Susan Haigney

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The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended 17 drugs for market authorization at its December meeting, EMA announced on Dec. 13, 2024. The approvals include five orphan drug recommendations and six biosimilar recommendations.

Among the approval recommendations is a monoclonal antibody, Kavigale (sipavibart), for COVID-19 prevention in immunocompromised people aged 12 and older. “Following the recommendation for approval of Kavigale, EMA’s Emergency Task Force (ETF) has issued an updated statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants and recommends healthcare professionals to check the current epidemiological situation in their region,” the agency stated in a press release (1). Kostaive (zapomeran), a self-amplifying messenger RNA vaccine, was also recommended for the prevention of COVID-19.

Orphan drugs recommended by CHMP include the following:

Andembry(garadacimab), which prevents recurrent attacks of hereditary angioedema

Beyonttra (acoramidis), which treats a wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy

Rytelo(imetelstat), which treats adults with transfusion-dependent anemia due to very low, low, or intermediate risk myelodysplastic syndromes

Seladelpar Gilead(seladelpar lysine dihydrate), which treats primary biliary cholangitis

Emcitate(tiratricol), which treats peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome.

The following six biosimilars were recommended for authorization:

Avtozma (tocilizumab) was given positive recommendation for treating rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, chimeric antigen T cell (CAR-T cell)-induced severe or life-threatening cytokine release syndrome and COVID-19.

Eydenzelt (aflibercept) treats eye diseases such as neovascular age-related macular degeneration, macular oedema secondary to retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularization.

Osenvelt (denosumab) prevents bone complications in adults with advanced bone cancer and treats adults and skeletally mature adolescents with giant cell bone tumors.

Stoboclo (denosumab) treats osteoporosis in menopausal women, bone loss linked to hormone ablation in men at increased risk of fractures, and bone loss associated with long-term treatment with systemic glucocorticoid.

Yesintek (ustekinumab) treats adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease.

Zefylti (filgrastim) treats neutropenia and the mobilization of peripheral blood progenitor cells.

Other positive opinions given by CHMP include:

Nemluvio (nemolizumab), which treats atopic dermatitis and prurigo nodularis

Welireg(belzutifan), to treat tumors associated with von Hippel-Lindau disease and advanced clear cell renal cell carcinoma

Paxneury (guanfacine), which treats children with attention-deficit hyperactivity disorder

Tuzulby (methylphenidate hydrochloride) to treat children with attention-deficit hyperactivity disorder.

The December recommendations bring the total of drugs recommended for approval by CHMP for 2024 to 114.

CHMP also extended recommendations for several drugs, including Ofev for the treatment of progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents, Blincyto, Bridion, Flucelvax Tetra, Jemperli, Omvoh, Rekambys, and Vocabria.

Also during the December meeting, CHMP chose to withdraw Alofisel (darvadstrocel) from the market after data showed its effectiveness was not what had been anticipated. Alofisel had been approved to treat complex anal fistulas in adults with Crohn’s disease.

Meeting highlights from the Committee for Medicinal Products for Human Use(CHMP) 9-12 December 2024

Articles

EMA recommended 17 drugs for marketing authorization in December, including treatments for rare heart conditions, anemia, and liver disease.

Several Orphan Drugs Among Medicines Recommended for Approval by EMA in December

FDA announced on Dec. 12, 2024 that the Center for Drug Evaluation and Research (CDER) has created a Center for Real-World Evidence Innovation (CCRI). The CCRI will coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) when making regulatory decisions at CDER (1).

Patient health data from sources such as electronic health records, medical claims, and product and disease registries are considered RWD. Real-world evidence can be generated from this RWD to provide insight into the effectiveness of drugs. According to FDA, patient data has increased in volume and complexity during the past few decades, this data has transformed the way drugs are developed, manufactured, and used. The CCRI will advocate, coordinate, and promote these data within CDER including initiatives related to emerging technologies.

"CDER’s new Center for Real-World Evidence Innovation represents a major step forward in our efforts to unlock the full potential of RWD to inform clinical and regulatory decisions," said CDER Director Patrizia Cavazzoni, MD (2). "We are creating a focal point within CDER to identify ways in which we can utilize RWE to streamline the development of effective and safe medicines for conditions with unmet need."

In 2023, FDA published its guidance on RWD,

Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products

on how to design a registry or use an existing registry to support regulatory decision-making about the safety and effectiveness of a drug (3). The guidance includes information about a registry’s fitness-for-use, linking a registry to other data sources for supplemental information, and supporting FDA review of submissions.

The guidance defines a registry “as an organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or drug exposure.” Real-word data are defined in the guidance document as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWE is defined by FDA as “the clinical evidence about the usage and the potential benefits or risks of a medical product derived from analysis of RWD” (3).

FDA isn’t the only regulatory body utilizing RWD in decision making. In Europe, the European Medicines Agency (EMA) promotes using RWD as part of its Regulatory Science Strategy of 2025 (4). The agency plans on creating a framework to delivery and analyze RWD during a product’s lifecycle. It will then implement processes to use these data in regulatory assessments. EMA also published RWD catalogues in March 2024 to help regulators, pharma companies, and researchers to use RWD for determining the safety and effectiveness of drugs. And in April 2024, EMA released guidance on the types of studies that can be used to perform RWE generation (4).

1. FDA. CDER Center for Real-World Evidence Innovation (CCRI). 

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-real-world-evidence-innovation-ccri


2. FDA. CDER Establishes New Center for Real-World Evidence Innovation. 

https://www.fda.gov/drugs/drug-safety-and-availability/cder-establishes-new-center-real-world-evidence-innovation

Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products 

(CDER, CBER, December 2023).
4. Barton, C. Using RWD in Non-Interventional Studies. 

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

FDA Creates CDER Center for Real-World Evidence Innovation 

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

TekniPlex Healthcare, a contract development and manufacturing organization, announced on Dec. 12, 2024 that it will be showcasing expanded capacity and capabilities of its injection blow molded bottles and five-layer blown film at the Pharmapack Europe event in Paris on Jan. 22–23, 2025. The company will also be featuring its sustainability-minded blister packaging and coated polyvinyl chloride (PVC) structures.

The company has added substantial injection blow molding capacity for multidose vial packaging at its Modena, Italy, facility. The capacity will allow the company to support pharmaceutical liquid applications including ophthalmic products. TekniPlex’s standard bottles range from 5–30 mL and are manufactured in ISO 8 cleanrooms.

TekniPlex Healthcare’s vertical bellow bottles, used for surgical powders and wound management, come in 3 mL or 9 mL volumes and have tamper-evident cannula caps that eliminate the need for secondary packaging. The bottles can be customized with silk screening and color variations.

The company is also expanding its production of multilayer brown film and cleanroom bags at its Puurs, Belgium, facility. Extruded blown films and bags with up to five layers, with a particular focus on polyethylene–ethylene-vinyl alcohol–polyethylene (PE-EVOH-PE) constructions providing exemplary oxygen barrier properties, are now available. According to TekniPlex, the market is shifting away from conventional food-grade materials to higher-grade resins. “These high-leverage materials are then used for cleanroom-produced films and bags manufactured in accordance with GMP [good manufacturing practice] guidelines,” the company stated in a press release (1).

In addition to these increases in capacity, the company will also be showcasing its range of sustainable blister packages at Pharmapack Europe, including a pharma-grade blister film with 30% post-consumer recycled content on a mass balance basis. A fully transparent recyclable mid-barrier blister package will also be exhibited by the company. The package features a polyolefin blister film paired with a barrier polypropylene lidding film. According to the company, this is the first time a formed blister plus lidding combination with moisture barrier has been made recyclable.

The company will also exhibit its pharma rubber compounding and manufacturing solutions. “Manufactured to precise dimensional tolerances to ensure proper fit and function within packaging or medical devices, the company’s pharma-grade rubber substantially minimizes the risk of migration-associated impurities [such as] extractables and leachables,” the company stated in the release. Additionally, the company’s Flexapharm SBC series of PVDC (polyvinylidene chloride) coated PVC structures and Aclar laminates will be on display.

TekniPlex can be found at Stand E97 at Pharmapack Europe, Jan. 22–23 in Paris, France.

Earlier in 2024, the company unveiled the HPC74 Series, a reinforced paper for medical device packaging applications, at Pack Expo 2024 in Chicago (2). The paper is breathable, has several coating formulations, a clean peel, and has the highest puncture and tear strength of all of the company’s previous reinforced papers.

TekniPlex. At Pharmapack Europe, TekniPlex Healthcare to Tout Expanded Capacity for Injection Blow Molded Bottles and Five-Layer Blown Film. Press Release. Dec. 12, 2024.

Lavery, P. TekniPlex Healthcare Announces Offerings on Display at Pack Expo 2024. 

The company will be showcasing its injection blow molded bottles and five-layer blown film at the packaging event in Paris on Jan. 22–23, 2025.

TekniPlex Healthcare to Announce Expanded Capacity at Pharmapack Europe

The Impact of USP Chapter <86> on Endotoxin Testing

The US Pharmacopeia (USP) published Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents into the

 United States Pharmacopeia–National Formulary (USP–NF) 

The chapter permits the use of non-animal-derived reagents for endotoxin testing and is part of USP’s commitment to expanding the use of animal-free methods and materials (1).

Endotoxins, which are present in the environment, can have dangerous effects if they are contained in pharmaceutical products. Gram-negative bacterial endotoxins are difficult to destroy, according to Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories. “When [endotoxins] do end up in a final product, [and] when that [product] is injected or implanted into a patient, it can lead to what we call a pyrogenic response. What that means is the human body is reacting to this contaminant, and it can cause anything from a mild fever all the way through to death. That's the ultimate circumstance of too much endotoxin. So, therefore, most pharmaceutical products that are tested for endotoxin are those that are injectable or implantable and come into contact with the bloodstream, and therefore have to have low levels of endotoxin.”

 in which Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents. 

https://www.pharmtech.com/view/non-animal-derived-reagents-for-endotoxin-testing

Currently, most manufacturers use the limulus amebocyte lysate (LAL) test to perform endotoxin testing. The LAL test is an animal-derived test, and though the animal itself is not tested upon, there is still concern about the use of animals in testing. Therefore, USP has introduced this new chapter to the 

® spoke with Reid to get her perspective on endotoxin testing and how the new USP chapter might impact the pharmaceutical industry.

Click on the video above the watch the interview.

1. USP. Expert Committee Approves Endotoxin Testing Using Non-animal Derived Reagents. Press Release. July 26, 2024.

Videos

Pharmaceutical Technology® spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, to get her perspective on endotoxin testing and USP’s new Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents.

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AbbVie announced on Dec. 11, 2024 that its acquisition of Aliada Therapeutics,a biotechnology company working to solve challenges in central nervous system (CNS) drug development, has been completed. Announced in October 2024, the acquisition strengthens AbbVie’s neuroscience pipeline and includes Aliada’s anti-pyroglutamate amyloid beta (3pE-Aβ) antibody, ALIA-1758, for the treatment of Alzheimer’s disease.

"Alzheimer's disease poses a significant public health challenge, impacting millions worldwide and is becoming more prevalent as populations age," said Dawn Carlson, MD, vice-president, neuroscience development at AbbVie, in a press release (1). "With the acquisition now complete, we look forward to advancing potentially disease-modifying therapies such as ALIA-1758 for Alzheimer's disease and bolstering our neuroscience discovery and development efforts by leveraging Aliada's novel CNS drug delivery platform."

ALIA-1758, which is currently in a Phase I clinical trial, uses a novel blood-brain barrier (BBB)-crossing technology, Modular Delivery (MODEL) platform, that enhances delivery of targeted drugs into the CNS. MODEL targets transferrin (TfR) and CD98 receptors to deliver different types of biological cargoes into the brain. ALIA-1758 uses TfR to transport a 3pE-Aβ antibody across the BBB. This enables the degradation and elimination of amyloid beta plaques, according to the company.

"Neuroscience is one of our key growth areas and we are committed to driving innovation in this field to address critical unmet needs for patients living with seriously debilitating neurological diseases such as Alzheimer's disease," said Roopal Thakkar, MD, executive vice-president, research and development, and chief scientific officer, AbbVie, in the October 2024 press release (2). "This acquisition immediately positions us to advance ALIA-1758, a potentially best-in-class disease-modifying therapy for Alzheimer's disease. In addition, Aliada's novel BBB-crossing technology strengthens our R&D capabilities to accelerate the development of next-generation therapies for neurological disorders and other diseases where enhanced delivery of therapeutics into the CNS is beneficial."

"We are pleased to announce the acquisition of Aliada by AbbVie and are excited about AbbVie's commitment to bringing ALIA-1758 to patients with Alzheimer's disease. Our proprietary MODEL platform has enabled the development of ALIA-1758, a promising step forward in brain delivery of an anti-amyloid antibody therapy," said Michael Ryan, MD, chief medical officer at Aliada Therapeutics, in the October release. "Many promising CNS-targeted therapies fail to reach late-stage trials due to their inability to cross the blood-brain barrier. Our MODEL platform addresses this challenge directly, efficiently delivering targeted drugs and potentially transforming how we treat neurological diseases."

According to the October press release, the agreement hasAbbVie gaining all outstanding Aliada equity for $1.4 billion in cash.

This isn’t the only acquisition this year for AbbVie. The company also added to its neurological pipeline in August 2024 with 

the acquisition of Cerevel Therapeutics, a clinical-stage biopharmaceutical company specializing in neuroscience diseases 

(3). The company also expanded its anti-inflammatory disease pipeline with the 

acquisition of Celsius Therapeutics in June of 2024 

AbbVie. AbbVie Completes Acquisition of Aliada Therapeutics. Press Release. Dec. 11, 2024.

AbbVie. AbbVie to Acquire Aliada Therapeutics, Strengthening Focus in Alzheimer's Disease and Neuroscience Pipeline. Press Release. Oct. 28, 2024.

AbbVie. AbbVie Completes Acquisition of Cerevel Therapeutics. Press Release. Aug. 1, 2024.

AbbVie. AbbVie Acquires Celsius Therapeutics. Press Release. June 27, 2024.

AbbVie has completed its acquisition of Aliada Therapeutics which includes Aliada’s disease-modifying therapy for Alzheimer’s disease.

AbbVie Acquires Aliada Therapeutics, Gains Neuroscience Pipeline

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People around the world rely on medicines to improve—and often save—their lives. These therapies must not only be effective, but also safe for people to use. Regulatory bodies offer guidelines and regulations to ensure medicines are properly developed and manufactured. These guidelines are commonly referred to as good manufacturing practices (GMPs), among other ‘good practices’, in the United States and are outlined in the 

) and ensured by FDA (1). In Europe, GMPs are coordinated by the European Medicines Agency (EMA) and compiled in the 

 (2,3). Knowledge and proper implementation of these guidelines is key to the production of safe and effective medicines.

For patients, a lack of quality in a therapeutic product can have a dire impact. From a business perspective, a lack of training can result in delays getting product to market, product recalls, and regulatory scrutiny. Regulators want the assurance that a company’s training is adequate. “Regulators consistently review training programs during quality inspections,” says Peter Phillips, vice president, Quality Operations, BioVectra (a part of Agilent). “This is typically examined in two contexts: either as part of an investigation into specific incidents or as a standalone area of focus. Inspectors also assess how well the training aligns with employees’ job descriptions and actual responsibilities, ensuring that staff are properly trained to perform their tasks in compliance with regulatory requirements.”

The development and manufacture of medicines, however, is a complex process that involves early development scientists, pre-marketing analysts, manufacturing engineers, quality control personnel, contract organizations, and a variety of other personnel. If these many and varied individuals are not properly trained in their individual tasks, there may be a negative impact on the final drug product.

In an example of poor training impacting drug quality, Lara Ionescu Silverman, principal consultant at LIS BioConsulting, shares the story of a company’s quality department tracking results from a new analytical method that showed a decreasing trend in one value across all evaluated materials. “After an investigation, it was determined that the operator was slowly morphing the method and did not recognize the change, which resulted in the shift in values. Due to the criticality of the test, many contract projects had to be notified and retested at great expense. This could have been avoided through more frequent retraining, operator observation, and the use of multiple operators (to more quickly reveal any issues from a single operator),” says Silverman.

Training should be a constant, living element in a bio/pharmaceutical organization to prevent these kinds of problems. “Consistent, repeatable processes are critical to ensuring a robust product and process, and these processes rely on thorough and appropriate training. This includes not only technical and equipment operation training, but also safety protocol training and regulatory requirements,” says Phillips. “If personnel are not adequately trained … and a well-structured training program put in place, it can lead to process variability, safety risks, and non-compliance,” he warns.

Development of a drug is the first step in getting a therapy into the hands of patients. This step involves choosing the building blocks of the drug, from ingredients to delivery method to process development.

“It is critical to ensure that the research and development staff understand the future activities required to get a novel biologic or small-molecule drug approved,” says Silverman. “These scientists are doing incredible work to uncover novel mechanisms, drugs, and treatments. But, if they don’t keep the end in mind, issues can arise down the road. Providing basic training on the regulatory, manufacturing, and commercialization requirements can help scientists understand future activities and drive their present-day work.”

A lack of training in those individuals involved in the development of a drug can impact the quality of that drug in a variety of ways, according to Tony Cucinella, vice president, head of Quality and Regulatory Affairs at Selkirk Pharma. He points to poor aseptic techniques as a risk factor for contamination. “This [factor] is particularly critical for biologics, which are highly sensitive to microbial contamination,” says Cucinella. Improper training of processes can lead to variability, which can lead to inconsistencies in batches of product, he reports. Proper handling and storage of materials and the final product is also essential. “Improper training can result in mishandling, degrading the drug’s efficacy and safety,” Cucinella says. Lastly, he stresses that accurate documentation is key to drug quality. “Poor training can lead to errors in data recording, which can compromise the integrity of the development process and regulatory submissions.”

Utilizing reagents and equipment properly in a GMP setting with good controls and consistency is essential, specifies Silverman. “These materials and equipment should come from reputable manufacturers and allow for large-scale production, enabling the company to meet their market size goals to achieve ultimate commercial success. Also, it is important to gather (and organize!) analytical data from the ancillary materials, the process, and the final drug substances/products to allow for future comparability as well as the development of suitable control strategies to enable efficient GMP manufacturing,” she stresses.

Errors such as choice of delivery technology can happen when a development scientist is not properly trained, according to Chris Moreton of FinnBrit Consulting. “From my own experience, such a failure can cause a delay of about two years in the time to get to a reliable Phase I clinical trial result. This would be a fatal delay for many biotech start-up companies,” Moreton says.

Cucinella stresses that a comprehensive and ongoing training program for all those involved in drug development is essential for quality. “Trained personnel are better equipped to identify and troubleshoot issues during development. Without proper training, problems may go unnoticed or unresolved, affecting the drug’s quality,” he states.

A variety of unexpected events can happen during drug manufacturing, warns Michael Pinaud, senior vice president of Operations at Ascend Advanced Therapies, that can result in a final product that is unsuitable for use. “Without proper training on how to deal with the unexpected, the result can have detrimental impact on the quality and the ability to release drug product, says Pinaud. “Training operators to follow the appropriate procedures and keep good batch records should be considered the bare minimum expectation. Capturing all the relevant information and keeping a thorough timeline of events (through investigations and real time interviews) also helps to ensure that if/when something happens, it is clear if/how the quality of final drug product might be impacted because you have a detailed record of what actually occurred to refer to.”

Drug products are manufactured under strict quality requirements, especially biologics, according to Phillip Hernandez, head of Quality, Andelyn Biosciences; therefore, personnel working in these areas must be thoroughly trained in processes, gowning, the flow of the facility, aseptic techniques, contamination control, and documentation. “Improper training can lead to breaches in contamination control, introducing harmful microorganisms or particles into the drug product, which can have serious implications for patient safety. Proper training in documentation practices is crucial for maintaining compliance and traceability,” Hernandez stresses. “Manufacturing processes require precise execution of protocols and batch records. Variability in execution can result in batches that do not meet established quality standards, affecting efficacy and safety.”

Hernandez points to the example of a vaccine manufacturing facility that received an FDA Form 483 for multiple quality control deficiencies that resulted from poor training. “As a result of these findings, the company faced regulatory action and had to implement multiple corrective actions, including enhancing their training programs and reinforcing SOP [standard operating procedure] compliance among all personnel,” Hernandez warns. “This incident highlights the critical importance of effective training in ensuring product quality and regulatory compliance, particularly in high-stakes environments like vaccine manufacturing.”

While training is obviously not new in the pharma industry, Pinaud stresses that teaching the ‘how’ of an operation isn’t the only thing that matters. Personnel should also be taught the ‘why’ of what they are doing. “Training has been a focus for years now, so the actual execution of manufacturing is covered for the manufacturing operators. What we can tend to see is a focus on how to perform each operation and less of a focus on why each unit operation matters and what each step is accomplishing. Understanding the why is just as important as the how when taking a holistic approach to quality training,” he says.

Often, it’s the method of training that is lacking and/or how the training is conducted, according to Siegfried Schmitt, vice president, Technical at Parexel, often relying on great amounts of SOPs to be read and remembered. “If the training of the SOP were conducted in conjunction with performing the tasks, then this is much more efficient as visual experience is much better remembered than pure text, especially when unrelated to practical experience,” says Schmitt. “Training on the job beats mere theoretical training hands down.”

When training lapses or fails, it’s often up to training programs that have not been updated to include new technologies and changing regulatory expectations, according to Phillips. Management skills, especially, can be undervalued. “This area of training is critical, as poor management can lead to issues such as employee retention problems, insufficient follow-up on corrective actions, and decreased overall team performance,” says Phillips.

“I think the biggest area lacking training is around regulatory requirements,” says Silverman. “This area is particularly important because so much of the activities that occur at GMP facilities are a direct result of FDA requirements. Implementing such training is challenging because FDA regularly releases updated guidance documents and information; however, ensuring that staff are aware of regulatory topics can lead to smoother operations overall.”

Cucinella agrees that rapid advancements in technology are a challenge, with automation, artificial intelligence, and machine learning requiring continuous learning. In addition, Cucinella says, “With the increasing reliance on digital systems, ensuring data integrity and cybersecurity is paramount. Training on how to handle, store, and protect data is often lacking.”

“Pharmaceutical companies and contract manufacturers often lack robust and continuous training programs in GMP compliance and in the nuances of understanding analytical testing methods and interpreting data,” says Shailesh Vengurlekar, senior vice president Quality and Regulatory Affairs, LGM Pharma. “Personnel may lack training in data integrity and the importance of accurate and traceable data in manufacturing, especially with electronic record-keeping systems. Many contract manufacturers ignore the importance of instrument maintenance programs, which could lead to several product quality issues including contamination.”

Lee McKinley, director, Organizational Development, BioVectra (a part of Agilent) points to personnel not being able to fully observe processes and often not having full access to equipment for training. “Providing a safe environment for hands-on training, where employees can practice without disrupting ongoing operations, is crucial. Without this, ramp-up times can be significantly delayed, affecting overall efficiency and performance.”

How can training be conducted to ensure the quality of bio/pharmaceuticals? Moreton suggests the appointment of a ‘training officer’ who’s job and authority is to ensure proper training is taking place for both new and existing staff. “The training officer must also monitor the quality of training and keep records of attendees and also monitor individual training records. In the event of an error or incident that compromises quality, the training officer should be part of the investigation team,” says Moreton.

A comprehensive onboarding program that focuses on GMP training is essential, remarks Cucinella, as are detailed SOPs. Training for the role is also important, he says, to be sure the employee is trained on their specific roles and responsibilities. Creating a quality culture that fosters continuous improvement is also key, notes Cucinella.

Cyrill Kellerhals, COO at Andelyn Biosciences takes onboarding of personnel seriously by going “well above-and-beyond” when it comes to minimum requirements. The company also has a partnership with a university for new staff training and incorporates on-site training before a new operator begins. “[We also have] on the job training to ensure more experienced operators are working with new staff members while they build up their comfort level and ability to execute,” says Kellerhals.

After onboarding, Diem Hoang, director of Quality, LGM Pharma recommends that a training timeline be established to set training expectations going forward, then follow up with documentation to track the employee’s progress. Recertification should be scheduled if needed.

McKinley stresses that training should incorporate diverse learning styles and backgrounds, with clear lay-person language, in-person sessions, e-learning, hands-on practice, interactive elements, and feedback.

An electronic data management system (eDMS) should be implemented, according to Hernandez. “An effective eDMS provides up-to-date, dynamic reporting on the training records of every staff member and serves as a repository for the version history and current revisions of all SOPs and quality documentation,” he says.

The effectiveness of training should be measured with pre- and post-assessments, according to McKinley. Assessments enable one to identify where improvements in the training program are needed. “Additionally, incorporating refresher training later in the onboarding process helps reinforce key concepts. Repetition is vital to ensure that staff internalize GMP standards and consistently follow quality procedures. All of this contributes to a successful training program,” says McKinley.

Industry groups offer expert training. Utilizing industry groups is a tool bio/pharmaceutical companies can use to ensure a robust training program, specifically for GMPs, according to Phillips. These groups are usually knowledgeable of current regulations and often offer their own training programs that can be tailored to group members. “In addition, participating in these networks creates opportunities for knowledge sharing, adding insights to courses, and accessing further training resources,” says Phillips. “However, it’s equally important to have an effective mechanism for integrating this training into the organization. Often, employees attend external training sessions but fail to share their learnings with the broader team, which represents a missed opportunity for company-wide improvement. Establishing a system for disseminating and reinforcing acquired knowledge can enhance the overall impact of training,” he stresses.

“Such [professional] training can be used to augment any in-house training. They can also be used to audit company in-house training and overall training. In-house trainers must also be properly trained in training techniques and methods of instruction,” agrees Moreton. “Not everyone can train, but even good trainers can improve their effectiveness with proper training.”

With the global biologics market expected to reach US$1,374.51 billion by 2033 (4), it would suggest that this growth would create a demand for experience in the development and manufacture of these products. But how can bio/pharma companies and contract organizations keep up with the training their employees will need to meet this demand?

Moreton suggests that training in new modalities not be left to non-technical staff and that information available in the scientific literature be reviewed. “This can be achieved in several ways; one of the most effective is to engage the scientific and technical staff and ask them to review literature sources and add any noteworthy information to a central repository that is reviewed and discussed at regular meetings of the technical and scientific staff for relevance and importance,” he says.

“Maintaining effective training in the evolving field of biologics requires active engagement with industry groups and networking with other companies, as mentioned above,” says Phillips. “By staying connected to what is currently happening in the industry and understanding emerging standards, companies can continuously adapt their training programs to meet new challenges and requirements.”

The trainer also needs training to keep up with these new modalities, explains McKinley. “It is crucial to ensure that trainers possess the necessary expertise to effectively deliver training. This includes staying up to date on best practices by regularly participating in ‘train the trainer’ programs and professional development sessions,” he says. “These sessions should focus on emerging training technologies, innovative learning modalities, and adult learning principles, which are essential for adapting to the rapidly changing environment of biologics manufacturing.”

Quality in the bio/pharmaceutical is the responsibility of everyone involved in the development and manufacture of drugs. But if those individuals are not properly trained, mistakes can happen, resulting in either unsafe and/or ineffective drugs. Therefore, training should be an important part of a pharmaceutical company’s and/or contract organization’s procedures.

“While the quality department is ultimately responsible, it is critical for individuals in manufacturing, supply chain, and other functions to also understand what might impact quality, so that investigations can be initiated if concerns arise,” stresses Silverman. “Such inquiries can be especially important in highly complex drug products such cell and gene therapies, where the product characteristics can be hard to understand.”

FDA. Current Good Manufacturing Practice (CGMP) Regulations. 

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations (accessed, Nov. 1, 2024).

 https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice (accessed, Nov. 1, 2024).

. https://health.ec.europa.eu/medicinal-products/eudralex_en (accessed, Nov. 1, 2024).

Biologics Market Size, Share & Trends Analysis Report by Source (Microbial, Mammalian), By Product (MABs, Recombinant Proteins, Antisense & RNAi), By Disease Category, By Manufacturing, By Region, And Segment)—Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024–2033.

®
Vol. 48, No. 12
December 2024
Pages: 10–15

When referring to this article, please cite it has Haigney, S. Enhancing Quality Through Training. 

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.