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What Are Advanced Therapeutic Medicinal Products (ATMPs)?
Advanced Therapeutic Medicinal Products (ATMPs) are a class of therapies that include gene therapy, somatic cell therapy, and tissue-engineered products. Designed to repair, replace, or modify biological functions at their source, they differ from traditional medicines that primarily manage symptoms. For researchers, quality teams, and regulatory professionals, understanding how ATMPs are defined, classified, and evaluated helps support development, ... What Are Advanced Therapeutic Medicinal Products (ATMPs)?
Guide to USP ‹661› Series for Plastic Packaging
Pharmaceutical packaging directly influences the safety, stability, and overall performance of drug products. The USP <661> series defines how plastic materials and packaging systems must be evaluated to confirm that they are appropriate for pharmaceutical use. For quality, regulatory, and product development teams, the standard is a key reference for: identifying packaging-related chemical migrants, assessing how materials interact ... Guide to USP ‹661› Series for Plastic Packaging
How to Calculate Endotoxin Limits
Endotoxin contamination remains a major quality concern in pharmaceutical and medical device production. Unlike sterility testing, which verifies the absence of viable microorganisms, endotoxin testing targets pyrogenic substances that remain even after sterilization. These lipopolysaccharides are heat-stable and difficult to remove once present. For manufacturers, knowing how to calculate endotoxin limits and applying validated test methods are necessary steps to meet global regulatory expectations ... How to Calculate Endotoxin Limits
What Is Raw Material Testing? Standards for Quality Assurance
Raw material testing is the process of verifying the identity, purity, composition, and quality of materials before they are used in pharmaceutical or medical device manufacturing. In regulated environments, these evaluations confirm that incoming materials meet predefined specifications and are suitable for cGMP- or quality-system–controlled production. For pharmaceutical manufacturers, raw material testing supports: confirmation that ingredients ... What Is Raw Material Testing? Standards for Quality Assurance
What Is Gene Therapy?
Gene therapy is a treatment approach that modifies, replaces, or regulates genes within a patient’s cells to address the underlying cause of disease. Instead of targeting symptoms, these therapies work at the molecular level by: replacing a nonfunctioning or mutated gene with a functional copy, inactivating a gene that is producing harmful effects, or introducing a ... What Is Gene Therapy?
What Is Pharmaceutical Release Testing?
Pharmaceutical release testing determines whether each batch of a drug is ready for distribution. Before any product is cleared for use, it must meet defined specifications for identity, strength, purity, and overall quality — confirmed through scientifically validated laboratory analysis. For manufacturers, release testing provides the final, evidence-based confirmation that a batch performs as intended ... What Is Pharmaceutical Release Testing?
What Is Analytical Testing in Pharmaceuticals?
Analytical testing is the set of scientific procedures used to evaluate the identity, strength, purity, stability, and overall quality of pharmaceutical products. These studies confirm that every batch released to patients performs as intended — and that no harmful levels of impurities or contaminants are present. Every product on the market has analytical data behind ... What Is Analytical Testing in Pharmaceuticals?
What Is Non-Compendial Testing?
Quality teams routinely support products that move faster than pharmacopoeial standards can update. When a therapy relies on novel excipients, advanced delivery systems, or biological components, there may be no official method in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or Japanese Pharmacopoeia (JP) to verify identity, purity, or stability. Non-compendial methods are ... What Is Non-Compendial Testing?
Sterile vs Non-Sterile Testing: Requirements for Pharmaceutical Quality
Pharmaceutical products are developed within environments that are tightly controlled to protect patient safety and maintain regulatory compliance. A key distinction in this control framework is whether a product must remain sterile—completely free of viable microorganisms—or whether it can be produced within a non-sterile environment that allows a defined and monitored microbial presence. This difference ... Sterile vs Non-Sterile Testing: Requirements for Pharmaceutical Quality
Current Good Manufacturing Practice (cGMP): Key Principles
Pharmaceutical manufacturing operates under Current Good Manufacturing Practice (cGMP) — the U.S. Food and Drug Administration (FDA) framework that governs the quality, safety, and consistency of every product released to market. These regulations require that all materials, processes, and facilities meet strict standards to protect patients from contamination, dosing errors, and substandard ingredients. Since its ... Current Good Manufacturing Practice (cGMP): Key Principles
What Is Compendial Testing?
Compendial testing verifies product quality, consistency, and compliance across all stages of pharmaceutical manufacturing. It refers to standardized laboratory procedures described in recognized pharmacopoeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). Through compendial testing services, laboratories confirm that: Raw materials and APIs meet defined identity and purity ... What Is Compendial Testing?
cGMP vs GMP: Key Differences in Pharmaceutical Manufacturing
Pharmaceutical manufacturers operate under rigorous quality frameworks designed to ensure that every product reaching patients is safe, effective, and consistent. Two of the most important frameworks are Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (cGMP). While the two share the same foundation, cGMP builds on those standards through advances in technology, automation, and ... cGMP vs GMP: Key Differences in Pharmaceutical Manufacturing
Ready to Elevate Your Analytical Testing?
Explore how BA Sciences can support your analytical testing needs. We’re committed to delivering fast, reliable results backed by over 35 years of industry expertise and a passion for scientific excellence. Now is the perfect time to partner with a lab that understands your urgency, invests in cutting-edge technologies, and provides dedicated, personalized service every step of ... Ready to Elevate Your Analytical Testing?
Step Inside BA Sciences: Watch Our Facility Tour & Plan Your Visit
Have you ever visited BA Sciences? We’d love to give you an exclusive look at our facility! Let’s plan a visit to our 60,000 sq ft lab located just outside the world’s leading biotech hub. We’re continuously expanding and investing in cutting-edge technology and top talent to meet even the most complex analytical needs. Our ... Step Inside BA Sciences: Watch Our Facility Tour & Plan Your Visit
Discover Why Leading Life Science Companies Have Been Trusting BA Sciences Since 1987
Since 1987, BA Sciences has been a trusted partner for life science companies worldwide, delivering exceptional cGMP-compliant analytical testing services. We are dedicated to providing results you can rely on—timely, accurate, and tailored to your specific needs. At BA Sciences, we believe great service goes beyond just analysis. Each client is assigned a dedicated project manager who works ... Discover Why Leading Life Science Companies Have Been Trusting BA Sciences Since 1987
Unmatched Expertise & Innovation in Analytical Testing
At BA Sciences, our team isn’t just highly skilled—they are relentless in their pursuit of excellence. With deep knowledge of regulatory expectations and extensive experience in analytical requirements for drug development, we are redefining standards in advanced analytical services. We’re dedicated to breaking down barriers and building new benchmarks across a wide range of services, ... Unmatched Expertise & Innovation in Analytical Testing
Unwavering Commitment to Excellence & Seamless Project Delivery
At BA Sciences, excellence isn’t just a goal—it’s our standard. We continuously refine our workflows through a dedicated improvement program to reduce turnaround times and guarantee on-time project completion. Our project management team, comprised of industry professionals with deep technical expertise, ensures you receive consistent, clear communication every step of the way. Our team isn’t ... Unwavering Commitment to Excellence & Seamless Project Delivery
Accelerate Your Project’s Journey to Market with BA Sciences – Your Trusted Analytical Partner
In the fast-paced world of medical innovation, you need a partner who can keep up—delivering rapid, reliable results while navigating complex regulations and tight timelines. We’re here to help. At BA Sciences, we have over 35 years of industry-leading experience, we’re more than just a lab—we’re your dedicated partner committed to accelerating your product’s journey ... Accelerate Your Project’s Journey to Market with BA Sciences – Your Trusted Analytical Partner
Partner with BA Sciences – Your Agile, Analytical Testing Solution
At BA Sciences, we understand the importance of reliable, high-quality analytical testing in bringing your innovative products to market. As a privately owned company with over 35 years of experience, we’ve built our reputation on a commitment to agility, scalability, and technical excellence—setting a new standard in the industry to support your success. Strategically located ... Partner with BA Sciences – Your Agile, Analytical Testing Solution
Unlock Faster Results & Unmatched Expertise with BA Sciences
At BA Sciences, we understand that driving medical innovation and improving patient outcomes require precision, speed, and reliability. As your company pushes the boundaries of therapeutic advancements, you need an analytical testing partner that can keep pace with your ambitious goals. That’s where we come in. With over 35 years of experience, BA Sciences ... Unlock Faster Results & Unmatched Expertise with BA Sciences
BA Sciences Unveils New Facility Video Showcasing Innovation and Commitment to Excellence
BA Sciences is excited to announce the release of a new video that offers an inside look at our state-of-the-art facility and the exceptional talent behind our mission. Spanning over 60,000 square feet, our facility is central to our role as a leader in the life sciences industry, providing industry-leading solutions and services. The video ... BA Sciences Unveils New Facility Video Showcasing Innovation and Commitment to Excellence
Over 35 Years Of Excellence: Year One of BA Sciences
It’s hard to believe that it has already been a year since we took on our new identity as BA Sciences—what an incredible year it has been! Our bold new identity has propelled us to continue making a profound impact in the life sciences industry. As your premier cGMP analytical testing laboratory, we’re dedicated to ... Over 35 Years Of Excellence: Year One of BA Sciences
Director’s Corner : Stephanie Smith
Stephanie Smith joined the BA Sciences team in April 2024, bringing with her a Bachelor of Science in Zoology from North Carolina State University (NCSU). Prior to her studies at NCSU, Stephanie pursued Adult Health Nursing at East Carolina University. Her professional journey began at Pitt Memorial Hospital, where she gained experience as a CNA ... Director’s Corner : Stephanie Smith
Boston Analytical Rebrands as BA Sciences
Setting the Standard for Excellence in Global Life Sciences Analytical Testing Salem, NH – March 4, 2024 – Since its founding in 1987, Boston Analytical has been a trusted provider of high-quality analytical testing services to life science companies worldwide. With a commitment to excellence, compliance, and innovation, the company has established itself as a ... Boston Analytical Rebrands as BA Sciences