Risk-based approach to selecting environmental monitoring locations SmartNotes
August 8th 2024Dr. Tim Sandle's SmartNote series discusses how a risk-based approach to environmental monitoring helps facilities maintain control over their environment and supports quality assurance efforts. Plus, they highlight the importance of selecting appropriate monitoring locations and taking proactive measures based on monitoring results to ensure consistent environmental quality and mitigate potential risks to product safety and integrity.
Media and feed development: A step-by-step guide to workflow optimization
September 18th 2023Cell culture media is a foundational component of any biotherapeutic manufacturing workflow, crucial for maintaining cellular health and viability, maximizing titers, and supporting high product quality. As such, building a biotherapeutic manufacturing process with an optimized basal medium and feed system is vital to achieving optimal results and accelerating the speed-to-market of your product. However, the process of finding the most suitable basal medium and supplementation strategy can be challenging, as it requires balancing many key cell culture process variables to achieve specific technical goals within budget and time constraints. This guide will provide an insight into each development stage and offer best practices to help you achieve your project goals on time and within budget.
Readying Biologics for Commercialization
December 14th 2022Given the risks and opportunities inherent in drug development, choosing the right late-phase strategy to optimize timelines and capacity, while remaining flexible enough for changing market conditions, presents a significant challenge to companies developing and commercializing biopharmaceutical products. This piece highlights new technologies and strategies to reduce risk and execute consistently.
New Developments in Mass Spectrometry-Based Single-Cell Proteomics
October 21st 2022Fri, Oct 21, 2022 11:00 AM EDT Learn how Karl Mechtler has developed an end-to-end workflow to efficiently prepare and analyze samples for single-cell proteomics by mass spectrometry. This workflow enables direct injection of single cells to identify approximately 1,500 protein groups per analytical run and uncover the surprising heterogeneity of cell populations.
Characterization of Biotherapeutic Beasts by Mass Spectrometry
September 29th 2022Thursday, September 29, 2022 at 7am PT | 10am ET | 4pm CET Novel methods have been developed and applied on Biotherapeutics Beasts in the half Megadalton to 3-4 MDa range to measure AAV Full:Empty genome ratio using charge detection mass spectrometry on the Q Exactive UHMR mass spectrometer with Direct Mass Technology mode.
Preparing biologics for commercialization: strategies to reduce risk and optimize outcomes
September 28th 2022Wednesday, September 28, 2022 at 10 AM EST | 4 PM CET Optimize your late-phase strategy to prepare your biologic for commercialization. CDMO experts share their time-tested best practices on how to adapt for uncertain market demand to get your drug to market on time.
Building Biotech Series with Brent Cezairliyan
September 6th 2022When it comes to biotech, both the academic and industry settings are crucial in developing novel medicines. Dr Brent Cezairliyan has experienced both sides of biotech, first through an academic career exploring bacterial pathogenesis, and now in his administrative role at Octagon Therapeutics. The company, headquartered in Cambridge, Massachusetts, focuses on autoimmune disease treatments. By developing targeted approaches to the inflammatory nature of the immune system, they hope their advances in biotech help future scientists navigate the field for years to come.
Developing GMP-Manufactured Cas9 Proteins for Therapeutic Applications
June 30th 2022Thursday, June 30, 2022 at 11am PST | 1pm CST | 2pm EST As CRISPR based gene editing progresses from research to therapeutic applications, there is a growing need for high quality GMP grade materials, including the Cas9 protein and supporting instruments, and to minimize off target events. This webinar will discuss the development process of a GMP-manufactured Cas9 protein along with causes of off target events and how to minimize risk with high fidelity Cas9 protein.
A complete “how-to” guide for saliva collection and testing
June 24th 2022To gain a better appreciation for saliva and its growing use within the diagnostics research market, we’ll take a closer look at some foundational questions about saliva’s composition, physiological function, and its underappreciated history in the medical field.
Building Biotech Series with Joshua Schiffman
June 10th 2022After being diagnosed with Hodgkins lymphoma at age 15, Dr Joshua Schiffman was driven to pursue a career in medicine, starting as a pediatric oncologist, and was later drawn to the biotech side of the industry. Dr Schiffman was fascinated with a tidbit of knowledge: elephants almost never get cancer. He met Dr Avi Schroeder at a conference in Israel, and the two wondered how they could take this research about elephants’ cancer-fighting genes and apply it to humans. Together, they co-founded PEEL Therapeutics, the organization’s name meaning elephant in Hebrew, and currently work to bring together nature, medicine, and technology for the betterment of humankind. In this episode, Dr Schiffman provides a hopeful outlook on how nature and biotech can lead scientists to harness the power of evolution and create a bright future for medicine.
Building Biotech Series with Samir Ounzain
April 25th 2022While still considering himself a fundamental basic scientist, Samir Ounzain is embracing the biotech industry trend of merging academic research and biotechnological drug development. In this episode, Ounzain talks about his path from a dark theater as a kid watching Jurassic Park to the lab studying the dark matter of the human genome – and eventually to the founding of Haya Therapeutics, a biotech startup aiming to discover and develop safe and effective, tissue- and cell-selective, genome-based therapies for fibrotic diseases.