Jill Murphy

Colbert Packaging announced its new robotic solution for product palletization operations on Sept. 27, 2023. The new customized system is designed for fully automated and integrated labeling, orientation, and palletization, and it is expected to streamline the current manual processes, according to the press release.

Partnering with RoBEX, Colbert is aiming to continue to assess operational challenges and identify solutions to pick and palletize multiple case variations and pallet configurations. Further, RoBEX’s solution included a design blueprint, integration plan, and meticulous cycle time calculations before final implementation.

“Our pharmaceutical and consumer goods customers expect their secondary packaging supplier to invest in technology to maximize capacity and capabilities, and improve quality and responsiveness,” said John Lackner, Colbert President & COO, in a press release. “In keeping with the ‘Expect Innovation’ theme at Pack Expo this year, we look forward to introducing and utilizing this innovative investment in technology to enhance our operations and our customer experience.”

Some of the key features according to the release include:

● Multifunctional Pallet Handling- the adaptability allows for smoother transitions between various pallet types, optimizing the workflow and reducing system downtime. Efficient pallet loading and alignment is essential for smooth operations, and with the new system, every pallet pack is done with precision.

● Automated Labeling - This dual function ensures products are correctly oriented for palletizing, shipping and storage, streamlining subsequent handling stages and meeting the various customer specifications.

● Superior Tracking Capabilities- Integration of sequential barcodes on each pallet ensures meticulous and automated lot control for product traceability. This level of detail provides controls for Colbert and its customers.

● Safety First - This fosters a more sustainable work environment, decreasing physical strain for associates, reducing turnover and offering alternative options for associates.

"This collaboration with Colbert was both challenging and inspiring. Together, we’ve managed to craft a solution that optimizes pick-and-pack operations, addressing existing challenges and paving the way for future innovations,” said Rob Johnson, RōBEX Director of National Accounts, in a press release.

Source: Colbert Packaging (PDF press release)

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The new customized system is designed for fully automated and integrated labeling, orientation, and palletization, and it is expected to streamline the current manual processes, according to the press release.

Updates from Colbert Packaging at Pack Expo 2023

BenevolentAI, a company that is a part of the development of advanced AI to accelerate biopharma discovery, announced on Sept. 20, 2023 that it has signed a strategic collaboration with Merck.

This collaboration will help Merck leverage BenevolentAI’s AI platform capabilities and access a team of interdisciplinary drug discovery scientists to identify and develop innovative compounds through Hit Identification, or Hit ID, to the pre-clinical stage. Further, BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

The terms of the agreement outline that BenevolentAI will be eligible for payments of up to $594 million, which consists of a low double-digit million dollar upfront payment on signing and then potentially discovery, development, and commercial milestones, according to the release. Further, tiered royalties will also be payable on net sales of any commercialized products.

“Our strategic collaboration with Merck exemplifies BenevolentAI’s unique capability to leverage AI to accelerate drug discovery. Our proprietary technology and extensively validated approach of combining AI, molecular biology, medicinal chemistry, and in vivo pharmacology supports the discovery of innovative drug candidates in fewer cycles,” said Joanna Shields, chief executive officer of BenevolentAI, in a press release. “We look forward to working with the Merck team and are excited at the opportunities in our partnership.”

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

BenevolentAI Signs Collaboration with Merck

The drug development partnership between Evecxia Therapeutics and Quotient Sciences has seen the success of a Phase I clinical testing program for Evecxia’s drug candidate EVX-101, which is in development to treat major depressive disorder (MDD).

According to the release, Evecxia is the first company dedicated to realizing the therapeutic potential of amplifying serotonin synthesis to treat brain disorders such as MDD. The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

EVX-101 is a novel, proprietary, sustained-release tablet formulation of 5-hydroxtryptophan, or 5-HTP, the natural precursor to serotonin, and low-dose carbidopa. Further, 5-HTP is the active compound and carbidopa functions as an absorption enhancer for 5-HTP.

The new EVX-101 drug candidate into a Phase II adjunctive treatment study in patients with MDD who are responding inadequately to a first-line SSRI/SNRI antidepressant.

“Quotient Sciences’ expertise in developing and optimizing modified-release formulations coupled with their ability to integrate rapid clinical assessments allowed us to produce a new drug candidate, EVX-101, in a highly condensed time frame,” said Jacob Jacobsen, PhD, CEO of Evecxia, in a press release. “We are very pleased with the outcome of this partnership and appreciate the collaboration between both organizations to aid in the advancement of EVX-101 towards helping patients who are suffering from the life-limiting effects of MDD.”

Mark Egerton, PhD, CEO of Quotient Sciences, added how the partnership with Evecxia has greatly accelerated the development timeline of their EVX-101 program. “Improving mental health is a global goal and the industry must work hard to get treatments to patients more quickly,” he said in a press release. “We are proud that this collaboration and our expertise has enabled Evecxia to successfully progress EVX-101 onward into Phase II studies to provide patients who are suffering from MDD with new treatment options.”

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

Evecxia Therapeutics and Quotient Sciences Complete Phase I Clinical Milestone

A major revision of the International Council for Harmonisation’s (ICH) Q9 (R1) was published earlier in 2023, and the updates help to gain an understanding of lifecycle management, training materials, and other insights important to the industry, according to a session at the 2023 PDA/FDA Joint Regulatory Conference in Washington, DC (1).

In the session “The New ICH Q9 Guideline: The Next Generation of Quality Risk Management,” Alex M. Viehmann, division director, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), FDA, and Denise M. DiGiulio, head of Global Audit and Inspection Management, Genentech, both gave an overview of the changes to ICH Q9 (R1) and the lifecycle management of risks to ensure an ongoing state of control.

https://www.pharmtech.com/view/quality-quartets-in-risk-based-qualification-ich-q9-r1-considerations

https://www.pharmtech.com/view/navigating-the-formality-spectrum-in-ich-q9-r1-

https://www.pharmtech.com/view/knowledge-as-the-currency-of-managing-risk-a-smart-investment-for-patients 

Viehmann dived into the milestones of ICH Q9 R1, including the revision topics of subjectivity in quality risk management (QRM), product availability risks, formality in QRM, risk-based decision making, risk review, and hazard identification. As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9. Although this cannot be fully eliminated, it can be controlled by addressing bias and assumption with the proper use of QRM tools and use of relevant data.

Another example of a revision Viehmann went over is formality, in which many of those in the industry, including regulators, have a lack of understanding and uncertainty surrounding the topic. “This was a big revision topic because we wanted to get rid of the concept of formality, like there is informal versus formal,” he said. The ICH Q9 R1 addresses this issue with the inputs of complexity, importance, and uncertainty, which should lead to the proper resources for QRM activity to be used more efficiently.

According to DiGuilio, QRM includes taking into account new knowledge and experience and certain lifecycle events that can impact the original quality risk management decision. This may trigger risk review, as processes need to be reevaluated to continue to be improved, and the knowledge we gain through experience after initial launch and commercial manufacturing can help the improvements align with ICH Q10.

In a case study example, DiGuilio described the role of QRM in an aging facility, as it downgraded from an initial qualification site with highly formal QRM experts and knowledge in a state of control to facility deterioration, with no upgrades to technology or any upkeeping due to a lack of knowledge in 10 year’s time. This also impacted the long-term cost and product availability, which needed a resolution. DiGuilio explained how a critical senior management role to maintain ongoing oversight to ensure sustainability of operational design, control, maintenance, repairs, and more can be beneficial.

There are also early warning signals, such as increase in equipment issues, higher levels of deviations, and a reactive management, because these concepts cannot ensure quality performance. As for implementing ICH Q9 (R1) in the industry and not in the case study, DiGuilio said how QRM is not a one-time activity, it is what the industry does on a daily basis. “I think it’s about creating a culture regulatory compliance and following risk awareness, and understanding that QRM isn’t really a one-time activity,” she said.

DiGuilio, D; Viehmann, A. The New ICH Q9 Guideline: The Next Generation of Quality Risk Management. Presentation at the 2023 PDA/FDA Joint Regulatory Conference, Washington, DC, Sept. 18–20, 2023.

As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9.

ICH Q9 R1 Hits Major Milestones for the Pharmaceutical Industry

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Promoting compliance, regulatory and enforcement actions, and organizational excellence, while practicing voluntary compliance are some of the ways that top leaders in the space can be vigilant when looking at recent actions and inspections, according to a session at the 2023 PDA/FDA Joint Regulatory Conference in Washington, DC (1).

In the session “Compliance Office Updates,” Melissa J. Mendoza, JD, acting director, Office of Compliance and Biologics Quality, Center of Biologics Evaluation and Research (CBER), FDA, and Jill Furman, JD, director, OC, Center for Evaluation and Research (CDER), FDA, both shared their updates from CBER and CDER and the initiatives that their organizations have taken to combat regulatory challenges and enforcement strategies.

According to Mendoza, CBER has been adjusting to significant leadership and organizational changes for the past two years, including a new office, called “The Office of Therapeutic Products,” that was developed following the reorganization of the Office of Tissues and Advanced Therapies. Further, she reiterated the end of the COVID-19 Public Health Emergency on May 11, 2023, which is different from the Emergency Use Authorization of COVID-19 vaccines that have updated on Sept. 11, 2023. The vaccine updates include a monovalent component that corresponds to the omicron variant.

Mendoza discussed how many good manufacturing practice (GMP) warning letters have been addressed this past year, specifically with firms that are manufacturing biologic products that are unapproved and unlicensed and/or violate GMP, such as umbilical cord blood issues or amniotic fluid eye drops, which are a very concerning and significant safety concern for FDA now. Raw material control and testing and lab controls are also included in the top GMP complaints, according to Mendoza. “Compliance work will reveal certain trends and products that are available that require a public safety alert,” she said. Although there are very public actions taken, such as recalls, letters, and statements, that CBER participates in when there are compliance issues, Mendoza emphasized that there are a lot more things that go on behind the scenes that are intended to prevent the need to take even more compliance action in the first place.

As for CDER, Furman defined the organization’s mission to shield the public from poor quality, unsafe, and ineffective drugs through proactive compliance strategies and risk-based enforcement action. “There are many persistent and emerging risks in each of the areas that we regulate, and confronting each individual risk requires thoughtful planning and the right regulatory approach depending on the circumstance,” she said.

Furman continued by describing how recent activities have happened to promote voluntary compliance, which means being transparent with the public and using feedback/data towards decisions. For example, there are numerous pieces of guidance related to compounding, clinical trial oversight, and the Drug Supply Chain Security Act, and stakeholder feedback is a critical component to all these areas. She also mentioned how resources like FDA’s data dashboard, holding public meetings with stakeholder feedback, and trainings to develop more for compliance are all beneficial. “We want to remain nimble in order to respond to emergencies rapidly and effectively,” she said.

Furman, J; Mendoza, M. Compliance Office Updates. Presentation at the 2023 PDA/FDA Joint Regulatory Conference, Washington, DC, Sept. 18–20, 2023.

Leaders at CDER and CBER give update on organizational changes at FDA.

Staying Compliant in 2023

Treating change as a normal condition of organizations and utilizing new information that is taught to our organizations are two key components to making innovations in current good manufacturing practice (CGMP) training, according to a session at the 2023 PDA/FDA Joint Regulatory Conference in Washington, DC (1).

In the session “Innovations in CGMP Training,” Nkiruka Ogbuchiekwe, senior director, Leadership, Management, and Culture, Moderna University at Moderna, and Nicole King, associate director, GMP Training Transformation at AstraZeneca, both shared their experiences with transforming companies into learning organizations and what needs to happen to get to this point.

Ogbuchiekwe explained how learning culture must evolve, as it can be described as a “shift toward manifestation of how people in an organization experience the constant exchange of values, mindsets, and behaviors the harness the power of change.” These people are also either responsible for taking advantage of change or predicting it. “Change is happening, and if we are not actively building people today to be able to understand the nature of change, then we are failing in the learning and development profession,” she said.

In an example that happened at Moderna, Ogbuchiekwe said how she was able to help the company build a learning culture and experiment with data to feed back into the new learning culture model. Although these methods worked for Moderna, she emphasized that other organizations can’t take their exact learning plan and use it somewhere else; professionals must sit down, scan the environment, and see what is going on and what needs to be accomplished.

The team ended up creating Moderna University from a case study, which was developed as an intersection of a physical campus, digital platform, industry learning center, and cultural hub. The other case study Ogbuchiekwe described went into a modern twist of a risk assessment, which is a “frame-by-frame” model with risk profile-based training curriculum. “People deserve training experiences that are aligned with what we know about how adults learn best- interactive, incorporate different ways of learning,” she said. These types of learning changes save time, create no misalignments within the organization, and can bring back collaboration and more valuable items for employees.

For King at AstraZeneca, a major issue that the organization has seen is going through new employee orientation and assigned standard operating procedures (SOPs) just to “check a box” and end up burning out. These types of onboarding activities with no context do not equal competency, understanding, or confidence, according to King, which AstraZeneca aimed to solve. Something King learned is to always demand to know the reason for the requirement for a training. “Whenever I go in somewhere and I ask to do something, sometimes a minor change, sometimes a more radical change, I always ask, ‘what is the requirement?’,” she explained.

After implementing this, one can discuss about how they interpret the requirement and what is best for the patient or organization, since this gives anyone the opportunity to reset any regulation that exists, according to King. AstraZeneca, for example, is participating in the GMP Education & Training Uplift Project (GETUP) which is fundamental in terms of how someone is trained. The manager can decide which asset is needed for an employee and then that person is trained on that solely, while SOPs are organized to be accessed at any time but not necessary in everyday training. King also described how AstraZeneca is set on creating a universal set of requirements, which is one global SOP that everyone can follow to avoid extra documentations and other iterations of the same documents.

“I know we sit in offices sometimes and we know how things are, we base it on our experience maybe 6, 7, 10, 15 years ago … please go see. Please go see your employees and ask what they remember, what’s been effective and what’s not, and start asking people ‘show me the requirement,’” King said. Additionally, being a champion for change with those who are open minded and gathering as much data as possible can also be beneficial to creating a successful learning community.

King, N; Ogbuchiekwe, N. Innovations in CGMP Training. Presentation at the 2023 PDA/FDA Joint Regulatory Conference, Washington, DC, Sept. 18–20, 2023.

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference. 