Bioassays play a crucial role in biologic drug development as a means to determine potency, toxicity effects, pharmacological activity, stability, purity, and other product qualities. The complexity of biological molecules, however, requires a wide range of analytical procedures to adequately characterize the product. In particular, the concern over immunogenicity in the use of biologics is driving the need to develop more highly sensitive assays. Because of this concern, there is a continual need to refine biological assays to increase accuracy and reproducibility. There is a specific need to replace 

 bioassays are important tools employed during drug discovery/drug development, according to Weihong Wang, PhD, director of Technology Development, Eurofins BioPharma Product Testing. 

 bioassays use cell culture and offer the benefit of low cost and high throughput, both of which are essential during early development. An 

 bioassay also has the necessary robustness needed for use as a lot-release assay for product quality control later in the drug development life cycle, Wang explains.

 bioassay is a more efficient method that allows researchers to clearly characterize product mechanism of action in a controlled environment, says Catherine Liloia, director, Cell & Microbiology, PPD clinical research, Thermo Fisher Scientific. “This approach is scalable and reproducible across production and can assess product stability,” she states.

 bioassays (non-clinical) use animal models and are considered more relevant to potential clinical outcome, says Wang. 

 bioassays are often costly, however, and are less robust and subjected to strict regulations and compliance standards. “Regulatory agencies across the world have been encouraging sponsors to replace, reduce, and refine (the three Rs) dependence on animal studies by advancing development of, and evaluating new, fit-for-purpose methodologies,” Wang explains.

 bioassays are more representative of the full biological complexity and pharmacokinetics of the human body; they can, therefore, more broadly assess potential patient safety impacts stemming from metabolic changes and other side effects. The downside, however, is that 

 bioassays require high investment, strict animal care protocols, and are not as conducive to high-level analytics, according to Liloia.

, generate valuable data needed for regulatory filings, such as investigational new drug (IND) applications. 

 bioassays support determination of product potency, for instance, says Liloia. “When included in analytical panels during release and stability testing, potency data can demonstrate lot-to-lot consistency and long-term stability of the product,” she says.

In addition, bioassays provide data to better understand the impact of manufacturing process changes through process development. “Early 

 methods may be needed to help discern true product mechanism of action in biological pathways that are complex or not well characterized. These methods can sometimes be consolidated or replaced on a product release panel as data [are] collected to determine a single method’s capability to reliably determine product potency across production samples,” Liloia explains.

 method cannot by itself model the biological response in a reliable manner, as is the case with immunogenicity and other safety testing, Liloia adds.

IND-enabling studies, including pharmacology/pharmacodynamic, pharmacokinetics, and toxicology studies, are typically done through both 

 assays, states Wang. She adds that additional 

 assays to address product safety and quality, such as viral testing, and potency testing, are also necessary later on for product licensing.

Cell-based bioassays have also become an important tool in the analytics arsenal for biologics drug development. According to Wang, cell-based bioassays measure relevant physiological responses in cell cultures, but unlike 

 bioassays, cell-based bioassays do not involve the use of live animals and often have different types of assay readouts/endpoints. “Nevertheless, the physiological responses are reflective of mechanism of action, and, therefore, cell-based assays are considered necessary components of product characterization, in addition to other biophysical/physiochemical analytical methods,” she states.

Cell-based bioassays utilize biologically relevant cell lines to measure product potency, says Benjamin Ziehr, senior group leader, PPD clinical research, Thermo Fisher Scientific. He notes that there are several types of cell-based bioassays that vary depending on what is being measured. “The classic cell-based bioassay compares the response of cells treated with drug sample or reference standard. Typically, sample and standard are diluted in a manner suitable to produce a four-parameter response curve in the target cell line. Well-defined response curves are critical for maintaining and demonstrating control of the assay and drug product in these assays,” he explains.

Ziehr further explains that the relative activity of sample drug material to reference standard drug material is reported as the relative potency of the drug product. In comparing cell-based bioassays to other types of bioassays, the key distinction lays in the fact that cell-based bioassays allow mechanism-of-action-dependent measurements, whereas other bioassays measure physical characteristics of the drug product, such as epitope binding or receptor occupancy. “Therefore, cell-based bioassays allow measurement of the cellular processes responsible for a drug product’s effects on the patient,” says Ziehr.

Meanwhile, there are several other modes of cell-based bioassays that provide information about other attributes of the drug product. Ziehr points out two common examples of these other modes from cell and gene therapy product testing: infectivity and replication competency assays. “These assays measure the infectious potential of the drug product and the presence of replication-competent viral particles, respectively,” he states.

In other words, rather than measuring a cellular response, these infectivity and replication competency assays measure the accumulation of viral genetic material following infection of permissive cell lines. “While these assays don’t measure product potency, they do provide critical process and safety data and detect lot-to-lot variability of products,” says Ziehr.

Cell-based bioassays become a clear front runner in this movement, where applicable, remarks Wang, who points out that, in other circumstances, sponsors may be able to eliminate certain 

 assays based on risk analysis. For example, per the International Council for Harmonisation Q5A(R2) (2), 

 testing is no longer necessary for well-characterized cell lines such as Chinese hamster ovary, non-secreting murine myeloma, and SP2/0 (a standard mouse myeloma cell line), based on cell-line history, prior knowledge, and other risk-based considerations, notes Wang.

Despite their advantages, however, cell-based bioassays are limited in their ability to represent more complex, distal biological responses in a patient, cautions Liloia.

Meanwhile, the challenges in working with cell-based bioassays include not only the fickleness of working with certain cell lines, but also the fact that the day-to-day variability is much higher in terms of assay performance, observes Ziehr. The state in which cells enter the bioassay affects their response in the bioassay.

“Cellular state is dictated by many factors, notably metabolic stimuli, cellular density—both in culture leading up to a bioassay and in the bioassay itself—and cellular age. Stable transfections, optimized banking, and robust maintenance controls are needed to minimize cell variability,” Ziehr says.

Ziehr explains that, typically, robust maintenance controls involve the use of well-defined and controlled culture protocols, qualification of critical reagents, and substantial system suitability criteria in the bioassay. “Consistency of technique is challenging, even with clear procedure, so robust training with clear connection between biological processes and cell handling technique remains important,” he remarks.

Because cell-based assays utilize live cells, they are subjected to intrinsic assay variability that are often larger than that of physiochemical methods, says Wang. Thus, the selection of an appropriate cell line that is not only relevant to product mechanism of action, but also able to support a robust response in a dose dependent manner, is the single most critical factor for successful method development, she emphasizes.

“Many details need to be considered and optimized to produce a robust assay suitable for quality control. In addition, for products that may have multiple mechanisms of action, a carefully selected matrix containing multiple cell-based assays may be necessary to fully characterize the product,” Wang says.

Wang also points out, however, that it may yet be difficult to develop a cell-based bioassay for some products that either have not known defined mechanisms of action or have complex mechanisms of action. Furthermore, some cell-based assays still require extended testing time, which can be a cause for concern regarding products that require rapid factory-to-patient delivery. In such cases, Wang suggests that development of surrogate assays and/or orthogonal assays may be beneficial, though subject to discussions with the relevant regulatory agency.

In terms of advantages conferred, compared to 

 bioassays, cell-based bioassays often offer the advantages of a more streamlined testing procedure, higher assay throughput, quicker turnaround time, and less assay variability, according to Wang. “It is generally easier to develop a cell-based assay with an accurate quantitative endpoint than an 

 assay, which is particularly essential when the method is intended to be used for quality control,” she states.

Liloia notes that cell-based methods are quite challenging in many areas. Solutions such as liquid handling automation helps in providing accurate and precise sample dilution pipetting and transfers to the low concentrations and small volumes often needed in a cell-based assay. She also notes, however, that analytical workflows have become more complex because of the diversity of analytical readouts needed to support expanding product areas.

The growing complexity of analytical workflows has resulted in a greater need for coordination across functional areas, broadened cross-training, and design changes to laboratory spaces to maintain efficiency while also maintaining process flows that consider biosafety and contamination prevention, Liloia says. “Data analysis expectations continue to evolve as laboratories and agencies gain experience with newer products, requiring strong statistical support and the ability to apply industry best practices in a new way,” she states.

Overall, cell-based bioassays are considered a critical tool to predict quality and safety of drug products in the patient. “When established early in the development process, cell-based bioassays can provide early indicators of lot-to-lot variability in manufacturing, drug potency stability, and impact from process changes,” states Ziehr.

“Bioassays have an essential role throughout the life cycle of product development of biologics.Many aspects of product discovery, development, characterization, and quality control require careful construction and implementation of bioassays in order to thoroughly assess product safety, efficacy, and stability,” Wang adds.

1. Mire-Sluis, A.R. Progress in the Use of Biological Assays During the Development of Biotechnology Products. 

, 18, 1239–1246. DOI: 10.1023/A:1013067424248.
2. ICH, Q5A(R2) 

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Feliza Mirasol is the science editor for 

Articles

Features

As the development of increasingly complex biologics grows, more robust bioassays are required to accurately characterize these molecules.

Robust Bioassays Needed for Increasingly Complex Analytical Workflows

Within the bio/pharma industry, there is a certain expectation for companies to maintain required levels of cleanliness within their facilities to ensure products that are manufactured are at minimal risk of contamination. All cleaning processes must also be validated for effectiveness and reproducibility.

As drug products become more complex and sensitive to potential contaminants, there is an increasing demand for cleaning validation throughout industry. According to market research, the cleaning validation market is forecasted to grow by a compound annual growth rate of 5.7% between 2021 and 2027 (1).

Of course, the requirement for manufacturing equipment to be clean is nothing new; as Andrew Kolbert, PhD, senior leader, Technical Solutions, Element, points out, this facet of drug production has been a necessity for 70 years since the introduction of the 21 Code of Federal Regulations (CFR) 210 Part 133.4 (2). “Early efforts [in this field] were focused on avoiding microbiological contamination or just filth, as seen at food manufacturers,” he states.

“In 1978, the GMPs [good manufacturing practices] were amended to 21 CFR Part 210.67, which specifically addressed the issue of cross contamination, as opposed to mere unsanitary conditions, with particular focus on manufacturers that made penicillin and other pharmaceutical products on the same equipment train,” Kolbert continues. The issue of cross contamination was brought to the fore by a case in 1988, he highlights, where a drug product, Cholestyramine Resin, was recalled due to contamination with pesticides as a result of insufficient cleaning of solvent drums (3).

“Cleaning validation is a subject that receives a great deal of attention within biopharmaceuticals, not least due to the risks presented in terms of product adulteration from cross-contamination and, hence, patient harm from improperly cleaned surfaces (and noting additional concerns such as operator protection),” specifies Tim Sandle, head of microbiology at Bio Products Laboratory (BPL) in Elstree, UK.

Sandle also highlights microbial proliferation as an area of importance because of the risk it poses in terms of the numbers of organisms adhering to surfaces and the release of microbial toxins. “Under the least desired conditions, a combination of organic residues and the presence of microorganisms can lead to a biofilm developing,” he says. “Biofilms are difficult to detect, and they are challenging to remove.”

Therefore, it is expected, by the regulatory bodies, such as FDA, that a drug manufacturer has a cleaning process in place for all equipment to ensure that no drug residue exceeds the maximum allowable carryover (MACO) level—a level that is determined based on toxicological risk—and that there are no cleaning agent residues and so forth, Kolbert asserts. “The cleaning process must also be validated to ensure it is consistently reproducible and effective. The exact form of this validation depends on the nature of the equipment as well as the cleaning process,” he says. “If cleaning is to be done manually, the reproducibility across workers will be need to be explored. If solvents or detergents are used, reduction to an acceptable level must be demonstrated.”

“Approaching cleaning validation should always begin with a risk assessment,” emphasizes Sandle. “To be effective, the risk assessment needs to be built upon a thorough understanding of the equipment to be cleaned and the cleaning reagents and mechanisms.”

Additionally, any residue(s) that needs to be removed must be identified and the optimal method to remove the residue(s) must be considered, Sandle continues. “For example, some residues are best cleaned by either an alkaline or acidic cleaner (or both types of cleaning agent may be required). To ensure the designed process has a greater chance of being effective, it is also important to understand how the residue is actually being removed (which requires detail of the residue chemistry),” he states.

“The next step is whether to use product residues or an alternative soil to challenge the designed cleaning process,” Sandle adds. “Users need to assess whether product residues are suitable for the cleaning validation because some process soils pose little challenge to the cleaning system, and it may be more appropriate to use a surrogate with greater viscosity and binding characteristics.”

Furthermore, Sandle points out that consideration should be made to how much residue may be permitted to be left, which will impact the level of cleaning that is required. “This [consideration] means selecting appropriate sampling methods, typically based on rinsing and swabbing, and the appropriate test methods for microbial and chemical analysis,” he says. “With methods, there needs to be an understanding about the metrology of the test instruments and the likelihood they can quantify the minimum acceptable residue. In addition to typical analytical method validation parameters (specificity, accuracy, linearity, limit of detection, precision), the actual sampling procedure must be qualified.”

For Kolbert, swabbing all of the drug product contact surfaces along the manufacturing train using the simplest analytical finish that will achieve an appropriate limit of detection is the most common approach. “If the drug product has a chromaphore, HPLC [high-performance liquid chromatography] or even UV [ultraviolet]/vis [visible] may be sufficient,” he says. “It is important to detect not only the drug product but any degradants or by-products that may be created.”

Also, if a detergent mix or solvent is required for the cleaning process then merely analyzing the rinsate does not suffice, Kolbert admonishes. “The product path components must also be tested for residue by direct swabbing,” he states. “A commonly used metaphor is if you are cooking in a pot, it is not enough to analyze the water rinse, you also need to look at the pot for old product residue that may break off over time.”

Increasingly, companies are utilizing highly potent drugs in biopharmaceuticals, which is creating challenges in terms of cleaning validation, asserts Kolbert. These drugs have extremely low MACO, which has driven analytical limits of detection to barely achievable levels, he adds. As a result, it is becoming necessary to use liquid chromatography coupled with tandem mass spectrometry to hit the toxicologically driven thresholds, Kolbert states.

In Sandle’s opinion, the main challenges in cleaning validation are in relation to residue removal, which is partially dependent upon the required level of cleanliness and the level of cleanliness that can actually be achieved—which relates to the design of the equipment. “Ideally, equipment selection will have embraced quality-by-design and there will be no inaccessible parts,” he continues. “However, in reality, some areas of large items of equipment are easier to clean than others and the main challenges that arise are often cantered on developing cycles that can reach challenging locations [such as] narrow pipes, u-bends, valves, and so on.”

Another area that is sometimes neglected is consideration of the age of equipment, Sandle specifies. “Manufacturing activities have the potential to induce abrasion and corrosion,” he says. “Hence, consideration must be given to ageing equipment with any aspect of cleaning.”

Regulators expect companies to conduct a risk assessment, Sandle points out. “With the risk process, it is good practice to use a multi-disciplinary team. The team should assess indirect product contact pars in relation to: the ability to build-up residues and the ability to transfer residues to product contact sites,” he explains.

Additionally, there is an expectation from regulators that all sample locations selected are represented and that potential ‘worst cases’ are indicated, Sandle notes. “I have seen several regulatory findings for cleaning validation that has been undertaken using locations that are not sufficiently challenging,” he says.

“A common regulatory issue also relates to manual cleaning,” Sandle continues, “especially around verification [as to whether] the operators can continue to undertake manual cleaning to a reliably high standard.”

Essentially, the cleaning process needs to be documented and demonstrated to be valid as per the regulatory bodies’ guidance, such as FDA outlined in Validation of Cleaning Processes (7/93) (3), confirms Kolbert. “There are a number of pitfalls that must be avoided, such as an overreliance on rinse analyses instead of direct observation of the equipment product contact paths; lack of sufficient evidence of reproducibility of any manual steps in the cleaning process; and verification of the absence of cleaning agents at the conclusion of cleaning,” he emphasizes.

“Perhaps the most important lesson from regulatory findings is the importance of running a risk assessment to manage the process, focusing on the proactive identification of hazards, selecting the optimal process to reduce the risk presented by these hazards, and with that ensuring there is a suitable measure of detection in place to verify the outcome,” Sandle says.

Sandle hopes that there will be increased use of rapid methods in cleaning validation that can provide real-time assessments in the near future. 

“Adenosine triphosphate (ATP), protein residue, and glucose residue swabs are among the more useful rapid methods, although further development is required to improve accuracy and repeatability,” he highlights. “Of the different ‘PAT [Process Analytical Technologies] methods’, ATP bioluminescence technology offers a higher sensitivity compared with colorimetric methods.”

In terms of management of cleaning validation processes, software developments are piquing Sandle’s interest, including some that are employing artificial intelligence. “Such packages can help to sort equipment into types where a matrix approach is preferred, as well as enabling scheduling and for setting re-validation targets,” he states.

At its very essence, cleaning validation will require greater consideration, simply as a result of the evolving therapeutic landscape, Kolbert asserts. “The increased use of biological therapeutic agents in pharmaceutical manufacturing will require increased complexity of analytical techniques as activity of the residue is as important as chemical presence,” he summarizes.

1. MMR. Pharmaceutical Cleaning Validation Market: Industry Analysis and Forecast (2021–2027) by Product Type, Validation Test, and Region. Report,.October 2021.
2. CFR Title 21, 210 Part 133.4 (Government Printing Office, Washington, DC).
3. FDA. Validation of Cleaning Processes (7/93), Inspection Guide. Aug. 26, 2014.

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

Analytical techniques for validating cleaning methods must evolve to match the pace of an increasingly complex manufacturing landscape for new therapeutics.

Validating Cleaning Methods in Bio/Pharma Processes

Thermo Fisher Scientific and AstraZeneca announced a collaboration to develop a solid tissue and blood-based companion diagnostic (CDx) test for osimertinib (brand name Tagrisso) on Jan. 24, 2023. The CDx is intended to help identify patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with osimertinib by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations, including exon 21 L858R mutations, exon 19 deletions, or T790M mutations.

According to a company press release, the test will use the Oncomine Dx Express Test on the Genexus Dx System, a fully integrated next-generation sequencing platform. The platform features an automated specimen-to-report workflow and can deliver results after 24 hours.

“As part of our ongoing partnership with AstraZeneca, today’s announcement will help bring targeted oncology treatments to more patients in need of new care options,” said Garret Hampton, president of clinical next-generation sequencing and oncology, Thermo Fisher Scientific, in the press release. “By leveraging the Genexus Dx System’s unprecedented turnaround time, we can help ensure molecular testing results are more readily available to inform vital treatment decisions.”

News

AstraZeneca and Thermo Fisher will collaborate to develop a solid tissue and blood-based companion diagnostic test for osimertinib.

AstraZeneca and ThermoFisher to Collaborate on Companion Diagnostic Test

Be The Match BioTherapies, a provider of solutions for developing and commercializing cell and gene therapies, in conjunction with the Center for International Blood and Marrow Transplant Research (CIBMTR), is offering expanded clinical research organization (CRO) services. These services are designed to help companies reduce the time required to launch and execute clinical trials.

According to a Jan. 17, 2023 company press release, the new CRO Services provide turn-key solutions, including protocol development and approval oversight, project management, site selection, site start-up, data management, research sample/laboratory coordination, study monitoring, statistical analysis, patient-reported outcomes, and financial administration. Companies also have the option to only choose select services, including data analysis, surveys, site selection and management, and sample management.

The CRO services feature built-out clinical infrastructure, including a single institutional review board, a dedicated data safety monitoring board, master contracts, and 

 compliant software. Customers will also gain a direct link to the CIBMTR outcomes database, consisting of data from more than 575,000 patients.

“Be The Match BioTherapies and its partners have successfully supported bone marrow transplant and cellular therapy clinical trials for nearly 20 years,” said Erin Leckrone, senior director, Clinical Trials, CIBMTR, in the release. “Today, with our formal launch of CIBMTR CRO Services, the expertise and resources honed over decades of work by the leading experts are accessible to small-to-mid-sized biotechnology companies. These services, whether used in whole or as ad hoc support, will accelerate time-to-trial and bridge the transition from research to patients.”

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Be The Match BioTherapies Launches CRO Services for Cell and Gene Therapy

Scientific Laboratory Supplies (SLS), a supplier of laboratory equipment, materials, and supplies based in the United Kingdom, recently announced the acquisition of C&M Scientific, a scientific calibration, maintenance, and validation company also based in the UK.

According to a press release from Jan. 12, 2023, the acquisition aligns with SLS’ strategy of acquiring companies across the UK and Ireland. Operating throughout northern England and Scotland, C&M is fully accredited to ISO 9001, ISO 14001, ISO 45001, and ISO/IEC 17025 certification, and also adheres to Medicines and Healthcare products Regulatory Agency, FDA, and Good Manufacturing Practice standards.

“Our multidisciplinary service and product range combine to provide a complete solution for laboratories across Scotland and the North of England. Joining the SLS Group will help us further extend our reach and expand our product offering,” said Ian Alexander, managing director, C&M Scientific, in the release.

“We are thrilled to welcome C&M Scientific to the ever-growing SLS family,” said Ian Roulstone, managing director, SLS, in the release. “This deal represents another great addition to the SLS Group as C&M Scientific have cultivated a reputation for unrivaled technical expertise.

We are excited to further expand the SLS Group service provision and this acquisition continues our recent focus on developing a world-class service offering.”

Scientific Laboratory Supplies’ acquisition of C&M will bolster the company’s scientific calibration, maintenance, and validation offerings.

Scientific Laboratory Supplies Acquires C&M Scientific

Agilent and Quest Diagnostics entered into an agreement to expand access to the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test. The ctDx FIRST is a single-site premarket approved test that is approved by FDA (1) as a companion diagnostic (CDx) to identify advanced non-small lung cancer (NSCLC) patients who may benefit from treatment with adagrasib (brand name Krazati). Adagrasib is a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.

According to a Jan. 23, 2023 company press release, under the agreement, Quest will offer ctDx FIRST to healthcare providers in the United States seeking a minimally invasive liquid biopsy test option as a CDx for adagrasib. The test can be ordered online through Quest’s online connectivity platform, and healthcare providers may additionally direct patients to provide specimens at one of Quest’s 2100 patient service centers in the US.

“We are looking forward to the Quest Diagnostics alliance facilitating broad access to ctDx FIRST, our liquid biopsy solution,” said Paul Beresford, vice-president and general manager, Companion Diagnostics Division, Agilent, in the release. “This expands the testing options available for NSCLC patients as patients don’t always have tissue available for molecular analysis.”

"The addition of the ctDx FIRST test to our oncology menu underscores our commitment to providing access to precision medicine innovations to improve care for patients with cancer," said Kristie Dolan, vice-president and general manager, Oncology Franchise, Quest Diagnostics, in the release. "It also reflects our ability to optimize our national physician and patient access network to extend access to important medical innovations with the potential to improve patient outcomes."

1. FDA, “FDA Grants Accelerated Approval to Adagrasib for KRAS G12C-Mutated NSCLC,” Press Release, Dec. 12, 2022.

New Technology

Agilent will work with Quest Diagnostics to distribute the ctDx FIRST test.

Agilent and Quest Diagnostics to Collaborate on Lung Cancer Diagnostic

Illumina, a DNA sequencing and array-based technologies provider, and Nashville Biosciences, a subsidiary of Vanderbilt University Medical Center (VUMC), have teamed up with Amgen to provide whole-genome sequencing of approximately 35,000 DNA samples. The sequencing of this sample cohort, which primarily comprises DNA from African-Americans, is intended to mitigate their underrepresentation in research for clinical applications of genomics. The sequencing will be performed by deCODE genetics, a subsidiary of Amgen.

According to a press release from Jan. 9, 2023, the sequencing of these samples is the first step in Illumina and Nashville Biosciences Alliance for Genomic Discovery (AGD) program. The agreement intends to whole-genome sequence at least 250,000 de-identified human DNA samples from VUMC’s BioBU biobank over the course of two and a half years.

"The initial cohort will be among the largest sequencing efforts involving African Americans to date," said Leeland Ekstrom, CEO, Nashville Biosciences, in the release. "Once complete, this data set will provide a wealth of new information about the human genome and accelerate the study of disease in—and discovery of new therapeutics for—populations less well represented in prior large-scale sequencing efforts. The opportunity to sequence this diverse set of samples will help broaden our understanding for individuals who have been underrepresented in genetic research and continue to experience health disparities."

"deCODE's sophisticated human data capabilities are well positioned to sequence these samples and analyze the resulting data to provide a better scientific understanding of disease through the context of human diversity," said Kári Stefánsson, founder, deCODE genetics, in the release. "Insights from human data, including both genetics and clinical records, can help inform how medicines may affect different patient populations."

deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

Amgen, Illumina, and Nashville Biosciences Announce Genome Sequencing Agreement

Nova Biomedical, a life sciences instrument provider, recently announced the launch of the BioProfile FAST CDV, a high-throughput, fully automated viable cell density and viability analyzer. The device uses trypan blue dye exclusion methodology for determination of live and dead cells, as well a high-resolution camera/optics to provide cell density and cell viability measurements.

According to a press release from Jan. 3, 2023, the analyzer is capable of producing results in less than 70 seconds with 100 microliters of sample volume. It also performs all sample dilutions internally, which allows cell culture samples up to 140e⁶ c/mL to be analyzed without external sample dilution. The device can sample cell cultures via an external 36-position loans-and-go tray or via a 96-well plate option.

The software associated with the device has a built-in touch screen display and icon-based navigation. Its software and networking capabilities are 

 compliant and have also been designed to meet FDA’s new cybersecurity guidelines.

“We at Nova Biomedical are excited to launch the next addition to the BioProfile platform with the FAST CDV Analyzer,” said Matt McRae, Biotechnology Sales Product line manager, Nova, in the release. “The FAST CDV is a significant advance in automated cell density analyzers and breaks the boundaries of existing technologies. It will enable even faster evaluation of cell lines and physicochemical parameter optimization, ultimately bringing products to market faster.”

The BioProfile FAST CDV is a fully automated viable cell density and viability analyzer.

Nova Biomedical Launches Cell Density and Viability Analyzer

AbbVie and US-based Anima Biotech (Anima) have formed a collaboration to discover and develop messenger RNA (mRNA) biology modulators for three targets across oncology and immunology. In the collaboration, Anima will use its mRNA Lightning technology platform to discover novel mRNA biology modulators against the collaboration targets. The company will provide AbbVie exclusive rights to license and further develop and commercialize these programs, according to a Jan. 10, 2023 company press release.

Under the agreement, Anima receives $42 million in an upfront payment and may be eligible to receive up to $540 million in option fees and R&D milestones in the aggregate across the three targets. The company will also have the potential to receive further commercial milestones and tiered royalties on net sales. AbbVie has an option to expand the collaboration with up to three additional targets under the same terms as the initial collaboration, which may increase the potential value of the collaboration.

"This collaboration will give AbbVie access to Anima's leading technology platform and deep expertise in mRNA biology and will help further strengthen AbbVie's [capabilities] in discovering and developing drugs to make a difference in patient[s’] lives," said Jonathon Sedgwick, vice-president and global head of discovery research, AbbVie, in the press release. "Modulating mRNA biology with small molecules is a new approach and has the potential to address 'undruggable' targets with implications across multiple therapy areas."

"Anima's differentiated approach in the field of small-molecule mRNA drugs combines phenotypic screening with AI [artificial intelligence]-driven elucidation of the mechanisms of action. The power of our mRNA Lightning platform is validated by our multiple partnerships and a growing internal pipeline," said Yochi Slonim, co-founder and chief executive officer, Anima, in the release.

The collaboration between AbbVie and Anima Biotech will combine Anima's mRNA Lightning technology platform with AbbVie's extensive expertise in oncology and immunology.

AbbVie and Anima Biotech Partner on Discovery and Development of mRNA Biology Modulators

Getinge, a Swedish medical technology company, announced the launch of the LivitFlex bioprocess control system. The system is designed to help pharmaceuticals and biotechnology products reach market faster.

According to a Dec. 15, 2022 press release, the LivitFlex speeds up development through system flexibility, smart sensor technology, and easy-to-use software functionalities. Additionally, by accessing and controlling multiple controllers from a PC or tablet in a laboratory, users can set up parallel experiments and monitor all data from one central location.

“Combining the flexibility of the Livit Flex controller, the intuitive Livit software, and Getinge bioreactors enables acceleration of R&D processes to make sure that pharmaceuticals and biotech products will ultimately end up faster where they are most needed – with the patients,” said Matthijs Niemeijer, head, Product Management Bioreactor Systems, Getinge, in the release.

Getinge is launching Livit Flex, a bioprocess control system designed to help pharmaceutical and biotech products get to market faster.

Pharmaceutical Technology's In the Lab eNewsletter, February 2023