Lauren Lavelle

Biologics facilities have expanded and advanced within the past few months in terms of significant investments, construction on new facilities, and acquisitions of new locations. The following are a sampling of these advances. 

Pharmaceutical Technology's Biologics and Sterile Drug Manufacturing


eBook: Biologics and Sterile Drug Manufacturing, May 2021
May 2021
Pages: 60–62

When referring to this article, please cite it as L. Lavelle, “Biologics Facilities Expand and Establish New Locations in 2021,"

 Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook 

Articles

The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceutical space. 

Biologics Facilities Expand and Establish New  Locations in 2021

Determining cybersecurity risks as a result of the ongoing pandemic is necessary for pharmaceutical laboratories complying with lab data integrity practices. 

 spoke with Bob Voelkner, vice-president of Sales and Marketing at LabVantage Solutions; Matt Grulke, vice president of Research and Development, also at LabVantage Solutions; Dennis Curran, BIOVIA portfolio technical director at Dassault Systèmes; and Paul Smith, strategic compliance specialist, and Humera Khaja, software compliance program manager, both at Agilent Technologies, about the best practices for maintaining lab data integrity during the COVID-19 pandemic while combatting cybersecurity risks.

 What precautions need to be taken to protect lab data integrity and security during the pandemic?

 As organizations deploy enterprise lab information management systems (LIMS) in their laboratories to digitize their operations, data integrity features and capabilities are vital in ensuring compliance. Documenting and protecting data maintained in online systems during the pandemic is a key solution to keeping the lab working and its data safe.

 Organizations also need to continue to elevate the importance and visibility of cybersecurity. Many organizations will deploy a comprehensive cybersecurity program that includes routine training of staff on common techniques, ongoing patching of systems to address known vulnerabilities, and the continued use of tools and frameworks to prevent, detect, and minimize cyber threats.

 With many employees working remotely during the pandemic, biopharma organizations are under increased pressure to maintain the highest standards of data integrity, security, and quality. On the one hand, they are engaged in often multi-organizational, collaborative R&D initiatives to bring safe and efficacious therapeutics and vaccines to patients faster than ever. On the other hand, working remotely comes with many challenges related to accessing and sharing data securely. Increasingly, mobile teleworkers can inadvertently open the doors to bad actors who can access critical data and disrupt supply chains. As a result, organizations need to beef up their virtual private networks (VPNs) with robust system access logging. Who was in? When were they in and why? Were the activities approved, and by whom? Most importantly, organizations need to take precautions to ensure that project teams are sharing data securely. In this new, remote sharing ecosystem, is critical project data available to more people beyond just the involved project team?

 The pandemic resulted in all labs requiring the implementation of social distancing measures, as well as performing risk assessments associated with the potential impact and management of COVID-19 transmission within the lab. This constrained operations considerably, therefore, additional precautions were required to ensure that labs could continue, and to be compliant operationally with fewer lab personnel, and potentially reduced direct supervision.

Travel restrictions also limited external personnel such as service engineers from visiting labs to perform repairs, planned maintenance, and operational qualifications on analytical instruments. As a result, lab personnel may have had to perform these tasks while being remotely supervised, for example, via video link to the instrument manufacturer. With restricted service visits, it may have been necessary to utilize lab instruments outside of their scheduled maintenance or qualification tolerances, potentially impacting instrument performance and possibly data quality. Many non-essential lab staff, not able to enter their labs, were required to access lab systems remotely, which required closer attention to information technology (IT) infrastructure to ensure business continuity as well as data integrity.

Although all above mentioned actions were most likely supported by additional regulatory guidance and instructions related to the pandemic, labs may still have been exposed to unforeseen data integrity risks. To safeguard, it was essential that all deviations from standard working practices, and all controlled non-compliance with company policies, were well documented and subject to rigorous risk assessment to identify additional risks and implement additional safeguards to reduce the impact of these risks.

 Since FDA has reduced inspections, what are you seeing as the top areas of non-compliance regarding lab data integrity during the pandemic?

 To protect R&D data and avoid non-compliance with regulatory requirements during the pandemic, biopharma organizations need to pay close attention to lab procedures. Having procedures in place and following procedures can both be significant lab challenges in today’s new work environment. Organizations should assess standard operating procedures in the light of current working conditions to ensure that electronic reviews/approvals are properly structured and appropriate. This is especially important whenever paper-based organizations need to implement electronic workflows due to the pandemic. This can create a high-risk situation for regulatory violations by creating uncertainty around data.

In response to the pandemic and travel restrictions, regulators issued communications confirming the halting of on-site inspections. This initially applied only to overseas inspections but was then extended to domestic on-site inspections due to potential risks to inspectors. This triggered a move to remote and office-based inspections using secure video links. One positive to this approach has been closer pre-audit sharing of data and information prior to the virtual audit. One not so positive consequence of remote audits was reduced capacity of the auditor to apply critical thinking skills to what they found during the ‘walk-through’ of the labs. The pandemic also drove regulators to be more reliant on risk-assessments associated with a lab’s historical regulatory footprint to prioritize virtual audits.

FDA has been transparent in documenting cases of data integrity problems. When labs come to us, they either want to avoid compliance-encountering issues or need to remediate known problems. The pandemic has amplified this need as labs accelerate their digital transformation plans.

 What have been the greatest vulnerabilities that companies face regarding lab data integrity during the pandemic?

During the pandemic and ensuing lockdown, virtually all labs were forced to embrace remote working conditions. Vulnerabilities labs have faced during this time have been to the maintenance of data quality and data security, which are the essential subsets of data integrity. Organizations’ data governance programs have had to re-evaluate their IT security, data quality, and data management policies and procedures, to mitigate these vulnerabilities. Though regulatory audits were significantly reduced in 2020 due to the pandemic, regulators still expected that laboratories’ electronic data and computerized systems should remain compliant.

The pandemic also exposed that labs changed the way their employees accessed, viewed, and processed results, and other critical eRecords. Lack of trust in the results, or outputs of data analysis, could be of concern. If the data is to be considered trustworthy and of high-quality, it must adhere to the principles of data quality.

 Dealing with fully online and digital processes as compared to paper or spreadsheets requires the lab to adapt to commercial solutions and the rigor that compliance requires. Without a purpose-built LIMS solution that meets the current and future compliance needs of the regulated laboratory, labs face higher risk of non-compliance of data integrity guidelines.

 Increased electronic workflows and remote access during the pandemic gives malicious actors more opportunities to penetrate networks and compromise critical data, whether it is testing data for a batch of new vaccine or a Raw Material Certificate of Analysis documenting the material make-up of a product. With this in mind, biopharma organizations need to ensure that they are operating with robust VPNs and data backups. Biopharma organizations have already expanded their IT footprint to support home workers and hybrid workflows (e.g., lab staff onsite and supervisors, reviewers, and quality assurance [QA] offsite). They should continue to review their hardware, contingency plans, and any new, extended networks for vulnerabilities, especially if further shutdowns occur. In addition, organizations storing data in the cloud should ensure that their hosting company is following appropriate security protocols and that there is adequate redundancy built into the system. Finally, organizations should monitor their supply chains closely, as well as machines and equipment that generate data to ensure that the data is accurate and trustworthy.

Lauren Lavelle is the assistant editor for 

When referring to this article, please cite it as L. Lavelle, “Pandemic Spurs Cybersecurity Risks in Laboratories,” 

Pharmaceutical laboratories must work to maintain lab data integrity practices as the pandemic surges on and cybersecurity risks increase. 


Pandemic Spurs Cybersecurity Risks  in Laboratories 

As labs continue to advance and expand, many are choosing to divert from the many valves and pumps that come with traditional lab equipment and are instead opting for more compact, space-saving lab equipment and systems. The following are a sampling of these devices.

The Spectrum Compact CE System from Promega is a benchtop capillary electrophoresis (CE) instrument that allows users to perform sequencing and fragment analysis at the bench in laboratories of all sizes (1). It features run scheduling, an easy-to-use interface, convenient benchtop size, separate plug-and-play consumables, and on-site installation and operational training.

Additionally, the system supports microsatellite instability analysis, mixed sample analysis, forensic short tandem repeat analysis, and cell line authentication while processing up to 32 samples in a single run. Users can access the instrument via an integrated touchscreen or through added software that provides access to any computer on the same network. Guided software can also enable capillary electrophoresis capabilities to users regardless of skill level.

“The Spectrum Compact CE is personal and that’s one of the huge advantages that scientists will see with this instrument,” said Promega’s head of research, Doug Storts in a company press release. “An individual can walk into the laboratory and with minimal training, be able to change all the consumables, select which chemistries they want to use for both DNA sequencing as well as for fragment analysis, and perform the experiment. Literally everybody has access. It democratizes the use of the instrument in the laboratory.”

Thermo Fisher Scientific’s Tundra Cryo Transmission Electron Microscope (Cryo-TEM) uses artificial intelligence (AI), guided automation, and loader technology to simplify the overall usage of the microscope for researchers of any experience level (2).

The compact device features a cryo-loading station for sample loading and transfer to the microscope for assessment and structure determination, resolutions of 3.5 angstrom, and throughput within 24 to 72 hours.

"Cryo-EM is speeding the path to disease understanding and treatment. However, many institutions find these instruments to be out of reach because of cost and because they are too complex for new researchers," said Trisha Rice, vice-president and general manager of life sciences at Thermo Fisher Scientific, in a press release. "We worked with cryo-EM luminaries to develop an instrument that not only delivers results, but, more importantly, brings cryo-EM to more users."

Computrac Vapor Pro XL Autosampler from AMETEK Brookfield, part of AMETEK's Instrumentation and Specialty Controls Division, aims to increase the efficiency of the Vapor Pro’s moisture-specific analysis technology by analyzing up to 16 samples automatically with individual test profiles (3).

The compact device is suited for applications that require test automation and increased throughput and provides a chemical-free substitute for Karl Fischer titration. Additionally, it provides testing for applications in the pharmaceuticals industry as well as in other industries (food, lubricants, paints and coatings, plastics, and batteries).

"Busy quality managers will enjoy peace-of-mind and boosted productivity with an automated moisture analysis of up to 16 product samples," said Kai Johnstad, AMETEK Brookfield's global product manager, in a company press release. "Product stakeholders will also benefit from time and cost savings by ensuring the perfect moisture content without using Karl Fischer titration."

Enzo Biochem launched a portable microplate reader for users looking to perform simplified lab work outside of traditional research facilities (4). The instrument, which is one-tenth the size of the average benchtop plate reader, can be used in conjunction with Enzo’s enzyme-linked immunosorbent assay and assay kits to deliver results regarding metabolites, hormones, proteins, and protein characterization.

The MiniSlide MSA series is a compact linear actuator that is highly configurable and easy to integrate (5). Available in a 2-mm, size 8 and a 20-mm, size? [as in “size 19000”?] 19000 with nine different lead screw options ranging from ~0.3 mm to 8 mm, the series is best suited for sample handling, spectrometers and chromatographers, molecular analyzers, optical microscopes, and other inspection equipment. Additionally, the series provides resolution down to 0.001524 mm (0.00006 inches) per step, axial forces up to 45 N, stroke lengths of up to 150 mm, and four different lubrication options, a rotary encoder feedback option, and English- or metric-mounting hardware standards.

1. Promega, “Personal Capillary Electrophoresis System Performs Sanger Sequencing and Fragment Analysis,” Press Release, Sept. 1, 2020.
2. Thermo Fisher Scientific, “Thermo Scientific Tundra Cryo-TEM Democratizes Cryo-Electron Microscopy, Extends to Users of Any Experience Level,” Press Release, Nov. 18, 2020.
3. AMETEK Brookfield, “AMETEK Brookfield Launches the Vapor Pro XL Autosampler, Offering Chemical-Free Moisture Analysis,” Press Release, Nov. 25, 2020.
4. Enzo Biochem, “Enzo Launches Portable Microplate Reader for Use With its Elisa and Assay Kits to Simplify Laboratory Workflow,” Press Release, Nov. 5, 2020.
5. AMETEK, “Haydon Kerk Pittman Launches the MiniSlide MSA Series of Linear Actuators,” Press Release, Oct. 7, 2020.

The latest advances in compact lab equipment include a benchtop CE instrument, a cryo transmission electron microscope, a Vapor Pro XL Autosampler, a portable microplate reader, and a compact linear actuator.

What’s New in Compact Lab Equipment

Three New Jersey teens are aiming to aid the pharmaceutical supply chain, one unused medication at a time.

The Altrui Foundation is a non-profit organization dedicated to redirecting unused medications to communities in need. Middletown, NJ residents and founders of the organization, Sourish Jasti, a freshman at the Wharton School of the University of Pennsylvania, Shreya Kavuru, a senior at St. Paul’s School in New Hampshire, and Rahul Kavuru, a junior at St. Paul’s School, formulated the plan in March of 2020 while spending time together before the COVID-19 pandemic began.

“We were having this conversation about how there’s a big problem in the supply chain where billions of unused medications are going to waste each year and pharmacies are spending about $1 to $3 per pound to discard these medications,” Shreya Kavuru says. “At the same time, there are millions of uninsured patients all over the world who are going without the medications they need. We identified this problem and started thinking about how we can play a role in this supply chain.”

The students got to work and decided to make The Altrui Foundation a center point between the manufacturers of the unused medications and the charitable organizations that seek them.

“Charitable organizations request manufacturers’ [medications] whenever there is something wrong. So, if a hurricane hit a certain part of the world, and they needed certain medications, they would reach out to whatever manufacturers that they had connections to,” Jasti says. “Sometimes they’d have strong relationships, other times it would just be cold calling. So, it was a long, messy, process and it was a hassle on both sides.”

According to Jasti, when using The Altrui Foundation, manufacturers provide an inventory list, and the charitable organizations compile medication requests and send them to the foundation. The foundation then serves as a middle ground between the two by transferring the unused medications to the charitable organizations, eliminating the uncertain back and forth between the two parties.

“We’re basically able to complete an inventory list of short-dated products by working with multiple people,” Jasti says. “We keep the sanctity of the direct relationship between the two, so we never touch the product, and we don’t have to go through the regulatory hurdles and the tax deductions at the end of the year. We’re handling the data behind it and our value proposition is a platform to facilitate both sides.”

As of December 2020, the team has shipped more than 12 million medications for Rising Pharmaceuticals, Ingenus Pharmaceuticals, Aurobindo, Camber Pharmaceuticals, Hetero, and Ascent Pharmaceuticals, and the number is growing rapidly. Jasti credits the foundation’s success to its dedicated team.

“We have people on the operations side working with excel sheets, and people working on the outreach with manufacturers and organizations. We also have some really talented people who are in photography and handle our social media,” he says. “We’re trying to give opportunities to people who want to get themselves involved. We could be doing a lot of this with fewer people, but we think that people bring in their own perspectives and their own ideas and it helps to make a really collaborative environment.”

Overall, the students want The Altrui Foundation to serve as a gateway for new initiatives in the pharmaceutical space.

“We’re able to solve two problems in society, which is, one, to allow patients to have an accessible outlet to medications and, two, to help the environment not suffer as many environmentally unfriendly, harmful effects,” Rahul Kavuru says. “This foundation can open the door for different initiatives, and this is just the beginning, so hopefully, with this project, we can create different initiatives that can really help the world and tackle its most pressing needs.”

The Altrui Foundation is a non-profit organization that serves as a center point between manufacturers of unused medications and the charitable organizations that seek them.

New Jersey Students Launch Foundation to Transfer Unused Medications to Communities in Need

Taking the time to comply with lab data integrity practices during the COVID-19 pandemic in a resourceful and operative manner is crucial for pharmaceutical laboratories. 

spoke with Bob Voelkner, vice president of Sales and Marketing at LabVantage Solutions; Charles Fracchia, CEO of BioBright and vice president of Data, Dotmatics; John Maier, director of labs data management at PPD Laboratories; and Kimberly Remillard, senior manager of Regulatory Affairs for Digital Science at Thermo Fisher Scientific about the best practices for lab data integrity during the COVID-19 pandemic.

 Are there any new regulations regarding lab data integrity? How do current and/or new regulations apply to research going on for COVID-19 therapies?

 The most recent regulations or standards for data integrity came in 2018, when FDA published updated guidance for industry on ensuring data integrity and compliance with CGMP [current good manufacturing practice] (1). At the same time, the World Health Organization and [the United Kingdom’s] MHRA issued guidance on data integrity, which is largely in line with FDA’s (2, 3). Today, the need for organizations dealing with COVID-19 to comply and adhere to the FDA guidance is no different than any other organization developing and manufacturing new drug products. The goal of data integrity is to assure the safety of, and therefore increase the confidence in, all pharma products being created and produced. Data integrity takes on heightened importance, as new COVID therapies and vaccines are on the fast track to market and prospective patients want assurances of the integrity of the drugs being offered to them. Operating a compliant lab in this environment, with data integrity at its foundation, is vital.

 (1), defines data integrity as ‘the completeness, consistency, and accuracy of data.’ While there haven’t been any new regulations regarding lab data integrity, the good clinical practice (GCP) principle that requires data to be attributable, legible, contemporaneous, original, accurate, and complete (ALCOAC) applies to all clinical trials including ongoing research for COVID-19 therapies. In order to meet the accelerated timelines of COVID-19 trials, study setup timelines have been minimized while maintaining data integrity by employing innovative technologies and processes such as:

A single global lab database to eliminate the need to merge and harmonize data

Simplified protocol definitions to improve study database quality and shorten startup timelines

Interactive web-based portals for investigators with electronic lab requisitions to significantly improve the completeness and accuracy of the data on entry

Interactive web-based portals and dashboards to enable study sponsors and project teams to monitor study wide data in real time

Powerful interfaces that combine lab data with the clinical development database in real time and continuously cleanse the data to streamline study closeout.

 In response to COVID-19, researchers and regulators have found it necessary to adjust priorities and protocols to meet new restrictions and practices for researchers, patients, and healthcare workers. Several guidance documents have been published to provide direction on how to adjust to the new conditions while maintaining data integrity and patient safety. The guidance documents make it clear that the same ALCOA+ data integrity principles apply in addition to ensuring patient safety, protection of personal data, and data validity for any trial interruptions or protocol changes. With interruptions in protocols and new remote methods of monitoring being utilized, data integrity is becoming even more critical to ensure research data maintains its validity.

Specific documentation is required to detail why protocol changes, deviations, or alternative processes are implemented, including why protocol-specified data may be missing. All alternative approaches must maintain trial participant safety and trial data quality and integrity, while minimizing missing data.

In addition to changes needed in the clinical trial and research space, fast track Emergency Use Authorizations allow for exemptions from certain GMP controls in the manufacturing area. Data integrity is critical to help reduce risk with the use of these GMP exemptions. For example, data integrity to show traceability and adequate control of source materials, data around batch records, and testing must be in place. Validation to support the consistency of the manufacturing process, including computerized systems validation, is also critical to ensure data integrity can be maintained.

Applying data integrity principles during the research and development of COVID-19 therapies to ensure the data complete, accurate, consistent, trustworthy, and reliable will support regulatory submission efforts and contribute to patient safety. Digitalization of the laboratory with integrated technologies such as a laboratory information management system (LIMS) to manage the workflow of data can add efficiency and traceability and help to ensure data integrity principles are met.

How challenging or difficult is it to comply with lab data integrity regulations during the COVID-19 pandemic?

Accelerated startup and overall timelines of COVID-19 trials have presented a significant challenge to ensuring compliance with lab data integrity regulations. We have been able to significantly reduce our setup timelines by utilizing specialized global rapid implementation teams along with the innovative technologies and processes previously mentioned.

During study execution, the sheer volume of subject and sample data collected within the condensed timelines has made real-time data monitoring and reconciliation critically important to the success of COVID-19 trials. To facilitate this, we have implemented innovative analytical tools that proactively monitor study data integrity and notify lab and clinical teams of investigator and procedural non-compliance before it impacts timelines.

During the COVID-19 pandemic, new protocols and methods for monitoring are often necessary and need to be implemented quickly. More remote data collection and management activities are occurring in the effort to minimize risk of COVID-19 for researchers, trial participants, and manufacturers alike. Due to this, it is critical that data integrity is maintained to ensure the validity of the study data as well as the protection of the patient information. Digitalization of the laboratory workflow using validated systems can reduce the risk of data integrity issues. Permission controlled systems with controlled workflows, integration to reduce potential points of human error, access across sites, and enhanced security features can all work together to support the data integrity and validity of research data. Use of secure cloud-based LIMS systems can help to connect not only the instrument data within your lab, but also allow for connectivity between sites.

I would argue it’s really only challenging or difficult for those labs that aren’t equipped with the right tools and solutions. Lab-dedicated software, like an LIMS, is designed to ensure the integrity of all the data gathered by the system. This includes dynamic auditing, so even data in temporary memory is audited prior to being committed to permanent/durable memory. These automated, connected LIMS eliminate manual data entry and risks of transcription errors or purposeful manipulation of data.

Largely speaking, because the regulations haven’t changed, the compliance hasn’t changed either. There are COVID-19 specific challenges that have arisen, largely due to the fact that fewer people are working on site, personnel density restrictions, access to certain facilities (in particular manufacturing) has been heterogeneous from company to company, and even between sites of the same company. Challenges of this kind have affected our industry particularly hard due to the acute need for the work itself. It is certain that the importance of having a safe and efficacious vaccine, alongside the politicization of the vaccine availability, have negative effects on the environment surrounding the development. Even before the pandemic hit, there have been reports of data integrity bypasses and fraud. Pressure due to the pandemic has only increased existing trends in this environment and combined with a generalized lowering of the public’s trust in any vaccine, this makes data integrity and compliance a crucial aspect of the response.

How do you suggest other organizations improve/enhance their lab data integrity activities (specifically, workflow, day-to-day operations, etc.), and how can this particularly help companies that are trying to develop a COVID-19 therapeutic?

 Data integrity relies on a combination of people, technology, and processes. Robust processes are necessary to ensure consistency and quality assurance. A good culture of quality will help to ensure the human resources involved in the laboratory will execute the processes in the correct way. And the right technology to meet the needs of the laboratory and regulations such as 21 

] Part 11 can help to reduce the risk of human error and process deviations.

Whenever possible, integrating the laboratory with validated digital systems to meet your workflow needs will help to reduce the risk of data integrity issues. The same principles will apply whether digitalized or not; however, more checks and monitoring may be required for systems which are not digitally controlled. Ensuring all data specific and attributable, including clearly and specifically documenting any changes or missing data, is key to be able to show the integrity and validity of your data.

 In order to improve lab data integrity activities, companies must review their existing practices and replace wherever possible error-prone, manual steps in the reporting of results and tracing of individual steps. With a robust, automated, informatics system taking care of recording and tracking vital laboratory or manufacturing information, a company can reduce the chances of having data integrity issues. Crucially, companies must also assess their systems’ cybersecurity posture, because with increased automation and informatics also comes a potential for external manipulation. Unfortunately, the vast majority of bioinformatics or laboratory informatics tools have very poor cybersecurity practices and hygiene and create a large opportunity for third parties to steal and modify data in said systems, and understanding the weaknesses and avenues that could cause deviations or data manipulations are absolutely key for companies. This is particularly true if —as the FBI has warned (4)—the company has publicly announced efforts in search of a COVID-19 therapeutic. Finally, we strongly recommend that companies set up a process to review new data and results that are being put into the record. This practice, common in clinical environments, needs to be performed by a person who is not familiar with the specific experiment, ideally even a disinterested third party. This will create human oversight and catch errors such as missing data, ambiguous results, unsupported conclusions, and more. Enacting this practice will ultimately give the executives, the company’s team, and even the public a level of safety in trust in the result that is sorely needed in this moment.

 Organizations can improve lab data integrity by implementing systems and processes that reduce the level of effort to set up and validate the lab database by utilizing a single global database; limit the amount of data captured to only those elements required for analysis; employ robust quality controls that QC [quality control] data on entry, when modification are made and prior to reporting; and provide innovative web-based tools that facilitate electronic data capture (electronic lab requisitions) and real-time data access to investigators and clinical team members for continuous data review and reconciliation.

 One critical way to ensure product quality is to prevent data integrity lapses at the outset, so proper lab automation is key. For companies that have abandoned traditional, paper-based record-keeping practices or deficient legacy IT systems, in favor of preconfigured and prevalidated LIMS built specifically for today’s regulated labs, they’re already on the right track. Such a LIMS enables automated connection to lab instruments so that results can be directly recorded into the LIMS, not only speeding the process, but increasing data integrity.

It’s worth noting that modern LIMS, which should be 100% browser-based, can help lab directors and managers to physically distance laboratorians who can work with tablets or other mobile devices.

 What trends are driving the need for data integrity in the laboratory setting?

 Besides the politicization and fraught recent history of data integrity that was discussed above, the next most important trend affecting data integrity is the deluge of data that is now commonplace in our industry. In processes where thousands of data points per day was the norm, we now routinely see workflows that generate millions of data points per day, both qualitative ones (such as images) and quantitative ones (e.g., assays). This dramatic uptick in data volume is a blessing for data-driven research, but it is also an unprecedented challenge to verify, validate, and commit [these] data to record. The need for automated tools is now clear, and such tools must be aware of automation capabilities and be hardened against cyber manipulations or we risk the robustness and trust of the whole system in this transition.

 The continuous push to bring therapeutics to market quicker and more cost effectively will continue to drive innovation and system integration throughout all phases of the clinical trial life cycle and in the laboratory setting, to ensure data integrity is maintained. We will continue to develop improved analytical tools and are beginning to explore artificial intelligence predictive models to improve subject, site, sponsor, and lab compliance, which in turn will help enhance data integrity, reduce study timelines, and ultimately drive down costs.

Data Integrity and Compliance with Drug CGMP

, www.fda.gov, accessed Nov. 9, 2020.
2. MHRA, 

‘GXP’ Data Integrity Guidance and Definitions

, www.gov.uk, accessed Nov. 9, 2020.
3. WHO, 

, www.who.int, accessed Nov. 9, 2020.
4. CISA, “FBI and CISA Warn Against Chinese Targeting of Covid-19 Research Organizations,” Press Release, May 13, 2020.


Vol. 44, No. 12
December 2020
Pages: 36-40

When referring to this article, please cite it as L. Lavelle, “Complying with Lab Data Integrity Practices During COVID-19,” 

Pharmaceutical laboratories must keep lab data integrity practices in mind in order to properly handle the effects of the COVID-19 pandemic.