CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Aramus Single-Use Bag Assemblies For Cryogenic Temperature Compatibility

  This application note explores the cryogenic temperature compatibility of the Aramus™ bag assembly material through freezing and drop testing after 24-hour minimum immersion in the liquid nitrogen (LN2) vapor phase.

• Beyond The Process: Important Factors For Long-Term Biomanufacturing Success

  For long-term manufacturing success, you need to look beyond the process and account for an amalgamation of many important factors. Your process will go through many different phases, and it needs to be scalable throughout, or you will incur additional challenges and costs.

• Implementing GMP For Early-Phase Development With Cartesian Therapeutics Co-Founder And CEO, Dr. Murat Kalayoglu

  For nascent cell and gene therapies, navigating the earliest phases of clinical development can prove particularly challenging, as even small issues in manufacturing can spell big problems. In this episode of The Business of Biotech, Dr. Murat Kalayoglu, Co-Founder and CEO of Cartesian Therapeutics, talks about the importance of focusing on GMP manufacturing during Phase I clinical trials to maximize a therapy's potential for success.

• Clinical Trial Start To Finish …. That Was Easy

  A sponsor needed to test a new nonsteroidal anti-inflammatory drug (NSAID). Working with an experienced CRO allowed them to line up the 40 best sites in the country for this type of analgesia study and have the best training and tools at each site.

• 21 CFR Part 11 — Are You Ready For An FDA Inspection?

  Part 11 has been scrutinized and criticized over the years, but it remains in effect today. Given the pervasive automation of processes and digitization of data today, the regulation is more relevant than ever. In this paper we break down what Part 11 means and how to get inspection ready.

• Conclusive & Positive Results Delivered Ahead Of Time – By Eight Months

  Most patients with Binge Eating Disorder (BED) seek help from psychiatrists, nutritionists, or obesity specialists, but there was no approved, effective pharmacologic treatment. With unanticipated interest in pivotal Phase 3 studies, we needed to line up and train the right resources while collaborating effectively with the central laboratory, data manager, and other participants.

• Efficient Expansion Of Suspension CHO Cells In Corning® PETG Erlenmeyer Flasks

  The adoption of single-use technologies for biopharmaceutical manufacturing is a rapidly growing trend due to a number of advantages including the reduced risk of contamination, reduced capital costs, and faster time to market. In this study, we assessed the growth of CHO-S cells in Corning 2L, 3L, and 5L PETG flasks with different fill volumes using a typical batch culture protocol. Our results demonstrate efficient expansion and high viability of CHO-S cells in all three flask sizes during 6 days in culture.

• Liposome Testing

  Liposomes are spherical engineered particles made of phospholipids used in the pharmaceutical and cosmetic industries. The size and surface charge of liposomes are important characteristics which require measurement and monitoring. Dynamic light scattering (DLS) is the most common analytical technique used for measuring the size of submicron liposomes. Single particle optical sizing (SPOS) is used to measure the size of liposomes greater than one micron. The Entegris Nicomp® DLS system and AccuSizer® SPOS system are used in laboratories around the world for the accurate measurement of the size and charge (zeta potential) of liposomes.

• Streamlining And Standardizing Cell And Gene Therapies From Process To Product

  Cell and gene therapies are transforming the lives of patients with various rare genetic diseases and more common conditions such as cancer. However, the rapid pace of scientific progress has overwhelmed supply infrastructure, creating pressures to scale manufacturing, increase capacity and meet a wide range of deliverable requirements.

• Evolution Of Treatment Of Atopic Dermatitis

  The Atopic dermatitis (AD) treatment paradigm has significantly evolved in the last five years. Currently, AD is an area of intense focus for clinical developers. Globally, more than 100 pharmaceutical and biotechnology companies are investigating new therapeutic solutions for AD. This white paper will explore the pathophysiology of atopic dermatitis, as well as the rationale and mechanisms of action of existing and emerging therapies for AD.