Whitepapers
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
A Primer on Photostability in the Development of Pharmaceuticals
The storage conditions of a drug product can put it under a lot of stress. Environmental conditions, such as light, can have a huge impact on how well a drug works and whether the drug is breaking down and forming toxic degradation products. The shelf life of a drug product depends a great deal on ... A Primer on Photostability in the Development of Pharmaceuticals
Nitrosamines Analysis
Since the FDA’s discovery of nitrosamines impurities, which led to the voluntary recall of valsartan in 2018, the pharmaceutical industry has undertaken a thorough investigation of this class of compounds to ensure patient safety. Since nitrosamines are a class of organic compounds identified as probable human carcinogens, the potential presence of these compounds in drug ... Nitrosamines Analysis