Special Reports

Optimizing Process Economics Across Modalities

Today’s drug manufacturers are faced with the need to find efficiencies across a wider range of modalities than ever before, even as gaps in technology still exist. The economics of the process includes cost and time and must also consider quality and reproducibility. Working with suppliers that understand the full scope of drug development and commercialization challenges, and provide reliable, scalable solutions tailored to each unique process is critical to success. In this e-book, the team from Polyplus reintroduces the…

DNA to IND in 13 Months: A CMC Strategy for Bispecifics

Multichain protein biotherapeutics such as bispecific molecules have been developed to treat cancer, neurological and ophthalmic disorders, and autoimmune and inflammatory diseases. Early successes now are driving greater numbers of such molecules toward clinical evaluation and commercial approval. However, the complexity of bispecific development and manufacture calls for innovative tools and technologies to facilitate the clinical journeys of such products and prevent costly setbacks for their sponsors. In its commitment to fostering novel biomolecular formats, Lonza has designed a chemistry,…

High-Selectivity HPLC mRNA Analytics: Quantification and Characterization

Robust and precise chromatographic analytical methods are key for the efficient development of the mRNA production process. Three different analytical methods, which utilize three different column chemistries, are embedded in a ready-to-use PATfix™ HPLC analytical platform to support mRNA process development and product quantification and characterization. Fill out the form below to download the full report from BIA Separations, now a Sartorius Company.  

Host Cell Protein Analysis: Immunoassays and Orthogonal Characterization By Antibody Affinity Extraction and Mass Spectrometry Methods

Reduction of Host Cell Proteins (HCPs) to the lowest levels practical requires sensitive and robust analytical methods. In this Special Report, Cygnus Technologies discusses industry best practices for HCP analysis and integration of orthogonal methods for in-depth HCP characterization using Antibody Affinity Extraction (AAE) and Mass Spectrometry (MS). Download the report to learn about: Antibody Affinity Extraction for HCP antibody coverage analysis to ensure HCP ELISA is broadly reactive and fit for purpose of process monitoring and product lot release…

Optimizing Bulk Drug Substance Storage and Shipment: Key Considerations for Rigid Container Design

When choosing a container for critical drug substances, the material of construction should be your first consideration. It is arguably the most important indicator of container success. Fluoropolymer containers such as Purillex bottles are an excellent choice for BDS storage, freezing, and shipment because of their proven physical and performance advantages. This special report outlines robustness testing of fluoropolymer BDS containers focusing on extractables and leachables, container–closure integrity, durability, gas permeability, and performance during freezing and thawing. Fill out the…

Concentration and Purification of Infectious Viruses

Throughout evolution, viruses have developed mechanisms to interact with and manipulate the genetic material of their target cells. As a result, modern virology uses a growing number of applications to understand these agents of disease. Such applications range from transfection of cells for genetic manipulation to medical studies with a strategic focus on developing novel vaccines, treatments, and gene therapies. Assessment of virus type and content is also important for ensuring food and drinking water safety as well as for…

Small Samples, Big Discoveries: Characterizing AAV Aggregates at Low Volumes and Identifying Their Root Causes

Gene therapies that use AAVs have shown great promise, but can be unstable due to their fragile composite DNA/protein nature, which presents an analytical challenge when determining root cause of subvisible particle (SVP) formation and product instability. Understanding how these proteins interact with leaked payloads will allow better insight into avoiding aggregate buildup. Yet, this has been difficult, hampered by legacy systems that cannot conduct low volume SVP analysis or interrogate for DNA content. That’s about to change. In one…

Delivering on the Promise of Bispecifics: State-of-the-Art Bispecific Antibody Development

Bispecific antibodies (bsAbs) have transformed the field of immunotherapy. However, moving these life-changing therapeutics from the bench to the clinic can be time-consuming and costly. Further, challenges such as aggregation, degradation, fragmentation, and denaturation may ultimately hinder a program from advancing to the clinic. Partnering with a CDMO with relevant experience and technologies can be critical for safely and cost-effectively manufacturing bispecific antibodies. With Selexis’s cell line technology and KBI Biopharma’s manufacturing and analytics, we lead the industry in technologies…

Increasing Dynamic Binding Capacity of Oligo(dT) for mRNA Purification: Experimental Results Using CIM 96-Well Plates

Messenger RNA (mRNA) emerged as a powerful therapeutic tool for treatments in gene therapy, oncology, and infectious diseases, as recently demonstrated by vaccines against Covid-19. mRNA is produced by an enzymatic reaction that can be rapidly designed and scaled-up, and the platform is highly adaptable to different targets. One of the greatest challenges in mRNA production is the removal of process-related impurities stemming from in vitro transcription (IVT) reaction, such as residual nucleotide triphosphates, DNA template, enzymes, abortive transcripts. Affinity-based…

Sustaining Project Management Business Continuity and Partnerships Throughout COVID-19

The Avid project management office employed unique technology and communication techniques to maintain business continuity and material supply to our partners and the patients they serve throughout each COVID surges. The presentation will take a deep dive into the challenges and solutions encountered for each functional area in the biologics development and production process during the early COVID pandemic and later surges. Ultimately, discussing the lessons learned to maintain both internal and partner engagement during challenging times. Fill out the…