At Synergy Bioscience, we understand that pharmaceutical and bio-pharmaceutical development is a complex process requiring expertise in various fields. Our comprehensive formulation development services cater to a wide range of molecules, including small chemical molecules and large protein molecules such as enzymes, monoclonal antibodies, growth factors, complex glycoproteins, and novel recombinant constructs. Whether you need a standalone service or a comprehensive development program, our team of experts is dedicated to providing tailored solutions
Synergy Bioscience – Mastering Pharmaceutical Dissolution Testing Pharmaceutical dissolution testing stands as a cornerstone in evaluating drug product quality throughout the development and manufacturing stages. This pivotal test gauges the release of a drug’s active substance within a controlled laboratory setting designed to emulate in-vivo conditions. It serves as an indispensable parameter for determining drug product efficacy and safety. In this article, we will explore the importance of dissolution testing and the reasons why Synergy Bioscience emerges as the premier choice
As a vital component of patient safety, endotoxin testing is essential for medical devices, injectables, and their raw materials. Endotoxins, small hydrophobic molecules found in the outer membrane of Gram-negative bacteria, can be released when bacteria die, triggering toxic reactions. Unfortunately, endotoxin testing is sometimes neglected, with many manufacturers relying heavily on sterility testing. However, sterility testing only detects live microorganisms and may fail to identify released endotoxins during the sterilization process validation. The consequences of undetected
Introduction The pharmaceutical industry is a highly regulated sector, with a primary focus on ensuring the safety, quality, and efficacy of medicinal products. One critical aspect of this process is the identification and quantification of extractables and leachables (E&L) in drug products and their packaging. These studies are essential for minimizing potential health risks and maintaining compliance with regulatory guidelines. Synergy Bioscience, a leader in the field, offers comprehensive solutions for E&L analysis that help manufacturers guarantee product safety and meet
Container Closure Integrity Testing (CCIT) is critical to ensuring the safety and efficacy of pharmaceutical, biological, and vaccine products. The adequacy of container closure systems to maintain a sterile barrier against potential contaminants such as microorganisms, reactive gases, and other substances is evaluated through this assay. Synergy Bioscience is a company that specializes in providing state-of-the-art CCIT capabilities with uniquely qualified scientists to exceed client expectations. Proper container closure systems are essential to maintain product and consumer
Synergy Bioscience is at the forefront of harnessing the full potential of orbitrap mass spectrometry, providing cutting-edge solutions for a wide range of applications. This technology has become essential for the chemical characterization of pharmaceutical and biological products, accelerating development pipelines, and improving the quality and efficiency of life-changing therapeutics. In this blog post, we will explore various application areas where Synergy Bioscience’s mass spectrometry solutions shine. 1: Proteomics Applications Synergy Bioscience’s mass spectrometry solutions enable the characterization
Pharmaceutical extractables and leachables testing is a crucial aspect of ensuring drug safety and quality. The process involves assessing potential interactions between primary container-closure systems, packaging components, and the drug dosage form. In this blog, we’ll discuss the importance of such testing and highlight the technical capabilities of Synergy Bioscience, a leader in the field. Why Extractables and Leachables Testing Matters: Extractable are chemical species that
Introduction Pharmaceutical stability studies are an essential component of drug development and regulatory approval. Stability testing allows you to understand how your product behaves under different conditions, such as temperature and humidity, and helps you to determine its shelf life and storage conditions. At Synergy Bioscience, we offer pharmaceutical stability program development and testing services to help you achieve product development needs and regulatory requirements. In this article, we’ll explain the importance of pharmaceutical stability testing and how it
Introduction: Freeze drying, also known as lyophilization, is a process used in the pharmaceutical industry to preserve drugs and other therapeutic products. The process works by removing water from the product and creating a dry, shelf-stable form that can be stored for long periods of time. This is crucial in the development of drugs, as many medications require strict storage conditions to maintain their efficacy and safety. In this article, we will explore the role of freeze drying in the