Whitepapers
Analysis of Residual CHO Host Cell DNA Using qPCR
Background Chinese Hamster Ovary (CHO) cells are widely utilized in the biopharmaceutical industry for the production of recombinant proteins like monoclonal antibody (mAb). CHO cells are selected for the high protein yield. In addition, they can perform human-like post-translational modifications which are important for biological activities and stability for therapeutic proteins. However, removal of host ... Analysis of Residual CHO Host Cell DNA Using qPCR
Disinfectant Efficacy Studies
Background There are multiple strategies employed for controlling the manufacturing environment for the safe manufacture of pharmaceutical products and medical devices. These strategies include engineering controls (e.g. HEPA filtration and air pressure differentials), environmental controls (e.g. gowning procedures and material/personnel transfer processes), and routine disinfection of the cleanroom spaces with the application of disinfectants in ... Disinfectant Efficacy Studies
Development of an mRNA Purity Method by Capillary Gel Electrophoresis (CGE)
Background Large Ribonucleic Acids (RNAs) including messenger RNAs (mRNAs) are promising candidates for therapeutic treatment and vaccines, having generated great interest in the field of vaccination as a safe and efficient alternative to traditional live virus or protein-based vaccines. Unlike traditional vaccines, mRNA can be engineered to carry specific genetic information, which upon delivery into ... Development of an mRNA Purity Method by Capillary Gel Electrophoresis (CGE)
Development of dsRNA Detection by Dot Blot Technique
Background The increasing importance of in vitro transcribed (IVT) mRNA for synthesizing the encoded therapeutic proteins in vivo (as therapeutic proteins or vaccines) demands the manufacturing of pure messenger RNA (mRNA) products. mRNA is synthesized through a four-step process: linear plasmid production, in vitro transcription (IVT), purification and final quality control. It is imperative that ... Development of dsRNA Detection by Dot Blot Technique
Methods for Characterization and Release Testing of Live Biotherapeutic Products
Live biotherapeutic products are characterized by their diversity, which presents challenges for accurate analytical characterization. Comprehensive analysis is necessary to understand microbial composition, functional mechanisms of action, efficacy, and safety. Regulatory considerations and guidelines further add complexity to the characterization and release testing process. This white paper explores methods for the characterization and release testing ... Methods for Characterization and Release Testing of Live Biotherapeutic Products
Strategies of Method Development of Leachables Impurities Analysis Using Liquid Chromatography–Mass Spectrometry
INTRODUCTION The term ‘‘leachables’’ refers to impurities in pharmaceutical products with an origin of the pharmaceutical container closure system in either direct or indirect contact with the formulation [1]. Pharmaceutical regulatory authorities, such as European Medicinal Agency (EMA) and Food and Drug Administration (FDA), periodically issue guidelines on leachables quantitation in pharmaceutical manufacturing and finished ... Strategies of Method Development of Leachables Impurities Analysis Using Liquid Chromatography–Mass Spectrometry
Virtual Audits: Finding opportunity in COVID-19 crisis
Qualification audits have always been routine events for life-science companies, such as pharmaceutical manufacturers. For companies that outsource their testing, audits — complete with onsite visits to laboratory facilities — are traditional practice in terms of maintaining Food and Drug Administration (FDA) compliance. COVID-19’s emergence meant an alternate to the onsite qualification audits was needed. ... Virtual Audits: Finding opportunity in COVID-19 crisis
How BA Sciences Streamlines Method Development and Validation
In the pharmaceutical industry, method development and validation challenges have long had scientists simultaneously working toward streamlining analytical testing methods while upholding GMP quality and meeting method specifications. The challenge is to expeditiously develop an analytical method that will meet the end user’s need while keeping unforeseen problems from arising during method validation, which is ... How BA Sciences Streamlines Method Development and Validation
Data Integrity: A Multifaceted Commitment of Quality
When you consider data used by companies to make decisions, its integrity — and the regular maintenance and commitment to its accuracy — is core to its intrinsic value. Data must be precise to be useful in any productive way, and it must be accurate for the course of its lifecycle. It must be searchable, ... Data Integrity: A Multifaceted Commitment of Quality
Creation of Custom MALDI-TOF Libraries for Microbiome LBP Consortia Products
BA Sciences is a leader in the microbiome industry and working with Live Biotherapeutic Products (LBP). BA Sciences has been leading the industry in cGMP characterization and identification of these LBP products, where the active is a live anaerobic bacterial cell. The Microbiology team at BA Sciences has been working on developing identification, activity, and ... Creation of Custom MALDI-TOF Libraries for Microbiome LBP Consortia Products
An Overview of Dissolution Method Development and Validation for Semisolid Dosage Forms
When most of us think of drug product dissolution testing, images of solid oral dosage forms like capsules and tablets using Apparatus 1 or 2 come to mind. But other dosage forms are also characterized by dissolution, including semisolid forms often used for topical drug delivery. It’s worthwhile to look at some of the things ... An Overview of Dissolution Method Development and Validation for Semisolid Dosage Forms
An Introduction to Dissolution and Available Apparatuses
Dissolution testing has been a customary United States Pharmacopeia (USP) test for solid oral dosage forms for more than four decades and for semisolid oral dosage forms for the last decade. This article provides some background on dissolution testing, then defines USP dissolution apparatus 1 through 7 and provides practical examples of the use of ... An Introduction to Dissolution and Available Apparatuses