette enables high flow-rates for any type of resin regardless of…

The Complete e-Book of Biosafety Testing

Expect the expected. But plan for the unexpected. If your Biosafety Development takes a nose dive, Eurofins Lancaster Laboratories’ team of regulatory experts and experienced scientists will help you land safely on two feet. Download The Complete e-Book of Biosafety Testing to learn more about our expertise in biologics raw materials, cell bank preparation, adventitious virus testing, viral clearance studies, next-generation sequencing, genetic stability testing, and more. This e-Book contains the following chapters: Mitigating Risk and Reducing Regulatory Scrutiny of…