A lookback on 20 years of pharma manufacturing

Oct. 10, 2022
A 20th anniversary celebration would not be complete without the voices of the sometimes unsung heroes of innovation — pharma solution providers.

A 20th anniversary celebration would not be complete without the voices of the sometimes unsung heroes of innovation — pharma solution providers. 

We asked prominent technology, equipment and services suppliers to take a trip down memory lane and share their thoughts on how the industry has evolved. Their answers shed light on the journey so far — and also gave us a peek at what is to come.   

Technology has shined 

“It's well understood that the pharma industry, historically slower than others to embrace next-gen digital technologies, has gradually come around in recent years. In the last decade, pharma manufacturers turned to digitalization to help improve the resiliency, flexibility and agility of their processes and supply chains. They’ve brought in top talent from adjacent industries to augment their in-house digital expertise. This influx of talent has left its mark, as companies embraced solutions like continuous manufacturing, closed-loop control, and predictive and prescriptive maintenance for optimizing plants and equipment.”  
Kelly Doering, Senior Director, Pharma Industry Marketing, AspenTech 

“The most prominent change over the past two decades is technology, which has broadened and bolstered what we are capable of doing and, in turn, what is expected of us. From our perspective as equipment solutions providers, everything from cams and mechanical systems to servomotors and robots has experienced varying degrees of enhancements or even revolutions. Advancements in cameras have occurred along parallel lines, allowing for new capabilities and tightened control over existing ones. All of this has meant more precise, more expedient production – and customer expectations have matured accordingly. We should be and are better than we were 20 years ago – a linear progress that makes lookbacks like this both satisfying and gratifying.” 
Deborah Smook, Vice President, Marketing & Business Development, TurboFil Packaging Machines   

“I think the two biggest hallmarks of the last 20 years have been innovation and globalization — both have spurred growth but had pitfalls. Innovation has grown at rates previously unheard of. For example: Cryogenic applications have led to expedited formulation development but have driven manufacturers and users to find higher-quality materials to meet the demands of this process. LED lighting has reduced power use and carbon footprints but required an overhaul of systems, lighting and training requirements. Advances in continuous manufacturing have greatly impacted supply but require equipment that can be inspected in the process to keep failures from affecting production. The same goes for globalization – it helped the world meet the crisis of a global pandemic in record time, but it has also caused producers to have to take into consideration global production requirements they never considered a generation ago. You can now work with customers and suppliers around the world but need to be able to meet standards and documentation requirements never previously planned. For 20 years, Pharma Manufacturing has helped this entire industry share ideas and adapt to these opportunities and challenges.”  
David Star, Chief Executive Officer, LJ Star  

“Over the past two decades, we have seen the industry continually strive to increase quality, which created the need for cleaner environments. As a result, we introduced fan-powered laminar flow HEPA filter diffusers to the pharma industry about 10 years ago, equipped with EC motors to provide constant airflow. More recently, manufacturers have taken air quality to the next level by employing sophisticated communication technology that allows them to connect, monitor and control a wide range of HVAC components. To keep up with this trend, we now offer native BACnet capabilities on all of our fan filter units, allowing them to link seamlessly to building automation systems.”
— Rob Haake, President, AJ Manufacturing

“Over the past 20 years, technology used to design and produce industrial electric motors has continued to evolve, offsetting production challenges. While reliability and safety continue to be priorities for most industries, equipment in pharmaceutical facilities has become heavily regulated and must meet a variety of laws and regulations that govern the patenting, testing, safety, and efficacy of the drugs they produce. Recent improvements in ABB’s stainless steel Baldor-Reliance motors have been made to meet the highest level of sanitary design. We have also seen increasing trends in long-term sustainability and energy goals, as well as movement toward predictive maintenance rather than reactive. ABB currently produces the world’s most highly efficient industrial electric motors, helping users reduce energy consumption and lifetime cost.  We also now provide condition monitoring of motor-driven systems, allowing manufacturers to predict failures before they occur, which has become a best practice to reduce unplanned downtime, create a predictive maintenance schedule, and ensure operations continue running.” 
— Matt Rodebush, Global Segment Manager for NEMA Motors, ABB 

 “There has been a generational change in R&D processes within the pharma industry in the past 20 years — with tremendous focus on bringing safer drugs to market faster by leveraging advanced technology. Technology has enabled every touchpoint in the R&D process to become tighter and more efficient, while keeping the safety of patients and the general population at the center of its mission like never before. Imagine the role of data and how it has introduced the ability to uncover patterns and achieve medical breakthroughs that simply would have taken exponentially longer (or been close to impossible) on pen and paper recordkeeping or even with first-generation software. We also have the transformation that has taken place thanks to the expansive potential of machine learning and artificial intelligence. Traditional pain points like disconnected studies, scattered findings, and siloed case reporting have become opportunities for organizations that are looking to embrace the momentum and drive medicine forward. At ArisGlobal, our customers do just that — safer and faster — with the innovative platform we have built, LifeSphere. It has been an exciting time for pharma R&D, and I look forward to the continued advancements that lie ahead in the future."
—  Aman Wasan, Chief Commercial Officer, ArisGlobal 

“From our position, over the past two decades, we’ve seen the advent and emergence of several dominant trends that have profoundly affected the pharma packaging space. First and foremost, increasingly complex drug formulations designed to combat difficult-to-treat diseases have required new ways of considering the relationship between a formulation and its packaging. More and more, packaging must deliver more value than primary or secondary protection. As drugs get more sophisticated, so must their packaging. We’ve seen the proliferation of more active packaging solutions that bridge gaps between a drug substance’s protection and stability needs on one end, and supply chain and shelf-life realities on the other. The ability to, for example, actively control the microclimate in the headspace of a package helps solve the challenges presented by increasingly complex and sensitive formulations, making them more viable, increasing their speed to market and broadening their availability. There’s also an environmental element to this. For example, we’re seeing active packaging solutions that prevent the sort of post-formulation degradation that otherwise would require wasteful and expensive overpackaging. But even more important is the preemptive interventions active packaging solutions can undertake, mitigating interactions at the compound level before they occur and destabilize the API. This heightened, even exacting level of product headspace control gives materials science a pivotal role from drug formulation through commercialization." 
— Badre Hammond, Vice President, Global Commercial Operations and GM, Aptar CSP Technologies 

The product mix has shifted 

The global biopharmaceutical portfolio today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise in treatments for many orphan diseases. These trends have given rise to biopharma products with extremely limited production runs, highly specific manufacturing requirements and genotype-specific products. This fundamental shift in the overall product mix and a focus on continuing to improve the efficiency and effectiveness of production is spurring an evolution in the technologies and processes needed to support advanced biopharma manufacturing. Innovation in manufacturing technology is helping to drive improved economics, flexibility and quality while potentially benefiting patients both directly and indirectly. The rise of advanced manufacturing technologies, modularization, closed system manufacturing, small footprint factory requirements and global-local manufacturing demand gave rise to the expansion of large firms to start manufacturing locally within many countries and many local grassroot companies came to life to manufacture and do business locally as well. These are positive benefits impacting societies by benefiting patients, the environment, and nation standing as a leader in innovation.” 
Robert Dream, Managing Director, HDR Company   

“In the past 20 years, our industry has changed significantly. The new drugs coming to market are becoming more and more complex, whether in conventional or new modalities. The time between discovery and launch is becoming even shorter, and innovation is increasingly driven by small and emerging companies. Lonza has been at the forefront of adapting service offerings to respond to these challenges through investment in both assets and ways of working, and by ensuring we deliver, on time, in full, and to quality, but also by providing a first-class customer experience.” 
— Christian Dowdeswell, Vice President, Head of Commercial Development, Small Molecules, Lonza  

“The COVID-19 pandemic highlighted the importance of aseptic manufacturing in the modern pharma ecosystem. Looking ahead to a post-pandemic landscape, demand for sterile processing won’t be abating any time soon. We will need COVID vaccine doses for under-served populations for the foreseeable future. And more biologics products than ever are entering the market, with 13 biologics being approved by the U.S. FDA in 2021 alone. Both require aseptic processing support. For contract manufacturers, the challenge will be to harness advanced sterile technology effectively to future-proof their infrastructure in order to deliver high-quality and efficient sterile processing and meet customers’ needs in the coming years.” 
— Ben Wylie, Head of Product Management and Marketing, ChargePoint

"As a silicone and TPE tubing manufacturer, NewAge Industries has seen exponential demand for its AdvantaPure high purity products over the past 20 years. The single-use market was growing prior to the COVID-19 pandemic and exploded once vaccine development and production was underway. As a privately-held, employee-owned company that is not part of a large conglomerate, NewAge is customer centric and has been able to quickly and efficiently shift from a just-in-time culture to one focused on just-in-case that foresees supply chain disruptions and other anomalies." 
— Sonia Schwantes, Director of Product Management, NewAge Industries 

The rise of risk-based approaches 

“As a CDMO with over 40 years of experience, one of the biggest changes our organization has seen over the last 20 years involves regulatory requirements in the development and manufacture of APIs. ICHQ7 regulations were the first set of defined expectations for drug substances. Since then, ICH guidance Q8, Q9, Q10 and Q11 have further detailed how our industry assesses risk surrounding quality and how we build quality into the API manufacturing process. The addition of QbD has provided a more enhanced understanding and control of the process while expanding knowledge of impurity origin, fate, and ultimately purge. The use of quality risk assessment tools for quantitating risk relative to controlling critical quality attributes have been instrumental in API processing development. Grace’s QbD and risk assessment approach continues to evolve with the emerging trends in the regulatory landscape allowing our customers to navigate the IND and NDA filings with success.” 
— Jim Springer, R&T Manager, Grace Fine Chemical Manufacturing Services  

 “The pharma manufacturing industry has begum the transition from a pure validation approach to today’s more widely accepted, risk-based approach. The shift to a focus on risk management, based on science and engineering knowledge, has changed the game for many pharma manufacturers. These companies struggled with the cost of validation and change management and the maintenance of legacy manufacturing systems. Operationally, decisions are fully based on science and engineering principles. Since 2006, pharma manufacturing companies have been prioritizing adopting the ICH standards Q8, Q9, and Q10, which provide increasingly up-to-date guidelines on quality risk management for developing and manufacturing a product. There is a widespread understanding that risk-based approaches provide significant savings in time to market and quality over traditional approaches. Our direct project experience at CAI confirms there can be clear results from execution effort and schedule when risk assessments are used.” 
— David Shenberger, Vice President of Consulting Services, CAI

The world is moving quicker  

“The field of pharma manufacturing has become increasingly sophisticated and specialized in the last 20 years, with new and innovative therapies being developed daily. It has become incumbent on architectural, engineering, construction and consulting firms like CRB to be partners that bring an exceptional level of knowledge and experience about life science processes to provide strategic guidance and advice to projects we touch. Technology and tools for communication and collaboration have reduced expected response times from days to minutes in every aspect of pharma manufacturing, with an emphasis on speed to market. Accelerated response times and instant collaboration on design changes put increased pressure on AEC firms to review, track and understand the impact of even the smallest decision. The migration to instant electronic communication has ironically led to more of a tendency for field contractors to ask more detailed questions because they can. The net result is the design specifications and plans need to have more detail to try to head off inefficient cycles on those information requests where we can. Especially in the past decade, companies are prioritizing operating efficiency and sustainability. AEC firms must look at every project from this perspective and constantly innovate to drive toward zero-carbon designs.” 
Bill Jarvis, Process Engineer, CRB    

Since KBI Biopharma’s founding in 2001, one of the most significant industry developments is the pace by which our biomanufacturing clients require access to technology, supply chain innovations, and partner expertise to meet their complex challenges. The rallying cry is now, ‘Better, faster, cheaper, streamlined.’ In this transformed landscape, manufacturers are bombarded with increased competition to respond quickly and efficiently while still being expected to offer a wider diversity of pharma modalities. As a CDMO aligned with the needs of our worldwide clients what that has meant for KBI’s own evolution is embracing that pace with proactive and curated solutions that ultimately contribute to the most beneficial patient outcomes.”
— Michael Landau, Chief Operating Officer, KBI Biopharma