	Celerion, a clinical research services company, announced it is expanding its specialized high-resolution mass spectrometry profiling capabilities in order to continue aiding sponsors throughout the process of drug metabolites becoming approved therapeutic products.

	According to a June 5, 2020 press release, the company has designed a bioanalytical offering that supports drug development, from 

 metabolite identification to human absorption, distribution, metabolism, and excretion (ADME) profiling studies using the SCIEX TripleTOF 6600+ instrumentation along with the v.ARC 3 online radio detection and software packages.

	“Celerion is pleased to provide this much-needed service to our bioanalytical clients. This metabolite identification capability rounds out our well-known ADME Human Mass Balance offering. We can now continue to work with our clients to define the radiometabolite profile of their drug following human administration to complement earlier 

 data and further guide drug development,” said Petra Struwe, PhD, executive director of the Zurich bioanalytical laboratory, in the press release.

	“These advances enable our clients to rapidly identify and quantify metabolites from human mass balance studies to better understand the potential metabolic breakdown products of novel investigational compounds which may contribute to suboptimal pharmacokinetics and potentially toxic metabolites or even drug-drug interactions,” added Ray Farmen, PhD, vice-president of global bioanalytical sciences at Celerion, in the press release.

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The company has designed a bioanalytical offering that supports drug development, from in-vitro metabolite identification to human ADME profiling studies.

Celerion Expands its High-Resolution Mass Spectrometry Profiling Capabilities

	MilliporeSigma announced the launch of the new MyMilli-Q online solution for its Milli-Q water purification systems. The online program gives customers the opportunity to access their laboratory’s water system remotely while supporting online contract management, remote system monitoring and servicing, and data traceability.

	Located in one centralized web-based location, users are able to track service history and consumable orders, schedule maintenance visits, and renew contracts, according to a June 18, 2020 press release. Additionally, the solution can be used with the Milli-Q Connect remote services for real-time, remote water system and quality monitoring.

	“MilliporeSigma recognizes that, now more than ever, laboratory personnel need the ability to remotely monitor and manage their systems in order to help ensure upkeep and workflow continuity. The ability to manage service contracts online will help facility managers, lab managers, and purchasers streamline the care of their Milli-Q water systems,” the company said in the press release.

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The new MyMilli-Q gives customers the opportunity to access their laboratory’s water system remotely while supporting online contract management, remote system monitoring and servicing, and data traceability.

MilliporeSigma Launches Online Solution for its Water Purification Systems

	The imperative to accelerate the development and production of new therapies and vaccines to treat patients infected by the COVID-19 virus has prompted a steady wave of new advisories from FDA on strategies for assessing new therapies and for ensuring quality products. The pandemic has required revisions in how companies maintain safe operating practices and how research sponsors assess and implement changes necessary to fit this new reality.

	One result of the coronovirus pandemic is an emphasis at FDA on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future. In recent months, the agency has devised a more streamlined process for guidance development due to pressures to address R&D issues quickly, observed Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), at the June 2020 virtual annual meeting of the Drug Information Association (DIA). In considering likely changes in operations from the pandemic, Marks noted that FDA is moving away from what in the past has been a “challenging and somewhat tortured” process, where it often took two or three years of deliberations to devise a guidance document-with the result that the resulting advisory was “often outdated by the time it is published,” he commented. Now FDA staffers resolve their differences quickly, he said, resulting in a shorter process that often produces fresher and more useful documents.

outlines how manufacturers should ensure that workers who become infected by COVID-19

 do not compromise drug products or quality standards. FDA advises manufacturers to evaluate how the coronovirus increases risk of contamination under existing manufacturing controls and what kind of restrictions should be placed on sick workers.

 for developing drugs to treat bacterial pneumonia, in both community and hospital settings, and for ventilator-associated conditions. These final guidances offer new approaches for study randomization, patient enrollment, primary endpoints, and intravenous drug formulations to treat these conditions.

	Also important to manufacturers was a final guidance published in March 2020 in response to concerns about increased drug shortages due to the pandemic. FDA updated policies for manufacturers to notify the agency of any 

anticipated discontinuance or interruption 

2020 provide more flexibility for pharmaceutical compounders to respond more readily to shortages in needed drugs. And a draft guidance issued in May 2020 contains recommendations for permitted daily exposures to three residual solvents, developed by experts collaborating under the International Council for Harmonisation (ICH). The 

solicits comments from manufacturers and other experts as part of the process for updating the ICH Q3C guideline on permitted daily exposures to such substances. 

	FDA continues to update an overarching guidance published in March 2020 on how sponsors and researchers can modify clinical trials to adjust effectively to health care realities related to the pandemic. Recent additional guidance address the 

use of alternative laboratory or imaging centers

 and implementing video conferencing in ongoing studies. FDA also has advised on how and when sponsors should report serious adverse events related to a trial and on accepted changes to informed consent practices to facilitate the use of e-signatures and remote assessments during the pandemic.

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FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future. 

FDA Speeds New Guidance Development to Inform Manufacturing and Research During Pandemic

Bioanalytical studies are an important aspect in biologic drug development because data from these studies are needed to define the characteristics of potential new biologics. Bioanalyses data are also an important inclusion in regulatory filings, driving the need for outsourcing partners with in-depth bioanalytical experience and experience interacting with regulatory authorities. 

 spoke with Robert Kernstock, PhD, director, Immunoassay Laboratory Services at ICON, and Neelanjan Bose, PhD, Director of Bioanalytical Chemistry at Emery Pharma, both contract research organizations (CROs), about the need for bioanalytical testing programs and regulatory strategies for potential new biologics.

 Why is it so important to conduct bioanalytical studies during the development process of a new biological therapeutic?

 Bioanalytical studies, which are designed to provide estimates for concentration of drugs and biologics in pre-clinical and clinic studies of the therapeutic molecule or their metabolites, are critical for various aspects of human clinical pharmacology, studies related to bioavailability (BA)/bioequivalence (BE) evaluation, and some nonclinical studies requiring concentration information for pharmacokinetics, toxicokinetics, or biomarkers. Bioanalytical work serves to supplement pivotal studies and aid in the decision-making process for approval, safety, and/or labeling of a drug or biologic; in short, without proper bioanalytical data, the therapeutic product would not be approved. 

 Beyond the regulatory requirements for conducting bioanalytical studies, the scientific importance of the data that these assays generate is invaluable. Bioanalytical assays provide information on certain safety aspects of the therapeutic in determining the maximum tolerated dose. Pharmacokinetic (PK) scientists use the data to determine exposure, half-life, and other pharmacological parameters, which are used to guide decisions on how often and how much of a therapeutic should be given for efficacy without undue toxicity. 

	Bioanalytical assays extend beyond simply measuring drug concentrations over time but are also used to assess drug efficacy by way of pharmacodynamic (PD) endpoints (i.e., biomarkers). Biomarker assay results may provide early indicators of efficacy, or even safety issues. They can also be used to stratify patients to predict responders or non-responders.  Another key bioanalytical assay for biotherapeutics is the assessment of immunogenicity (both wanted and unwanted). For vaccine development, a positive immunogenicity result may be considered to be potential evidence that the vaccine is working as intended. Unwanted immunogenicity is much more complicated as the impact of anti-drug antibodies may influence the pharmacokinetics, efficacy, and safety, and has to be looked at down to the individual patient level.

 What type of data/information in particular do global regulatory authorities require from bioanalytical studies?

 For any regulated bioanalytical study to occur, a validated method is required. FDA has issued guidance documents detailing the scope of bioanalytical method validation required for PK/PD endpoints, but it is also important to consider other regional guidance documents (e.g., European Medicines Agency, Pharmaceuticals and Medical Devices Agency [Japan], Agência Nacional de Vigilância Sanitária [Anvisa] [Brazil], etc.) when conducting method validations. The general assessments for method validation consist of accuracy, precision, selectivity/specificity, linearity, robustness, and stability.  

	Depending on the type of assay, certain parameters may be added or removed to meet the assays’ context-of-use, and the analytical acceptance criteria may also vary. For immunogenicity assays, a statistical report or summary is required to justify your cut point(s). A well-described validation plan detailing the experiments and a priori acceptance criteria should be written and approved resulting in a bioanalytical report summarizing the experiments in tables, descriptions of deviations, and any pertinent conclusions. A quality statement from a quality assurance unit is typically included in the report for any regulated work. 

	Once the methods are validated, the sample analysis commences that follows bioanalytical plans and/or standard operating procedures (SOPS). The reported data typically contain information on subject (or animal) number, dose/treatment group, time point, and analytical result. A listing of assay performance characteristics, which include tables of assay control results, run summaries, and calibration curve results, are typically provided. Additional information, such as incurred sample reanalysis results and sample condition (e.g., hemolyzed) may also be included.

 On a broader perspective, FDA requires PK, toxicokinetic, or biomarker concentration evaluation through bioanalytical studies. It is critical that the data [are] generated via phase-appropriately validated methods (i.e., the methods are ‘fit-for-purpose’) and in many cases adhere to 

 58), Good Laboratory Practice for Nonclinical Laboratory Studies (1). These involve much experimentation, data curation and storage, quality review, personnel training, and generation of SOPs-all related documentation should be available for review by FDA, along with the bioanalytical report. 

	On a global scale, requirements and expectations around regulated bioanalysis generally follow the same thread as FDA, but with specific regional differences. Most jurisdictions have independent bioanalytical method validation guidance. 

 What types of approaches or strategies are best to plan out early on in the drug development process? 

 Bioanalytical studies are challenging to design and plan properly at the onset of the drug/biologic development process, as they involve samples from multiple pre-clinical species, tissue types, and human-derived samples with a diverse (and in most cases unknown) genetic and metabolic makeup. The bioanalytical methods need to be robust enough to work with the variability that comes with such a diverse set of samples. 

	It is thus important to anticipate these challenges early on while in the R&D phase, and develop sample preparation protocol(s) and method(s) that can work with such diverse types of samples, varying sample amounts, and be able to account for less-than-ideal sample handling during shipment and storage. It is also preferable to start the method validation process early that ensures that the data are reliable. While FDA guidance suggest that the level of validation should be appropriate for the intended purpose of the study, it is often helpful and cost-effective in the longer term to expand validation a bit beyond that so as to get better prepared for the later development process.  

 Early in clinical development, it is important to understand the context-of-use for your bioanalytical assays, what type of therapeutic you have, and how your clinical studies are going to evolve. For instance, if you think your lowest effective concentration of your therapeutic is 500 µg/mL (trough levels), then developing an immunogenicity assay that is tolerant to high levels of therapeutic would be a critical consideration early in development. Whether or not your Phase I study is going to be in patients or healthy volunteers is another important consideration. 

	Similarly, the disease-state biomarker assays may require different sensitivities than if it was in a normal population. Understanding the sensitivity requirements for your PK assay is also important. Intravenous administration of the therapeutic may require a less sensitive assay in your serum samples, whereas an ocular injection of the therapeutic will require a very sensitive serum PK assay to measure circulating drug levels. When conducting a preclinical toxicology study, the PK assay may not need a very low limit of quantitation since the therapeutic will be dosed at high(er) levels, and the immunogenicity assay may not have a confirmatory tier as an immune response is expected from a foreign protein. Perhaps you have a novel cell therapy, and a flow cytometer is used to collect ‘cellular kinetics’. This means special handling instructions to analyze the samples within the demonstrated stability window, or the use of additives in the collection tube to stabilize study samples.   

 Are there any ‘best practices’ procedures or steps you can recommend for beginning a bioanalytical study program for a new therapeutic?

 There are a few best practices to consider, including identifying an appropriate blank matrix pool, testing disease-state selectivity as early as possible, and having a good supply of excellent critical reagents identified and appropriately characterized. Addressing these considerations will go a long way to avoiding future analytical headaches. Understanding the mechanism of action of your drug and how it relates to the sample is a critical assessment. For instance, if the drug target is a soluble cytokine that is abundant in serum and plasma, don’t be surprised if your selectivity experiment fails. More importantly in that case, what matrix pool are you using for your standard curve? Is the pool stripped of the cytokine, or did you use a surrogate matrix that doesn’t contain the interfering molecule?  

 FDA’s 2018 guidance on bioanalytical method validation (2) is a great place to start. Additionally, while still in draft form, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) M10 

 guidance (3) has been a decade-long collaborative initiative of analytical sciences and regulatory agencies around the globe; it is among the best resource currently available to plan for, and design bioanalytical studies.

 Why is it important, or even necessary, for some biopharma companies to partner with an outsourcing partner for the purpose of bioanalytic studies?

 Method development in bioanalytical studies is a black box to many, requiring intense training and somewhat intuitive understanding of how analytes behave in diverse biological matrices. It is important to note that, unlike standard analytical studies, bioanalyses involve highly complex and largely undefined biological matrices, with likely millions of compounds that can interfere with specific and accurate concentration evaluation. 

	The required knowledge and expertise to successfully navigate bioanalytical studies may not be acquired quickly in-house, particularly when the regulatory landscape around bioanalyses changes regularly. Additionally, most bioanalytical studies are moving towards mass spectrometry (MS)-based analyses, which involve instrumentation that is too expensive to acquire for many companies and require specialized training for use and data analyses. 

	Furthermore, most bioanalytical studies involve conducting the work under good laboratory practice (GLP), thus, the analytical laboratory must adhere to 21 

 58. This requires companies having a quality system in place, regular audit of the facility, maintaining documentation, training records, instrument qualification, and so on, all of which often becomes too cumbersome for many biopharma companies with limited operational budget. It is thus much simpler to partner with a CRO with expertise in bioanalyses, which already have an established quality system and the required experience in interaction and data presentation to FDA and other regulatory bodies.  

 Partnering with contract laboratories can be extremely beneficial, and there are a number of reasons for doing so. The capacity in your own lab may have been exceeded and the need to outsource work to a partner lab would be necessary. Your own lab may be lacking in certain analytical equipment or experience, and a contract lab would be able to provide that service and expertise. CROs are particularly useful to smaller biotechs as the CROs can provide valuable consulting services and an expanded scope of service offerings such that they can be a ‘one-stop-shop’ for all of your bioanalytical needs. CROs have a very deep understanding of bioanalysis based on the number and diversity of assays they have developed. This is reflected in their scientific expertise as well as their understanding of global regulatory practices, since they are more frequently audited by multiple regulatory agencies; these factors end up benefiting all of their clients.

 (Government Printing Office, Washington, DC). 
	2. FDA, 

Bioanalytical Method Validation Guidance for Industry


	Vol. 44, No. 6
	June 2020
	Pages: 54–58

	When referring to this article, please cite it as F. Mirasol, “The Importance of Partnering for Bioanalytical Studies,” 

Bioanalytical studies are a significant part of biologic drug development that may require partnering with bioanalysis experts.

Partnering for Bioanalytical Studies

	Shimadzu has released the LCMS-8060NX triple quadrupole mass spectrometer, which offers enhanced method development and routine analysis. A combination of high sensitivity and high detection speeds further improves ease-of-use and robustness. The system offers greater operating efficiency to pharmaceutical companies needing to shorten drug discovery periods or reduce costs, clinical firms that handle complex biological samples, and entities in food science involved in investigating residual pesticides, among others, the company announced in a June 9, 2020 press release.

	In general, liquid chromatography–mass spectrometry (LC–MS) solutions provide the high selectivity, reliability, productivity, and sensitivity required in many industries. In particular, the new LCMS-8060NX enhances all these features and further strengthens Shimadzu's triple-quadrupole MS capabilities:

		World-class sensitivity and detection speed: the LCMS-8060NX offers among the highest sensitivity and detection speeds in the world, according to Shimadzu, and includes internal mechanical improvements to promote sample ionization. This enables high-sensitivity analysis even for compounds that are difficult to ionize.

		High robustness minimizes downtime: the newly introduced IonFocus unit reduces instrument contamination by guiding ions to the interior more efficiently and removing unwanted components, which helps to prevent decreases in detection accuracy or sensitivity. In addition, more robust components are used in ion-focusing, enabling more reliable analysis. The LCMS-8060NX therefore offers both higher sensitivity analysis and lower downtime.

		Greater ease-of-use for greater workflow efficiency: the system includes several “Analytical Intelligence” functions to maximize analysis throughput and improve the operational efficiency and productivity of the entire workflow, from preparations for analysis through to data processing. For example, it includes a new ionization unit that is capable of high-sensitivity analysis without the need for complicated adjustments and enables more efficient method development, as well as functions to start up or shut down analytical instruments automatically in combination with a Shimadzu Nexera LC system.

		Flexibility of a common platform: Shimadzu’s LC–MS range from single to triple quadrupole systems enables more compounds to be screened in less runs while increasing sensitivity and data quality. Many accessories, software, data banks, and method packages complement the systems. Depending on the need for sensitivity in the lab, one model always fits, bringing robustness while keeping the flexibility to upgrade at a later stage as soon as requirements change.

Enhanced sensitivity and ultra-high detection speed provide improved robustness and operability.

Shimadzu’s New LCMS-8060NX Mass Spectrometer Offers Enhanced Performance

	Pall Laboratory, a provider of filtration, separation, and sample preparation solutions, has introduced two new AcroPrep 24-well filter plates: one is the AcroPrep 24-well cell clarification and sterile filtration plate, and the other is the AcroPrep 24-well 0.2 µm sterile filtration plate.

	The AcroPrep 24-well filter plate for cell clarification and sterile filtration can be applied to Chinese hamster ovary (CHO), human embryonic kidney (HEK), or other cultured cells in one step, in a single device, in minutes. This new filter plate is ideal for laboratories that require faster and more efficient protein purification workflows, the company said in a June 16, 2020 press release.

	"Pall's AcroPrep cell clarification and sterile filtration plate saves considerable time, reduces consumable waste, and streamlines laboratory processes compared to the conventional two-step cell clarification and sterilization process," said Lori Euler, Pall's product manager, Molecular, in the press release. "It enables researchers to more quickly and easily sterile filter proteins from high-density cell cultures-speeding up cell-line development and clone screening."

	By combining both clarification and sterilization steps, the plate eliminates the need to harvest the cells in an offline centrifugation step, saving time. The filter plate's innovative one-step workflow uses multi-layer filtration media and membranes integrated into one device. The top layer features Pall's Seitz depth media that efficiently captures whole cells and cell debris. A 0.2-μm Supor EKV membrane provides an efficient sterile filtration layer. This combination effortlessly recovers more than 95% of extracellular proteins from whole cell cultures of up to 25 million (or more) cells/mL of varying viabilities.

	Additionally, this device can substantially reduce plastic consumable use, Pall stated in its press release. In one example, it reduced plastic use by mass of seven times versus a conventional two-step process, significantly reducing disposal costs and environmental burden.

	The second product, the AcroPrep 24-well 0.2 µm sterile filtration plate can be used in applications where a sterile filtrate is required. The device is designed for high-volume (up to 7 mL) processing of media, reagents, serum, or proteins. The 24-well Supor EKV plate features a dual-layer configuration-a 0.65-μm membrane integrated with a highly asymmetric 0.2-μm membrane-for fast, efficient, and sterilizing-grade filtration. The gamma-irradiated device demonstrates retention of a minimum of 107 cfu/cm

 of Brevundimonas diminuta per modified ASTM F838 guidelines.

	Both products can be used with either a vacuum manifold or compatible centrifuge and are fully compatible with all major laboratory automation platforms.  Each filter plate comes individually bagged with a collection plate and lid. The devices are well suited for clone selection and clone candidate analysis, cell expansion studies, recombinant protein isolation prior to analysis, cell clarification, process optimization, and general sterile filtration.

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Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

Pall’s 24-Well Filter Plate Performs Cell Clarification and Sterilization

	Avacta Group, the developer of Affimer biotherapeutics and reagents, has provided updates on its COVID-19 antigen diagnostic tests that it is developing with Adeptrix and Cytiva, respectively. With Adeptrix, a provider of analytical platforms based on bead-assisted mass spectrometry (BAMS), Avacta is developing a BAMS diagnostic test for COVID-19 infection. With Cytiva (formerly GE Healthcare Life Sciences), Avacta has developed Affimer-based rapid test strips to detect SARS-COV-2 spike protein.

	The BAMS diagnostic test has reached prototype stage, Avacta announced in a June 9, 2020 press release. The assay uses Affimer reagents specific to the SARS-COV-2 virus recently developed by Avacta to capture the virus spike protein from the sample. The method breaks up the spike protein captured from the samples and is able to identify fragments of the spike protein using mass spectrometry at concentrations in the range found in patient samples generated from standard throat swabs.

	The combination of the selectivity of the Affimer reagents with the precision and accuracy of mass spectrometry detection provides a high degree of specificity in the assay, Avacta stated in the press release.
	
	The next step in the development of the final product is to evaluate and optimize the assay using patient samples at laboratory sites in the United Kingdom and United States, which will be done imminently before moving to manufacturing, clinical validation to quantify the sensitivity and specificity, and CE/FDA approval for professional use in the summer of 2020. The final product will be able to run on the installed base of mass spectrometers in clinical laboratories worldwide, according to Avacta.
	
	“I am very pleased with the rapid progress made by our partners at Adeptrix and delighted that the Affimer reagents that we have developed to detect the SARS-COV-2 spike protein are working very well in the BAMS assay.  This bodes well for all our COVID-19 antigen test development programs,” said Dr. Alastair Smith, CEO of Avacta Group, in the press release.

	“A COVID-19 BAMS assay could provide highly sensitive and specific testing for up to a thousand samples per day in the hospital setting using standard equipment that is available but not currently used for coronavirus testing thus contributing significantly to an increase in global testing capacity,” Smith added.

	Meanwhile, the Affimer-based rapid test strips developed with Cytiva show positive initial performance data, Avacta announced in a June 24, 2020 press release. In mid-May 2020, Avacta provided Affimer reagents that are specific to the SARS-COV-2 spike protein to Cytiva, which then developed the first lateral flow test strips using these reagents and generated initial performance data using coronavirus spike protein, Avacta reported in the press release.
	
	The data show that the test strips detect the spike protein in model samples at concentrations within the clinical range found in saliva of patients with COVID-19. Work continues to refine the test strip design, optimize its performance, and get the best detection limit possible to generate significantly high sensitivity in the final rapid test product.
	
	Following the optimization of the lateral flow test by Cytiva, the design will then be transferred to manufacturing partners in the UK that are currently being put in place by Avacta. The company is working with these manufacturers to compress the normal manufacturing, clinical validation, and regulatory timelines to bring a product to market as quickly as possible, the company stated in its press release.
	
	“I am delighted with the progress made by our partners at Cytiva and very encouraged by the positive data from the first test devices. We now need to optimize the test performance to achieve the best possible limit of detection as this will ultimately play a significant factor in determining the clinical sensitivity of the test,” said Smith in the press release. “This is a really positive step and we aim to have completed the optimization very soon so that we can begin the transfer to manufacturers. I will be updating the market on progress in due course.”
	
	“I am pleased that the test development has progressed from a working initial design to now focusing on optimizing the test as much as possible. The Affimer reagents have worked well in lateral flow test strips and we are very encouraged by the initial data,” added Klaus Hochleitner, global lead, Technology Product Specialist, Cytiva, in the press release.

The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.

Avacta Provides Updates on COVID-19 Antigen Diagnostic Test Development

	Thermo Fisher Scientific announced its NanoDrop One PC Control + Security Suite Software for the NanoDrop One/One

, an instrument that identifies contaminants in nucleic acid and protein samples, can now be used in compliance with FDA’s Title 21 

 Part 11, which covers the security of electronic records and signatures to guarantee they are reliable alternatives for paper records and handwritten signatures.

	According to a June 8, 2020 press release, the security suite met FDA’s requirements because of its ability to provide administrative control over user accounts, utilize an audit trail for user integrity, and use electronic signatures.

	"Regulated pharma and biotech labs can now take full advantage of our powerful NanoDrop One/One

 instruments," said Jim Metzger, general manager, UV/Vis spectroscopy at Thermo Fisher Scientific, in the press release. "NanoDrop One/One

 is the market-leading microvolume spectrophotometer for DNA, RNA, and protein quantification, and we're pleased to extend these critical instruments to labs where compliance is a requirement."

Its NanoDrop One PC Control + Security Suite Software for the NanoDrop One/OneC can now be used in compliance with FDA regulations.

Pharmaceutical Technology's In the Lab eNewsletter-07-01-2020