Articles in this Issue

• 

  Computer Vision is Providing a New Lens Into Biopharma Innovation

  Computer vision (CV), a form of AI that uses an algorithm to identify, process and analyze vast amounts of text, images and videos that would be impossible to address with the human eye, has been ... read more
• 

  Improving Preclinical Drug Safety by Evaluating Cytokine Release Syndrome in Humanized Mice

  The human immune system is a powerful, intricate defense system that is effective against a wide range of microorganisms and other invading contaminants. However, one’s own immune system can pose a ... read more
• 

  Process Steps from Cell-Line Preparation to Manufacture of Personalized Medicines

  Compliance with Good Manufacturing Practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorization. Likewise, the manufacture of investigational medicinal ... read more
• 

  Large Molecules, Small Batches: Understanding the Sterile Fill-Finish Needs of Pharma’s Emerging...

  It may seem counterintuitive, but the often-reported shortage of large batch CDMOs and the resulting backlogs in production actually may hit small batch manufacturing companies the hardest. The ... read more
• 

  European Pharmacopoeia Approach to Testing for Pyrogenicity

  The texts of the European Pharmacopoeia (Ph. Eur.) play a major role in ensuring the quality of medicines in Europe. They consist in general chapters and monographs, which are mandatory quality ... read more
• 

  The Cloud Does Not Bite!

  Even without the pandemic in place, we were in a challenging time for most traditional pharmaceutical companies. The high competitiveness of the market, increasing international regulatory ... read more
• 

  Validation Strategy for New Recombinant Factor C Users

  This paper presents Roche’s validation strategy of the recombinant factor C (rFC) endotoxin testing method. The validation approach uses statistical non-inferiority hypothesis testing based on spiked ... read more
• 

  Enabling Technologies Consortium: Implementations of Wearable Enhanced Knowledge and Analytics...

  Core tools used for research and development in pharmaceutical laboratories, such as media capture, integration, and electronic notebooks, have not kept pace with the electronic multimedia tools and ... read more
• 

  mRNA: A New Frontier in Vaccines and Medicine

  Vaccines have revolutionized the world’s ability to prevent, mitigate the impact of and, in some cases, eliminate the threat of certain infectious diseases and improve overall health. The clinical ... read more
• 

  Data Integrity in the QC Lab – Reducing the Potential for Human Error in Endotoxin Testing

  Data integrity is of the utmost importance when testing and analyzing products and devices in the Quality Control (QC) laboratory. In an increasingly automated world, demands are also rising in the ... read more
• 

  FDA Withdrawal of Temporary COVID-19 Pandemic Hand Sanitizer Manufacturing Guidelines; Additional...

  All hand sanitizers, whether used by consumers or healthcare professionals, are considered over-the-counter (OTC) drugs that are regulated by the FDA. The most common type of hand sanitizer has ... read more
• 

  USP <1111> Microbial Contamination Risk Factors Re-Visited

  This review article discusses the microbial contamination risk factors presented in USP General Informational Chapter <1111> Microbiological Examination of Non-sterile Products: Acceptance Criteria for ... read more
• 

  An Interview with Kenneth Laderman, PhD. Director of Manufacturing, Eurofins Advantar Laboratories,...

  Eurofins BioPharma Product Testing highlights how it helps clients in the bio/pharmaceutical industry overcome challenges in sterile fill finish manufacturing with a state-of-the-art robotic vial ... read more
• 

  Purification Strategies for Recombinant Therapeutic Proteins

  Many biopharmaceuticals are recombinant proteins obtained by biotechnological processes. In various steps of the pharmaceutical value chain, from drug discovery, to development and manufacturing, to ... read more
• 

  QC Executive Q&A Research and Development of Protein-Based Therapeutics

  As a global provider, Merck offers a wide range of products and services to biopharma. On the analytical side, we have a growing selection of chromatography and sample preparation products for ... read more
• 

  Detection of Compounds Found in an Unapproved Dermal Filler Using Fourier transform Infrared...

  The use of injectable materials for soft-tissue augmentation has been increasing globally (1). The US FDA has approved materials such as calcium hydroxylapatite, poly-L-lactic acid (PLLA), ... read more
• 

  PCR-Based Methodologies to Characterize AAV Gene Therapy Vectors

  Gene therapy is a modality that requires a complex analytical control strategy to ensure safety and efficacy of the drug product. Adeno-associated virus (AAV) is widely used as a vector for ... read more
• 

  Pharmaceutical P.I.N. Points - Patent Innovation News

  The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in October-November 2021. read more
• 

  Learning to Accept the Unacceptable

  A long, long time ago when I was in college, I pledged a fraternity. It was a new fraternity, and me and my six other pledge brothers were the first pledge class. read more