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Operational Excellence in Extractables & Leachables
Operational efficiency is critical to the success of extractables and leachables (E&L) studies. In this video, learn how BA Sciences combines experienced scientific leadership, streamlined workflows, and technical expertise to efficiently manage complex E&L programs for pharmaceutical, medical device, and packaging applications. Discover how our structured approach—from sample receipt and extraction through analytical testing ... Operational Excellence in Extractables & Leachables
Drive Better Outcomes Through E&L Collaboration
Successful extractables and leachables (E&L) programs depend on more than analytical testing, they require collaboration across scientific disciplines. In this video, our experts discuss how BA Sciences partners internally with project management, quality, and analytical teams, as well as externally with pharmaceutical companies, medical device manufacturers, and packaging suppliers, to develop efficient, risk-based E&L strategies. ... Drive Better Outcomes Through E&L Collaboration
Understanding Bioassay Types
Bioassay, which stands for biological assay, is a procedure that measures the potency, efficacy, or toxicity of a substance by observing its effects on living tissues, organisms, or cells. Bioassays are a vital part of scientific research as they provide a direct and measurable understanding of how a substance interacts with living systems. As such, they ... Understanding Bioassay Types
What You Give Up When You Outsource to a Large CRO — and What to Look For Instead
When selecting a pharmaceutical CRO testing services partner, size is an easy proxy for capability. Large organizations that offer analytical testing — whether as their primary business or as part of a broader service portfolio — have the infrastructure, the service menus, and the regulatory track records to back that perception. But organizational scale also ... What You Give Up When You Outsource to a Large CRO — and What to Look For Instead
What Analytical Testing Do You Need Before an IND Submission?
For early-stage biotech teams preparing their first Investigational New Drug application, the CMC analytical testing requirements in the Chemistry, Manufacturing, and Controls section are often where timelines stall. FDA does not require commercial-grade data at the IND stage, but it does expect sufficient analytical characterization to demonstrate that your drug substance and drug product are ... What Analytical Testing Do You Need Before an IND Submission?
What Are Extractables and Leachables?
Extractables and leachables, (E&L), are chemical impurities that migrate from delivery devices, packaging, and manufacturing systems into pharmaceutical products. Extractables are compounds that can be released from materials under exaggerated lab conditions, such as exposure to solvents, heat, or extended contact time. Leachables, are compounds that enter the drug product under normal manufacturing, storage, or ... What Are Extractables and Leachables?
Comparing Bioburden Testing and Sterility Testing
When it comes to microbial quality assurance (MQA), it’s a proactive, comprehensive system that is in place within the manufacturing, food, cosmetic, and pharmaceutical industries to ensure safe, sterile products that are free of harmful microorganisms. This process involves adhering to the Hazard Analysis and Critical Control Points (HACCP) standards that oversee proactive measures designed ... Comparing Bioburden Testing and Sterility Testing
Environmental Monitoring and Critical Utilities
BA Sciences supports environmental monitoring with a comprehensive range of capabilities across both cleanroom environments and critical utilities. Our team collects non-viable and viable air samples, as well as monitors parameters such as hydrocarbons and dew point to ensure environmental control. In addition, we assist with contamination control investigations through targeted, case-specific sampling, including swab ... Environmental Monitoring and Critical Utilities
Environmental Monitoring Support at BA Sciences
BA Sciences offers flexible environmental monitoring solutions tailored to each stage of your program. From large-scale Environmental Monitoring Performance Qualification (EMPQ) studies, designed to qualify new controlled environments for production, to ongoing routine monitoring on a weekly, monthly, or quarterly basis, our team adapts to your specific needs. Whether you’re building a new facility or ... Environmental Monitoring Support at BA Sciences
Outsourcing your Environmental Monitoring Program?
Outsourcing Environmental Monitoring (EM) allows your team to stay focused on what matters most—advancing your products and strategic initiatives. With a fully turnkey approach, BA Sciences manages every aspect of your EM program, from documentation and sampling to results reporting and data trending, delivering reliable support and actionable insights every step of the way. ... Outsourcing your Environmental Monitoring Program?
Environmental Monitoring at BA Sciences
Why Environmental Monitoring Matters More Than Ever In today’s highly regulated pharmaceutical landscape, environmental monitoring (EM) is no longer just a compliance requirement—it’s a critical component of product quality, patient safety, and inspection readiness. As regulatory expectations continue to evolve, companies must move beyond simply “checking the box” and instead adopt a proactive, data-driven approach ... Environmental Monitoring at BA Sciences
What Is Method Transfer in Pharmaceuticals?
In pharmaceutical programs, method transfer is the documented process of demonstrating that an analytical procedure can be performed with equivalent performance at a second laboratory.
What Is Pharmaceutical Testing? Role in Drug Quality and Safety
Pharmaceutical testing refers to the analytical methods used to evaluate the quality, purity, identity, and microbiological status of drug substances and finished drug products. These evaluations establish whether materials meet predefined specifications and whether manufacturing processes remain in control under cGMP requirements. Pharmaceutical testing operates alongside—but is distinct from—clinical development. While clinical trials examine safety and efficacy in human populations, pharmaceutical testing focuses ... What Is Pharmaceutical Testing? Role in Drug Quality and Safety
What Is Microbiology Testing? Importance and Applications
Microbiology testing encompasses the analytical approaches used to examine the microbial content of materials, utilities, and controlled environments. These evaluations determine whether organisms are present, quantify microbial loads when required, and characterize isolates recovered during routine monitoring or investigations. The resulting data form part of the evidence used to assess whether manufacturing processes remain within their intended microbial control ranges. In ... What Is Microbiology Testing? Importance and Applications
What Is Endotoxin Testing, and Why Does It Matter in Regulated Manufacturing?
Endotoxin testing is a core component of microbial quality control for parenteral drugs, implantable and blood-contacting medical devices, and high-purity water systems. Endotoxins—lipopolysaccharides found in the outer membranes of Gram-negative bacteria—are potent pyrogens and must be controlled at levels defined by compendial and regulatory requirements. In cGMP environments, endotoxin testing helps confirm that materials, processes, and finished products meet ... What Is Endotoxin Testing, and Why Does It Matter in Regulated Manufacturing?
What Is Stability Testing in Pharmaceutical Products?
Stability testing evaluates how a drug substance or drug product performs over time when exposed to defined environmental conditions. These studies generate the data used to establish shelf life, justify labeled storage recommendations, and determine whether a product maintains its quality attributes throughout its lifecycle. Regulatory expectations from the FDA and the International Council for ... What Is Stability Testing in Pharmaceutical Products?
Understanding Microbial Identification
Microbial identification is the process of determining the identity of microorganisms present in a sample, typically at the genus or species level. In pharmaceutical, biopharmaceutical, and medical device manufacturing, identification supports contamination investigations, environmental monitoring programs, raw material evaluation, and overall microbial control strategies. These activities help organizations understand the significance of recovered isolates and assess whether ... Understanding Microbial Identification
Guide to Sterility Testing for Pharmaceuticals
Sterility testing is a required component of pharmaceutical and medical device manufacturing, supporting the release of sterile products and compliance with regulatory expectations. In regulated environments, sterility is statistically inferred rather than proven absolutely. Compendial sterility tests are therefore conducted alongside validated sterilization processes and controlled manufacturing conditions to assess whether products meet the standards defined for sterile ... Guide to Sterility Testing for Pharmaceuticals
What Is Analytical Development in Pharmaceuticals?
Analytical development sets the framework for how a drug substance and product will be assessed throughout its lifecycle. Methods are designed and validated to meet expectations from the FDA, EMA, and ICH, ensuring that measurements of identity, strength, purity, and stability are scientifically sound and appropriate for regulatory use. Because analytical activities integrate directly with formulation and process development, they help establish specifications, ... What Is Analytical Development in Pharmaceuticals?
How to Get FDA Approval: Navigating Regulatory Compliance
FDA approval for drugs and biologics is not a single event, but a regulated process that spans development, manufacturing, and post-market oversight. Approval decisions are based on the cumulative evaluation of scientific data, manufacturing controls, and ongoing compliance with applicable FDA requirements. For organizations developing regulated products, understanding how these elements interact helps frame regulatory ... How to Get FDA Approval: Navigating Regulatory Compliance
What Is Plasmid DNA? Understanding Its Role in Biotechnology
Plasmid DNA is a small, circular, double-stranded DNA molecule that exists independently of the main bacterial chromosome and replicates autonomously using host cellular machinery. Plasmids often carry genes that confer selective advantages—such as antibiotic resistance or metabolic capabilities—but are not required for basic cellular survival. Plasmid DNA differs from chromosomal DNA in several important ways: Functional role: Chromosomal ... What Is Plasmid DNA? Understanding Its Role in Biotechnology
What Is ISO/IEC 17025? A Guide to Laboratory Accreditation
ISO/IEC 17025 is an international standard that defines the competence requirements for testing and calibration laboratories. It is sometimes described as a “certification,” though it formally establishes laboratory accreditation based on demonstrated technical competence. Laboratories accredited to ISO/IEC 17025 operate under a quality management system designed to support impartiality, traceability, and ongoing compliance. The standard ... What Is ISO/IEC 17025? A Guide to Laboratory Accreditation
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