Industries
Services

Pharmaceutical & Biopharmaceutical Development Services

EAG brings unparalleled expertise to the development and commercialization of small molecule drugs, biopharmaceuticals, antibody-drug conjugates (ADCs), drug-device combination…

EAG brings unparalleled expertise to the development and commercialization of small molecule drugs, biopharmaceuticals, antibody-drug conjugates (ADCs), drug-device combination products and other therapies. From designing IND-enabling studies to delivering full CMC analytical and QC support, we join your R&D team as a true partner. EAG scientists take time to understand both your commercial goals and the unique characteristics of your compound. We provide expert guidance to balance regulatory expectations with expediency and cost, and approach technical challenges with flexibility and resolve.

Materials Testing & Analysis

When it comes to understanding the physical structure, chemical properties and composition of materials, no scientific services company offers the breadth of experience, diversity…

When it comes to understanding the physical structure, chemical properties and composition of materials, no scientific services company offers the breadth of experience, diversity of analytical techniques or technical ingenuity of EAG. From polymers to composites, thin films to superalloys—we know how to leverage materials sciences to gain a competitive edge. At EAG, we don’t just perform testing, we drive commercial success—through thoughtfully designed investigations, technically superior analyses and expert interpretation of data.

Environmental Testing & Regulatory Compliance

Having helped develop the test methods that shape current regulatory guidelines, EAG chemists, biologists and toxicologists have evaluated the environmental impact of thousands of…

Having helped develop the test methods that shape current regulatory guidelines, EAG chemists, biologists and toxicologists have evaluated the environmental impact of thousands of active ingredients and formulations—from pesticides and pharmaceuticals to industrial chemicals and consumer products. Whether you are exploring “what if” scenarios, registering a new active ingredient or formulation, responding to a data call-in or seeking to understand the latest guidance, turn to EAG for technical excellence, sound advice, GLP-compliant study execution and expert interpretation.

Microelectronics Test & Engineering

Whether connecting the internet of things, guiding surgical lasers or powering the latest smart phone, integrated circuits and microelectronics touch nearly every aspect of human…

Whether connecting the internet of things, guiding surgical lasers or powering the latest smart phone, integrated circuits and microelectronics touch nearly every aspect of human life. In the world of technology, innovation and continuous improvement are imperatives—and being able to quickly and reliably test, debug, diagnose failures and take corrective action can make the difference between a doomed product launch and building a successful global brand. EAG offers you the world’s largest and most diverse collection of specialized analytical instrumentation, capacity to perform a variety of microelectronic tests in parallel, and the multi-disciplinary expertise required to draw true insight from data.

Custom Synthesis & Radiolabeling

No contract service provider has more experience performing custom synthesis and producing isotopically labeled compounds to support product development in life science, chemical…

No contract service provider has more experience performing custom synthesis and producing isotopically labeled compounds to support product development in life science, chemical and related industries than we do. From 14C and 3H radiolabeled clinical trial materials synthesized under cGMP, to stable-labeled active ingredients for metabolism and environmental fate/effects testing, turn to EAG. We have extensive experience with multi-step and other complex synthesis projects, and our comprehensive, in-house analytical services ensure quick turnaround of purity and structural confirmation.

Crop Biotechnology & Development

EAG combines biotechnology and protein characterization expertise with more than 50 years' experience analyzing chemical compounds in plant and environmental matrices to address…

EAG combines biotechnology and protein characterization expertise with more than 50 years’ experience analyzing chemical compounds in plant and environmental matrices to address the growing needs of the biotechnology crop industry. We offer a wide range of techniques required to fully characterize the event insertion and expressed proteins, as well as the various studies required to confirm the food, feed and environmental safety of products that represent the trait. From early-stage protein confirmation to GLP-compliant EDSP and allergenicity testing, we help you make faster, more informed development decisions and comply with evolving global regulations of genetically engineered crops.

Litigation Support & Expert Testimony

When you need solid science and investigative engineering to address product failures, inform legal strategy, protect intellectual property or address product liability disputes,…

When you need solid science and investigative engineering to address product failures, inform legal strategy, protect intellectual property or address product liability disputes, turn to EAG. We’ve provided technical consulting, analysis and expert testimony for hundreds of cases involving the aerospace, transportation, medical device, electronics, industrial and consumer product industries. Our team of experts understands the legal process and your need for responsiveness, effective communication, scientifically defensible opinion and confidentiality. From professional consulting to data review to trial preparation and expert witness testimony, ask EAG.

Techniques

Chromatography

Using an array of advanced separation techniques and innovative technology, we conduct highly precise analytical chromatography for various industries. Whether you want a closer…

Using an array of advanced separation techniques and innovative technology, we conduct highly precise analytical chromatography for various industries. Whether you want a closer look at the purity of your pharmaceutical or need to better understand an agrochemical’s components, EAG has the expertise to separate and evaluate any compound.

Mass Spectrometry

Need to evaluate the molecular structure of a compound or identify its origins? EAG knows how. With state-of-the-art tools, we can separate, vaporize and ionize the atoms and…

Need to evaluate the molecular structure of a compound or identify its origins? EAG knows how. With state-of-the-art tools, we can separate, vaporize and ionize the atoms and molecules in almost any pure or complex material to detect and obtain mass spectra of the components. We rely on decades of experience in mass spectrometry to provide our clients with precise analyses and the best detection limits.

Imaging

EAG is a world leader in high-resolution imaging down to the atomic level. We offer unmatched analytical know-how, generating extremely detailed surface and near surface images…

EAG is a world leader in high-resolution imaging down to the atomic level. We offer unmatched analytical know-how, generating extremely detailed surface and near surface images for various industries, from consumer electronics to nanotechnology. Using state-of-the-art equipment and innovative techniques, we conduct expert imaging to aid in failure analysis, dimensional analysis, process characterization, particle identification and more. If you want to investigate a material with angstrom scale resolution, you can count on EAG to get the job done quickly and precisely.

Spectroscopy

EAG offers a vast array of spectroscopic techniques to clients in various industries, from defense contractors to technology pioneers. We combine unparalleled expertise and…

EAG offers a vast array of spectroscopic techniques to clients in various industries, from defense contractors to technology pioneers. We combine unparalleled expertise and methodology with cutting-edge technology to analyze your organic, inorganic, metallic and composite materials for identification, compositional, structural and contaminant information. Whether you need expert spectroscopic analysis to improve your production process or to surmount a technical challenge, EAG is up to the task.

Physical/Chemical Characterization

Need to identify your unique material? Want to analyze the thermal properties of a sample, or measure the success of a process step? If it has to be done quickly and it has to be…

Need to identify your unique material? Want to analyze the thermal properties of a sample, or measure the success of a process step? If it has to be done quickly and it has to be done right, you can count on EAG. We offer a range of adaptable techniques and innovative methods to evaluate the physical and chemical characteristics of any compound. Our highly precise testing and analytical services will improve your production process, expedite R&D and help you conquer any technical challenge.

About

A Global Scientific Services Company

One of the most respected names in contract research and testing, EAG Laboratories is a global scientific services company operating at the intersection of science, technology and…

One of the most respected names in contract research and testing, EAG Laboratories is a global scientific services company operating at the intersection of science, technology and business. The scientists and engineers of EAG apply multi-disciplinary expertise, advanced analytical techniques and “we know how” resolve to answer complex questions that drive commerce around the world.

Our Customers

Science and technology transcend industry boundaries, and so does demand for EAG’s expertise. We partner with companies across a broad spectrum of high-tech, high-impact and…

Science and technology transcend industry boundaries, and so does demand for EAG’s expertise. We partner with companies across a broad spectrum of high-tech, high-impact and highly regulated industries. We help our customers innovate new and improved products, investigate manufacturing problems, perform advanced analyses to determine safety, efficacy and regulatory compliance, and protect their brands.

Our Company Culture

EAG’s corporate culture is firmly rooted in four guiding principles: “foster a growth mindset,” “find a better way,” “earn more loyal customers,” and “win…

EAG’s corporate culture is firmly rooted in four guiding principles: “foster a growth mindset,” “find a better way,” “earn more loyal customers,” and “win together.” Across all of our 20+ locations, you will find a true passion for science and the power of science to improve the world we live in. Hear what some of our ~1200 scientists, engineers and support personnel say about what it means to be part of EAG Laboratories.

Careers

EAG is growing, and we are always looking for talented, problem-solving oriented individuals to join our company. If you have a “we know how” spirit, we want to hear from you.…

EAG is growing, and we are always looking for talented, problem-solving oriented individuals to join our company. If you have a “we know how” spirit, we want to hear from you. Browse current openings now, and re-visit our careers page often.

How do you make better development decisions faster?

The ABC’s of Reference Standard Management

WHITE PAPER

Harley E. Wilcox, MBA, Senior Scientific Advisor

Reference standards play a critical role in pharmaceutical drug development from preclinical to commercial analytical support. Bioanalytical methods often require internal, metabolite, and active ingredient standards in support of method validation and GLP testing. Standards that support cGMP testing such a API impurities are introduced during clinical trial manufacturing of drug substance and drug product. Managing CoAs (Certificate of Analysis), inventory and supplies to external users, are critical to avoiding delays in drug development.

Analytical reference standard ad

Here we profile reference standard management and discuss types of standards, standard via synthesis, officially-sourced standard, suppliers, characterization, and impurity testing. In addition, we will discuss standards storage, retesting and sample administration.

TYPES OF STANDARDS

Officially-sourced standards are purchased from pharmacopeia, NIST or other recognized sources. CoAs are provided but label information and certificates provides statements of purity. The USP standards do not have a use or retest date but are listed as current lot or previous lot. A previous lot designation implies a use period will be assigned. The user of USP standards is responsible for determining if a standard is a current lot or previous lot. If a test article has an issued monograph it is expected that available standards would be used.

In-house prepared standards are obtained from synthesis or in some cases isolation. Synthesized standards scheduled for certification should have a synthesis summary or synopsis prepared and traceable to the lot number and other laboratory documents such as notebooks.

Primary standards Primary reference standards should have a purity of 99.5 percent or higher if reasonable.  Reference standards are typically sourced from API with additional purification.  Lower purity is acceptable if additional purification steps do not improve purity. It is not uncommon to lose 20 percent or more of the initial material during purification which may include large scale chromatography or multiple recrystallization. A primary standard has been well characterized with orthogonal methods, and purity testing for several types of impurities.

For initial identification, impurities of interest are often isolated initially from API chromatography. Once impurity structures are known, a unique synthesis scheme is typically required to prepare adequate quantities for further characterization and purity assessment.

Secondary standards Secondary standards have been tested against a primary standard to establish a use purity.

Reference Material Reference materials are used for non-quantitative testing such as retention time marker.

SAMPLE STORAGE

Non-official sourced standards may be subdivided or fractionated into similar type containers for ready shipping to other labs or vendors. Typically, the subdivided containers contain quantities for limited use or to satisfy the receiving sites’ needs through the retest period. Both primary standard containers and fractionated containers are stored together to allow for requalification for all containers. Thus, when a new CoA is generated, the primary container and fractionated samples are qualified and relabeled upon new CoA. Typically, fractionated samples shipped to other sites are not qualified upon retest. Fractionated limits risk by limited the handling of the primary container.

The storage condition for an individual standard should be based on the stability profile. Storage conditions include temperature (-80 ºC to RT), protection from light and ambient humidity.

Standard handling information should be documented to ensure the user understands how to dispense and use. For example, moisture or light sensitive standard may require special handling.

RETESTING AND RETEST DATING

One common question for new reference standards is how to establish a retest date. If limited stability information is available for the API, one may consider an initial 6M (or sooner) retest date. API with more established stability data typically have longer retest periods i.e. 12M.. Longer retest periods may be incorporated if supported by data.

A retesting notification system, electronic or other, is essential to avoid lapse in CoAs. A 60-day notification of retest due date is recommended to allow adequate time for protocols, testing and documentation.

CHARACTERIZATION AND PURITY 

Primary standard qualification requires extensive characterization/identification as well as purity testing.  The characterization will assist in determining absolute structural configuration.

Stuctural characterization techniques utilized include:

  • Infrared Spectroscopy
  • Mass Spectrometry
  • NMR Spectroscopy
  • UV Spectroscopy
  • XRD

NMR techniques may include 1H, 13C, , NOESY, COSY, DEPT, TOSCY, and DEPT. X-ray characterization requires a single crystal of specific size.

Purity assessment may include volatile impurities, organic impurities, and inorganic impurities.

  • Nonvolatile/semivolatile Organic Impurities-HPLC
  • Inorganic Impurities—ROI, and ICP
  • Volatile Impurities—KF Water, GC, TGA, and LOD
  • Qualitative Testing—DSC, XRPD, melting point, specific rotation
  • Stoichiometry Testing -quantitation of counter ion, salts of active moiety

Standards used for non-quantitative analysis may require less testing to exclude e.g. solvents, metals and water.

EAG LABORATORIES REFERENCE STANDARD MANAGEMENT PROGRAM OVERVIEW

One current program managed over 10 years.

  • Utilizes LIMS where applicable
  • Extensive experience in sample shipments
  • Each program can be designed to fit the client’s systems and needs
  • Up to 100-200 gram scale synthesis

Reference Standard Fractionation:

  • LIMS login
  • Managed by dedicated Sample Administration Team
  • Control re-labeling upon retesting with replacement of LIMS label and verification
  • Sub Samples Stored with the Master container

 Reference standard Receipt:

  • Processed by SOP’s for time of sample log in and subsequent shipment processing for entry into LIMS: Sample administration Team (SAT)
  • Samples received needs clear identifier as a reference standard, lot, storage conditions, retest date, product etc.
  • Shipping information retained