Grant Playter

Last year was meant to be a transitory year for the bio/pharma industry. With vaccinations deploying in December 2020, there was hope among many of last year’s respondents to the 

Pharmaceutical Technology/BioPharm International 

annual employment survey that the overall state of the industry would bounce back in 2021. More than 75% of survey respondents expected the industry to improve, while 64.3% expected business at their employer to improve (1).

However, while most of the world has moved past the quarantine mandates that were commonplace at the onset of the COVID-19 pandemic, progress has been hampered by various unfortunate developments. These include highly transmissible variants, inequitable vaccine distribution, and a reluctance to receive a vaccine among large portions of the global population.

This year’s employment survey focused on the state of this transition. More than 300 respondents answered questions about the current state of their workplace, pandemic-related changes, and where they believe the industry will be headed in the future Refer to the 

Last year’s survey observed a dramatic decrease in many core metrics. In 2019, 55.4% of respondents received increased pay; this dropped to 41.7% in 2020. These lost numbers seemed to funnel into the “no changes” bucket, which rose from 33.2% to 44.8%. However, there was an increase in pay cuts, which rose from 11.4% to 13.7%.

The 2021 numbers have recovered to a state comparable to 2019. Approximately 53% of respondents reported a pay increase and 39.0% reported no salary changes, a difference of -2.3% and 5.8%, respectively. Interestingly, pay cuts hit a three-year low, with just 8.0% of respondents reporting a decrease in compensation

A similar trend can be observed in job security metrics. From 2019 to 2020, individuals who felt increased job security (relative to last year’s survey) decreased from 30.0% to 17.8%. Those who felt less secure slightly increased from 30.6% to 34.4%, while those feeling no change jumped from 39.4% to 47.8%.

In 2021, there were improved metrics across the board relative to both 2019 and 2020. Increased job security hit a three-year high of 30.4%, a slight increase on 2019, while those who felt decreased job security hit a deep new low of 17.00%. Those reporting no changes saw the biggest bump, with over half of respondents (52.6%) reporting that they felt no changes in job security.

While these trends are encouraging, it should be noted that one limitation of the survey is that these values are measured relatively, which necessitates additional context in their evaluation. For instance, if 2020 can be viewed as a down year, then returning to pre-pandemic levels of compensation/job security would inherently necessitate higher levels to compensate. If exact quantitative measures (for instance, a job security confidence scale) were implemented, we may receive further industry insights.

Pandemic-Related Workplace Changes May Be Here to Stay

Following the onset of the pandemic, bio/pharma companies began implementing new workplace measures and procedures in order to prioritize the safety of their workforce and mitigate the spread of COVID-19. In our 2020 survey, we asked respondents if their company had implemented any of the following procedures:

A. Changed work schedule to social distance on the job

D. Changed or reduced development program

E. Additional work hours on pandemic-related projects

This year, we asked respondents these same questions to measure what, if anything, had changed in widespread implementation of these practices.

Only four measures —C, A, F, and H—saw a decrease: 10.4%, 9.1 %, 4.7%, and 3.4%, respectively. Of these, measure H indicates no significant changes, which suggests more workers felt their company had implemented critical, pandemic-related changes to their workplace.

The overall headline of this data-set is implementation of work-from-home in bio/pharma workplaces. At the time of last year’s survey, a little over half (53.9%) of respondents stated that their company had implemented this measure. However, in this year’s survey, this number jumped to 70.5% of respondents.

While prior questions helped give a contemporary view of the pandemic’s impact, we also wanted to determine to what extent pandemic-related measures would remain in the long-term. This would allow us to not only get a sense of individual workplaces, but also provide commentary on the industry as a whole. In that vein, we asked respondents predictive questions about two of these processes: remote inspections and abbreviated approval pathways.

Remote inspections have emerged as an alternative to traditional on-site inspections, as they allow sites to maintain quality control compliance while also encouraging social distancing and accommodating workflow changes. When questioned to what degree these would occur once the COVID-19 pandemic “significantly subsided”, most respondents (62.4%) felt that they would continue at a higher-rate than before the pandemic. Conversely, just 26.6% felt that it would return to the previous model, while only 11% felt the current increase would continue.

The results were similar as it concerned abbreviated approval pathways. A majority of respondents (81.1%) felt that either “most” or “some” of these measures would continue to exist once the pandemic significantly subsides, while just 18.8% felt that they would completely/almost completely continue to exist or disappear.

To this point, the survey has supported the notion that the COVID-19 pandemic has, is, and will continue to impact the bio/pharma industry for the foreseeable future. However, various metrics that indicate a degree of economic recovery, such as job security and salary changes, can also be observed. It is perhaps because of this that we are seeing an increased degree of optimism among respondents.

 indicate, most respondents felt that their company (47.4%) and the bio/pharma industry (53.2%) exceeded their personal expectations in 2021. Additionally, the majority (58.4% and 60.5%, respectively) also felt that this upward trajectory of both would continue into 2022.

The precise future direction of the bio/pharma industry will be in question for as long the pandemic continues. However, as this year’s survey shows, the prevailing attitude is that this impact will not prevent future growth and development. Changes brought on by the pandemic would not have occurred without it, but that by no means equates to entirely
negatively impacts.

R. Peters, “Compensation Does Not Necessarily Align With Job Satisfaction,” 

Grant Playter is the Assistant Editor at Pharmaceutical Technology.

When referring to this article, please cite it as G. Playter, “The Long Path to Normal,” 

Articles

Survey respondents reflect on the state and future of the bio/pharma employment.

The Long Path to Normal

Bio/pharma is a fast-paced industry that is continuously innovating via new technologies and techniques. The determination of what, if anything, should be outsourced throughout the development, manufacturing, and commercialization process is subject to various interlocking factors that necessitate thoughtful consideration. What an outsourcing company can specifically offer over in-house offerings or cheaper competitors is crucial. Consequently, many outsourcing companies seek to adopt new technologies that can set them apart from competitors.

Small drug companies own a large portion of the overall drug candidate pipeline, but they typically require more assistance throughout the early process to successfully bring their drug to market. Inexperience in regulatory filings, trial design, and other early design elements can doom a drug before development.

According to Jeetendra Vaghjiani, senior director of clinical development and strategic marketing at Lonza, emerging biotech companies are reliant on CDMOs because of their development and manufacturing capacity, expertise, and flexibility. These can prove pivotal in successfully bringing candidates to clinical trial, placing increased importance on end-to-end CDMO services (1).

In a similar vein, companies that can provide drug discovery solutions for these same, inexperienced start-ups looking to advance their product are also attractive. As companies enter the bio/pharma industry, CDMOs that can demonstrate repeated success in finding promising candidates will continue to get hired.

Armin Spura, CEO of Crown Bioscience, stated that a major advantage of outsourcing drug discovery is access to specialized technology and expertise. Because of the high attrition rate associated with drug development, the better your preclinical program, the stronger the position you can establish in terms of program design and patient identification (2). If one can improve their preclinical process with a CDMO, they will ultimately improve their chances of approval.

In recent months, biosimilar production has seen a boon in development. Following the Biologics Price Competition and Innovation Act in 2010, FDA had approved just 30 biosimilars through 2020 (3). However, FDA announced the approval of the first interchangeable biosimilar insulin product, Mylan Pharmaceuticals’ Semgle (insulin glargine-yfgn), in July 2021.

Since then, FDA has approved multiple biosimilars, such as Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) for Humira (4) and Samsung Bioepis’ Byooviz (ranibizumab-nuna) for Lucentis (5). This situation presents a unique opportunity for the commercial viability of interchangeable biosimilars. However, because of the relative scarcity of approvals over the past decade, companies looking to capitalize on this new market are likely to require specialized knowledge to get through the approvals process. Kelli Phillips, associate director of ImmunoChemistry at PPI Laboratories, noted that because contract research organizations routinely support biosimilar product submissions to regulatory agencies, they understand the current best practices expected by said agencies. (6).

Messenger RNA (mRNA)-based therapies took center stage following the release of the Pfizer-BioNTech and Moderna COVID-19 vaccines. The development of these vaccines was built on over 50 years of foundational research into mRNA (7), but it is only after the release of mRNA vaccines that we have seen this rapid expansion in demand.

Moderna outsourced some production of its COVID-19 vaccine to CDMOs like Lonza, one of the world’s largest pharmaceutical services companies. Shortly thereafter, demonstrating one’s ability to provide some form of mRNA service became a hot commodity. In the past six months alone, large CDMOs, such as Samsung Biologics and Lonza, have advertised massive expansions of their mRNA manufacturing capabilities, which has been mimicked by various smaller companies scrambling to keep up (8, 9, 10).

The race to receive lucrative partnerships is on. While the industry is still in the infancy of this boom, as mRNA capabilities become a utility tool in drug development, CDMOs will attempt to present themselves as the best option for development and manufacturing.

1. C. Challener, “Trends in Outsourcing of Bioprocess Development” 

2. F. Mirasol, “Biopharma Industry is Seeing Merit in Early Preclinical Strategies,” 

3. J. Wechsler, “Biosimilars Move to Center Stage,” 

4. PharmTech, “FDA Approves Cyltezo as Interchangeable Biosimilar with Humira.” 

5. PharmTech, “FDA Approves Biosimilar for Treatment of Eye Disease.” 

6. F. Mirasol, “Bioanalytical Studies Support Biosimilars Approval Pathway,” 

7. C. Beyrer, “The Long History of mRNA Vaccines,” publichealth.jhu.edu, Oct. 6, 2021.

8. PharmTech, “AGC Bio Boosts Manufacturing Capacity for pDNA and mRNA at Heidelberg Facility,” 

9. BioCina, “BioCina officially opens full-service CDMO in Adelaide, Australia, including mRNA and pDNA cGMP manufacturing,” 

10. Arcturus, “Arcturus Therapeutics Collaborates with Vingroup to Establish Manufacturing Facility in Vietnam for Arcturus’ Investigational mRNA Vaccines for COVID-19,” 

Grant Playter is the Assistant Editor at 

When referring to this article, please cite it as G. Playter, “Outsourcing's Race Toward Novelty” 

Recent developments in the outsourcing industry include a focus on early development services, biosimilar production, and RNA technology.

Outsourcing’s Race Toward Novelty

The supply chain disruptions brought on by the COVID-19 pandemic resulted in significant changes to workplace operations. In the context of aseptic production, the impact on ongoing operations is certainly present, but it can be more clearly felt in the trends beginning to take shape in advance of the European Union’s upcoming changes to Annex 1 regulatory guidelines. These changes, which are largely concerned with overhauls to contamination control strategy and procedures, are poised to enforce changes in the European aseptic manufacturing landscape.

Patrick Nieuwenhuizen, director senior consultant at PharmaLex, notes that in aseptic production, existing contamination control procedures were already in line with the types of measures that were being enacted on a global scale following the onset of the pandemic. Instead, changes in aseptic production workflow were more along the lines of finding ways to get staff that needed to be in the building (e.g., manufacturing personnel, quality control lab technicians, cleaners) present and performing their tasks in a safe and socially distanced manner.

According to Philip Vanek, chief technology officer at Gamma Biosciences, a life sciences tools company backed by private equity firm KKR, the biopharmaceutical manufacturing industry continued to face significant added pressure to consistently meet quality measures. Adhering to good manufacturing practices (GMPs) already significantly limits the ways a company can operate; throwing a pandemic in on top of that necessitates creative thinking as a means of navigating these supply chain disruptions.

“Necessity is the mother of invention,” says Vanek. “Most established equipment manufacturers scrambled to meet demand in the already stressed supply chain. One change that we did observe early on was an increasing expression of interest and demand of equipment and single-use consumables from smaller, lesser known brands that could substitute in the manufacturing workflow [as a replacement for those that were in short supply].”

The short supply of some consumable single-use parts led some to consider stainless-steel alternatives that allow them to rely on in-house procedures rather than continual shipments from an outside supplier. Properly maintained stainless-steel systems can last upwards of 20 or even 30 years without needing a full replacement, adds Nieuwenhuizen.

With single-use-systems, however, the need to clean systems between cycles is eliminated, saving time and money on validation and revalidation procedures. Richard Denk, senior consultant, Aseptic Processing and Containment at SKAN, believes that validation concerns are absolutely front of mind for manufacturers.

“The word ‘validation’ will have a big impact on equipment design and cleaning procedures in the future, as current designs are often not easy to clean and for that reason need to demonstrate a robust validation,” says Denk. “If we look at the pipeline in the future, many new products in development are considered highly potent. [At the same time,] inappropriate cleaning procedures are the most common findings during GMP inspections in shared facilities.”

Single-use systems are just one way companies are attempting to ease the load of maintaining GMP requirements with a compromised workforce. The industry was always going to need to engage in some level of introspection into common methods and practices in advance of upcoming changes to Annex 1.

Following several drafts and comments from various pharmaceutical companies and organizations, the EU’s changes to Annex 1 are set to have a pronounced emphasis on contamination control strategies. Notably, the revised guidelines contain detailed instructions on isolators and restricted access barrier system (RABS) technologies and new sections on form-fill-and-seal systems and single-use systems.

“For the company to demonstrate they have a good understanding about their processes and what risks and controls they have in place was often sufficient to have a validated process,” says Nieuwenhuizen. “Now it becomes more important to provide justification and evidence why the process you have designed as a company and the controls you have implemented are adequate to assure that you have an aseptic or sterile product.”

It is because of this increased scrutiny on holistic process development that companies have begun fine tuning their contamination control strategies. There are various ways to factor optimal contamination control into one’s aseptic production process, says Denk, who was the GMP lead for the development of the SKAN-Groninger robotic filling line. Denk’s line was fully automated, including measures that help in contamination control such as viable monitoring and automatic delivery of indirect product contact parts.

According to Vanek, companies have invested in technologies that de-risk manufacturing, including process analytical technologies and continuous closed manufacturing. “Technologies that improve production efficiency in terms of classified space utilization, such as automation enabled by new process analytics and high-efficiency closed continuous production systems, have been in the spotlight. The momentum towards single-use manufacturing in aseptic processing, both upstream and downstream, is likely to continue and perhaps accelerate with the adoption of new process analytical technologies and the data sciences that support them.”

The upcoming revision to Annex 1 has incentivized manufacturers to do everything in their power to minimize direct contact of product by operators. With this context in mind, the trend toward single-use-systems, automation, and other strategies to close systems and minimize contamination is not likely to go away even after the
pandemic has fully passed.


Volume 45, Number 12
December 2021
Page: 10

When referring to this article, please cite it as G. Playter, “Looking Past the Pandemic: The Future of GMPs in Aseptic Processing,” 

While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.

Looking Past the Pandemic: The Future of GMPs in Aseptic Processing

Laks Pernenkil, a partner for Deloitte’s life sciences consulting business, discusses various findings from Deloitte’s research into the biopharma industry with Grant Playter, associate editor. Topics of discussion include Deloitte’s recent report on the state of biopharma, broader digitalization trends, how generative AI will affect pharma going forward, the push toward supply chain resilience, and more.

Videos

Laks Pernenkil, a partner for Deloitte’s life sciences consulting business, discusses various findings from Deloitte’s research into the biopharma industry.