Powder Transfer for Biotech

By: Lonna Gordon
Process Engineering
IPS- Integrated Project Services, LLC

Solids transfer is typically considered a problem reserved for the oral-solid dosage (OSD) community, where the powder is the main product bulk; however, it comes up with reasonable frequency in the biotechnology world as well. Applications range from adding salts to a sterile media tank, dry media preparation, pH adjustment after filtration processes, as well as addition of precipitation salts to a tank. This article will survey the basics of closed powder transfer for the biotech professional.

The primary assumption we will make is that the powder or salt is pre-weighed and measured into a powder transfer container. If the solids must be metered into the process, this level of complexity is beyond the scope of this piece.  The second assumption is that closed-transfer is desired for protection of the product. Our third assumption is that powder quantities are too large to use a single-use bag and manual lifting as the transfer method. Larger quantities will be moved through the facility in drums or Intermediate Bulk Carrier, and demand more specialized equipment for successful transfer into the processing vessel.

In order to ensure that the transfer is fully enclosed, the primary connection between the powder-supply container and the receiving process vessel will be through an SIP capable split-butterfly valve (SBV). Most commonly used for powder transfer applications in OSD facilities, this specialized valve allows two separate vessels to create a clean, closed transfer connection. However, there are only a few SBVs that can be equipped with a sprayball. This a detail to consider when selecting a valve.

There are two ways to transfer the powder from the container to the vessel: gravity feed and vacuum transfer. Gravity feed involves positioning the entire container above the vessel, opening the connection between them, and allowing the solids to pour down into the vessel. With vacuum transfer, the drums or IBC can be located at any level relative to the tank. The powder is moved via negative pressure to a receiver mounted on the vessel, where it is then dropped into the vessel through the connecting valve.

Both options allow for the powder container to be located either in the processing suite with the vessel or in a separate room.

Gravity Feed – In-Room Transfer

A hoist is used to lift the drum or IBC above the tank and slew or invert it into position. It mates with the SBV. The hoist can be permanently fixed in the room, or it can be a mobile unit that carries the drum into the room and is stored elsewhere at all other times.  The elevation available in the room is the limiting factor when using this method.

Gravity Feed – Second-Floor or Mezzanine Transfer:

The drum or IBC can also be lifted to a second floor or mezzanine using an elevator and docked to a transfer chute that connects to the vessel below. If a completely separate second-story space is used for docking, it can be a lower classification than the vessel’s processing suite. This is due to the connection to the chute will be totally enclosed, and there will be no contact between the contents of the IBC and the surrounding environment. There are some cleaning considerations for the chute; it will require a sprayball cap to wash it in place before removal for cleaning. Additionally, there must be space available for utilization on multiple floors.

Vacuum Transfer:

Vacuum transfer can occur from almost any space adjacent to the receiving vessel – the same room, the next room, the floor above, or the floor below. For IBCs, an adapter on the outlet of the IBC allows the powder to be pulled through a transfer hose to a receiver at the top of the tank. The transfer is completely enclosed and therefore, the IBC can be stationed in a room of any classification.

Drums, on the other hand, typically require an operator to manipulate a wand in the drum to ensure full powder transfer. This process is not completely enclosed and should take place in a space with a classification that matches that of the receiving vessel. There may be some fully closed, more customized options available for drums as well.

2018’s Leading Industry Challenges: Tomorrow’s Biggest Opportunities?

By Meg Snyder, Attendee Acquisition Manager – INTERPHEX, Reed Exhibitions

Whether you work in pharma, biopharma, biotech, or any other sector of the industry, one trend is clear—change. The industry continues to learn and grow, pursuing better, improved, and more sustainable solutions.

Consolidation Reigns Supreme

In 2018, consolidation continues to maintain prominence in the outsourcing space, according to Mark Quick, Executive Vice President – Corporate Development, Recipharm. “The largest CDMOs hold just 2-4 percent of the market and the top ten CMOs represent less than 30 percent,” he added. “With many consolidation opportunities still available, buying expertise remains an attractive prospect for a CDMO with sufficient financial resources.”

Although consolidation as a trend isn’t new to the industry, it’s seeing continued growth as companies are “realizing the time, cost, and efficiency benefits of reducing the number of outsourcing partners they engage with and accessing a full-service offering,” Quick explained.

“Weak players will slowly leave the market, creating supply issues for their customers who will need to find a reliable CDMO partner to ensure continuous business,” Quick continued. “We also expect demand for contract manufacturing to increase as drugs become more complex and pharma businesses look to reduce their in-house costs and resources.”

As a CDMO with a global presence, Recipharm has also experienced the rippling waves of serialization initiatives on multiple shores.

“Clearly, serialization is also a major industry development that is set to shape the sector over the coming months,” Quick said. “Contract manufacturers are facing the introduction of the European Falsified Medicines Directive (FMD) in February 2019 and are at different stages of their preparations. Those that fail to prepare risk loss of business, as they will no longer be able to supply products to this important market. We anticipate that pharmaceutical companies will increasingly make their outsourcing decisions based on whether their CMO has the necessary capabilities to comply with the FMD.”

According to Quick, Recipharm expects that more than 80 percent of the company’s production will require serialization. As a result, they are implementing new systems and processes across around 75 production lines. However, with the CDMO’s proactive approach to implementing a solution, including a dedicated taskforce and a serialization program in place, they are well on their way to being in compliance on a global scale.

Meanwhile, the next deadline for the Drug Supply Chain Security Act (DSCSA) in the US is November 27, 2018, where repackagers must have serialized product. In addition, due to the FDA’s extended deadline, manufacturers will also have to have serialized product by November of this year.

Rise in Manufacturing Demands

In addition to consolidation, the demand for the manufacture of highly-potent active pharmaceutical ingredients (HPAPIs) has seen an influx, said Chris Rombach, President, ChargePoint Technology Inc., which has been fueled by the growth of the biotech and oncology markets.

“As these markets flourish, huge implications have been felt throughout the supply chain, particularly by manufacturers,” Rombach continued. “In addition, we continue to see the diversification of the companies we serve.  Companies are increasingly operating on a global scale and are wanting to coordinate across different sites.”

With so many companies operating across multiple sites and outsourcing services, standardizing and organizing internal processes has become even more important.

“[T]here is a rise in ‘virtual’ companies that rely on outsourcing, collaborations, and contract manufacturing for their production,” said Rombach. “The result of this is there are increasing numbers of stakeholders and decision-makers involved in the projects and therefore being able to bring everything together is more complex today than in the past.”

Although the boom in biotech has been an ongoing industry trend, the containment sector is “expected to continue this rapid growth alongside it,” Rombach said, adding that 2018 appears to be a turning point.

“Finding the best containment strategy has always been important for high potency manufacturers, with operator safety and product quality at the forefront of their priorities,” said Rombach. “However, the growing need for advanced control strategies to improve efficiencies and handle ever-more complex products has led to the adoption of more innovative solutions.”

Increasing Output

According to Parrish Galliher, Chief Technology Officer – Upstream, Bioprocess, GE Healthcare Life Sciences, there have been a number of continued trends in 2018:

1. Single-use, upstream continuous perfusion systems and continuous DSP
2. High speed, at-line, on-the-floor QC assays for real-time release
3. Commercial licensure of additional SU facilities (now at four worldwide)
4. High productivity/output biomanufacturing

“[N]othing happens rapidly in this industry. It gets tested in the lab first and then takes years to be used in clinical manufacturing and eventually validated for commercial manufacturing,” Galliher said. “The exception is upstream continuous perfusion—this is an old technique used by 19 commercial biologics on the market.”

There have, however, been new trends developing over the past three years, Galliher added. There has been a rapid growth of SU manufacturing in non-US and non-EU territories. In addition, optimizing brioprocess, process understanding, and digital information support has also taken a turn due to digital technology and IoT (the Internet of Things).

Biologics & Biosimilars See a Global Boom

HighTech Business Decisions – Biopharmaceutical Contract Manufacturing states that “the biologics market is expected to grow by 7-9 percent by 2022 and is projected to reach $3.8bn,” Quick said.

Biosimilars entered the US market for the first time in 2015 with US FDA’s approval of Sandoz’s Zarxio (the biosimilar to Amgen’s Neupogen [filgrastim]).

In 2015, the US FDA approved one biosimilar. That number increased to three in 2016 and then to five approved biosimilars in 2017.

More biosimilars have been approved each year in not just the US, but around the world, Galliher added.

“The technically-challenging nature of biologic drug development and manufacturing will certainly help to fuel the outsourcing sector,” said Quick. “Demand for outsourced services is growing in areas, including lyophilization and sterile liquid fill and finish operations, as each requires significant investments and expertise.”

Addressing Industry Challenges

“Rising prices across the globe will always add an element of pressure to our industry,” said Rombach.

But price tags on treatments aren’t the only challenge facing the industry today.

According to Galliher, “hiring enough talent to keep up with growth rates” continues to be a challenge for the industry as a whole, along with “developing technology and expertise to support the development and manufacturing of new drug modalities” and “expanding and enhancing our supply chain to enable digital and IoT capabilities for biopharma.”

For 39 years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event, taking place in New York and bringing more than 10,500 global industry professionals and 650+ suppliers from across the industry.

By bringing together thousands of industry professionals, assisting in the facilitation of the launches of new technologies, products, and services at the show, and providing opportunities for industry experts to share knowledge, INTERPHEX has assisted the industry in tackling these challenges head-on for nearly four decades.

“As always, we are very much looking forward to meeting with our industry peers to talk about the current industry trends and focus,” said Rombach. “The Technical Conference sessions are always a highlight for us and we are looking forward to seeing advancements being made across the industry.”

Register today and join thousands of industry professionals at the Javits Center in New York City on April 17-19, 2018!

Manufacturing Facilities: Delivering the Right Tool

By: Erich Bozenhardt
Process Manager
IPS-Integrated Project Services, LLC

Every project manager can tell you that there are only three project drivers: schedule, cost, and quality. We see these factors in every day in tasks we do, and in everything we purchase. The operating companies are also under the same pressure on the delivery of their products: get treatments to patients faster, lower the cost, and answering the question: why can’t our medicine be defect or side effect free.  As an industry, we are answering with a deeper understanding of the science of medicine and better tools to deliver medicine. A manufacturing facility, its technology, compliance, flexibility, and the capabilities are the enabling tools for production.

We need to design before we build

In every application of pharmaceutical technology a design of what we are to build is necessary to provide specifications of construction, construction methodology a fidelity of design and technology (i.e. fit for use), compliance to FDA and EU regulations, and a basis for commissioning and validation.

Our industry uses the following methods and delivery tools:

• Conceptual Design – This 1 percent of the total facility cost is the key to all designs. This provides the agreement of how we translate the technology into a constructed entity. This level of design provides the process, architectural, HVAC, utility, and facility bases. Typically, depending on the technology, greater depth is provided in the unique technology area.
• Preliminary Engineering – This engineering stage takes the conceptual design and creates functional documents for each aspect. This stage of engineering can be attenuated if the process technology can be configured from vendor equipment and if the facility can be built with a “building block” concept.
• Detailed Design – This design stage provides detailed drawings and construction instructions. This level is required on each design discipline if and only if it is being built from scratch.

Clearly, “buy” not “build” can accelerate the design phase

Building Trade-Offs?

• Schedule

-Minor renovations might be quicker with gypsum board, but particles and an affinity for mold put that construction material at risk and reduces quality.

-Modular wall systems are quick within an existing space and don’t lose speed with scale, walkable ceilings allow more parallel construction activities, and eliminate the need for detailed design.

-Modular pre-built clean rooms and support systems are the quickest for large scopes

• Cost

While in some lower cost labor markets the use of gypsum board and on-site assembled AHUs may appear to be lower in costs, the adjustments, designs and commissioning exercises add to the costs. Secondly, the labor markets within the biotech business have been increasing and the labor advantage over modular has nearly disappeared.

• Quality

-modular panels provided a robust easily cleaned solution and a long-term quality finish

– Pre-configured and pretested AHUs in modular systems provide a unique opportunity for precision and reduce installation/balancing/commissioning time.

How to Build?

Design/Bid/Build is the traditional method of building in the US. A firm is contracted to produce a design then the design is bid and a different firm is selected to build. This method is believed to yield the lowest price and philosophy of enforcing checks and balances.

The more modern Design/Build finds synergy of firms that offer design and construction management to reduce cost and schedule. From a contracting standpoint, it provides simplicity and clarity to owners as there is one responsible party for the whole project.

Design/Assist is a method where the designing firm lays the groundwork and then engages the contractors who will be executing the work to provide assistance in completing the design. This method allows the contractors to provide input into the design to facilitate installation and prevent iterations on construction documents yielding a lower cost and quicker schedule. The general consensus is by having a constructability focus to the design the project can be done for less time and money without comprising quality.

So Where Does This Leave Us With Finding The Right Balance?

For small-scale renovations, it makes sense to match existing materials but caution is required for the HVAC system and its extension. Many of these smaller projects can benefit from a Design/Build approach.

For larger scopes of renovation, modular panels allow for reasonable construction schedules and the flexibility to work with spaces of existing complex geometry. For new projects and major renovations that work within a large shell space, modular clean rooms and modular systems can provide both schedule and cost reduction due to the total reduction of labor time in the field (balanced via off-site fabrication).

Some vendors have taken modularization to the next level with pre-engineered solutions that incorporate process equipment based on common process platforms to further reduce cost and schedule.

There is a place in the industry for various delivery methods and the key is matching the method to your project.

Leapfrog – an Opportunity for Sterile Product Manufacturers with Aging Facilities to Reduce Risk and Become More Profitable

By: Paul Valerio
Director of Technology
IPS-Integrated Project Services, LLC

Aging facilities in pharmaceutical manufacturing are a topic of much concerned discussion in the industry and in world healthcare circles, especially where sterile products are produced. Facility conditions and obsolete technologies pose risks to product quality and, therefore, supply of medicines to patients. Facility finishes, aging water systems, manual cleaning methods, and presence of gowned personnel in the aseptic environment performing open process manipulations all contribute to process risks.

Deteriorating and dated systems are not the only factors working against aging facilities. The world outside those old walls is changing and moving forward. New knowledge and advances in process technology and facility design have improved greatly in the industry compared to the basis against which older facilities were designed. These advances then raise the bar for regulators’ expectation of quality. They observe older construction methods being replaced with sealed modular wall systems that are more cleanable and less susceptible to environmental risks such as mold. Automation of processes is taking over manual steps in areas such as cleaning of vessels and parts, bio-decontamination of equipment, and automated loading of freeze dryers. Operations with fully gowned personnel performing aseptic manipulations adjacent to open sterile product in traditional Grade A clean rooms are replaced with those utilizing barrier systems. Isolator systems, in particular, are becoming simpler and more compact. Regulators expecting these advances in newer facilities organically raises the pressure on manufacturers operating aging facilities to replace or upgrade.

The improvements mentioned above for facility and process design represent advances in protecting sterile products, and they are good for business from a compliance standpoint. Advances in process technology also present opportunities for better profitability due to increased capability. New systems offer higher throughput and product yield through features like 100% in-process checking (IPC) and advanced dosing to utilize every drop of bulk product. Market trends toward specialized products have inspired creation of a new range of technologies capable of providing flexibility to fill numerous components in one suite, including vials, syringes and cartridges.

A compliant facility design coupled with advanced process technology creates capability to run efficiently with fewer process risks and deviations. That’s good business.

So, what does all this serious stuff have to do with Leapfrog? One form of “leapfrogging” in business is to profoundly advance in capability by taking advantage of progress already made by others. In recent years, impressive progress has been made in robust fill-finish process technologies in terms of performance and compactness. The ratio of opportunity to risk is more favorable than ever for manufacturers looking to progress their aging sterile product facility. Robust systems are available to enable just about any product portfolio, offering new business opportunities and multiple paths to return on investment.

Opportunity awaits, yet it is not so simple to seize it. Many organizations are so focused on making their older facilities function well that there is little time to keep up with current technology. Once organizations decide to pursue upgrade or replacement of aging sterile product facilities, simply transferring old processes to new equipment might provide just a fraction of the potential gain. Perhaps the greatest challenge in looking outside those old walls is grasping what new technologies are available and how to apply them. Creating the most successful future possible involves product portfolio strategy and research in several areas, one of them being currently available and emerging process technologies. Internal research and leveraging support from qualified process solution providers and design firms will help lead to a much needed leap ahead.

Focus on Process

By: John Lyons
Sr. Process Engineer
IPS-Integrated Project Services, LLC

Human nature draws us to things that are shiny and new; it’s a tendency that crosses all geographical and cultural boundaries. There are departments, businesses and in fact entire industries whose primary purpose is to leverage this tendency into sales and profit. These forces are active on us whether we are aware of it or not throughout most aspects of our personal and professional lives. When starting a new project what comes to mind first? What are the juicy bits everyone wants to jump into – Site Planning, Equipment Selection, Color Pallets, and Architectural Details? While those of us trained to operate within a regulated industry may be slightly more aware of these internal and external forces acting upon us, or at least the unbalanced focus on the end product, we are far from immune. How do we resist the temptation to shortcut thorough evaluation and jump straight to pre-conceived solutions? Simple – Focus on the Process.

Focusing on the process can lead to improvements in a number of aspects of life; in terms of life sciences, from inception to full scale commercial operation it’s a keystone to success. Unfortunately though, “the process” is essentially intangible compared to other shiny bits and pieces that come together for a successful project. As a result, it can take a back seat or not be considered altogether until it’s too late. It is, however, the process definition that brings together man and material into a well-structured and smooth flowing operation. Compromise it and you’ll be suffering the work-around for years to come.

In practical and simplified terms a project would follow a basic hierarchy of: Process => Equipment => Facility => SOPs (standard operating procedures). The Process drives equipment selection. The facility provides appropriate space for the process and equipment. Finally the SOPs provide guidance to personnel on how to interact with the Process, Equipment and Facility to deliver the desired end product. SOPs are most easily followed and managed when they are primarily serve to bring together previously defined and designed steps and processes.

Putting the cart before the horse: Difficulties arise when the facility or equipment are not designed for the process and work-arounds are required. This expands the detail and often technique required to follow SOPs increasing rigor and strain to operators, ultimately reducing robustness of the operation. In a worst case scenario, work-arounds are not sufficient and equipment or facility replacement or modifications are required.

A “Process First” mindset is not always the easiest approach, but it will go a long way in providing a consistent frame of reference for decision making and ensuring you arrive at the destination you envisioned the start of your journey.

NJM Introduces Dara SX-310-RDL Aseptic Machine for Vials

NJM Simplifies Packaging with the New Dara SX-310-RDL

At NJM, we believe in the power of innovation. Our agile engineering philosophy and modular designs allow us to quickly offer machines to accommodate new component technologies. Not long after RayDyLyo caps first hit the market, we are able to give our customers a new aseptic filling and closing machine, based on the existing SX-310 system, that seals vials with these unique caps. Meet the new Dara SX-310-RDL.

Dara SX-310-RDL

To be on display for the first time at INTERPHEX in NYC, the compact Dara SX-310-RDL eliminates the crimping required with traditional aluminum caps to simplify the packaging operation and speed throughput, while offering fast and easy changeovers and new container size setups in the future. It’s ideal for 503B pharmacies and biotech manufacturers filling solutions, suspensions, diagnostics, vaccines or cellular tissue The Dara SX-310-RDL seals vials by using simple vertical pressure on ARaymondlife’s patented RayDyLyo caps, pre-assembled plastic closures that feature a rubber stopper within the cap. Compared to aluminum closures, RayDyLyo caps minimize the ‘pop-off’ effect and reduce the risk of rubber stoppers adhering to freeze dryer plates. By eliminating the crimping station, the Dara SX-310-RDL offers a smaller footprint, lower maintenance and less particulate generation compared with traditional filling, stoppering and capping systems.

Dara SX-310-RDL CU

Learn more about the Dara SX-310-RDL in our press release. As a trusted single-source provider of automated packaging systems, we offer a variety of solutions to pharmaceutical and nutraceutical manufacturers including tablet counters, labelers, serialization solutions and more.

Speak with our team at INTERPHEX 2018 Booth #2353 or reach out via email at: info@NJMPackaging.com.

MilliporeSigma @ INTERPHEX 2018

Mobius® Power MIX Single-use Mixers- Increase Your Capacity, Not Your Footprint

The Mobius® Power MIX family of single-use mixers combines high performance mixing technology with design features that make it easy to use. Extended sizes (2500 and 3000L) will be introduced at Interphex in April 2018. All  sizes (100L up to 3000L) include our proven impeller design and motor based on NovAseptic® magnetically coupled mixing technology. Every model efficiently mixes the most challenging buffers, media and biopharmaceutical ingredients. Our newly extended sizes can increase your capacity without increasing your footprint.

Visit MilliporeSigma at INTERPHEX in Booth #2841!
Learn more: www.Emdmillipore.com/powermix

SP Scientific @ INTERPHEX 2018

SP Scientific Pilot to Production – Range of standard & custom freeze dryers, autoloading systems & process skids produces Freeze Dryer Innovation & Excellence. SP is one of the most technically innovative freeze drying manufacturers with a focus on understanding the needs of researchers and dedicated to providing quality equipment with superior application and technical support. Our brands provide complete project support from design specifications through engineering, fabrication, GAMP 5 documentation packages, installation, service and parts, as well as world-class vial handling solutions.

Visit SP Scientific in Booth #2523!

Learn more about SP Scientific: https://www.spscientific.com

Finding New Roads

Customer demands are shifting fast, and new designs are helping manufacturers navigate the market apex

By Karen Langhauser, Chief Content Director, Pharmaceutical Manufacturing

Just in time for its 115-year anniversary, Harley-Davidson unveiled what the iconic motorcycle manufacturer is touting as its largest ever product development project – eight redesigned cruisers and five new touring bikes for 2018.

But it’s not just about celebrating its 115th anniversary; Harley-Davidson is losing market share and watching its baby-boomer customer base age out of riding.

Intensive customer research has revealed that a large part of the problem has to do with design. Essentially, next-generation riders want bikes with more sophisticated packaging.

As you will read in Pharmaceutical Manufacturing’s packaging issue (https://info.pharmamanufacturing.com/2017-september-pharma-manufacturing-digital-issue) , the drug industry can identify with Harley-Davidson’s struggles. The rising popularity of new biological drug formulations is creating unique packaging challenges and equipment demands. Due to the complex nature of these next-generation (mostly liquid injectable) drugs, they are particularly sensitive to leachables. According to industry expert Jerry Martin (https://www.pharmamanufacturing.com/articles/2017/state-of-packaging-in-the-pharma-industry/), each biosimilar will require different precautions and react with packaging differently.

Our recent product focus discussion (https://www.pharmamanufacturing.com/articles/2017/product-focus-packaging-systems/) found that packaging equipment suppliers are designing equipment to meet the specific needs prioritized by the modern-day pharmaceutical industry. Many new biologics are in the form of targeted therapies and personalized medicines, thus driving drug manufacturers to produce treatments more efficiently and in smaller quantities. These new roads demand a more flexible, scalable approach to meeting the industry’s packaging needs.

In the drug industry, this move toward smaller, more responsive production lines is causing an increased need for contract packaging organizations. These contract packagers are tasked with a challenge similar to the one Harley-Davidson is facing: drug manufacturers are looking for more design innovation in packaging – and they are relying on contract packagers to provide it. And as you can read in a recent Pharmaceutical Manufacturing cover story (https://www.pharmamanufacturing.com/articles/2017/leaders-of-the-pack/), contract packagers are hammering down.

Harley-Davidson, too, appears to have delivered, by coming up with a new line of bikes that maintain the classic Harley feel but on a lighter, more powerful, more high-tech frame. Harley says all eight of the 2018 cruisers offer quicker acceleration, better braking and handling than previous models. The new cruisers are even sporting modern features like LED, USB ports, digital instrument screens and keyless ignition.

Not surprisingly, agility is key. Harley-Davidson’s new bikes will enable a next-generation of riders to steer and corner more easily, and new drug packaging will enable drug manufacturers to navigate the twists and turns of modern pharma market demands. New paths have been paved, and for both industries, the adventure continues.

That’s a Wrap

Penetrating the layers of 2017 regulatory actions helps pharma construct a productive narrative
Karen Langhauser, Chief Content Director, Pharmaceutical Manufacturing

Unfortunately for mummies, their cinematic fame somewhat fell by the wayside when zombies took over as pop culture’s new favorite not-quite-dead terror.

Researchers, however, have not yet lost interest in mummies (apparently due to a widespread shortage of zombies in the scientific research community) and have now enlisted the help of X-ray technology to further their work.

Just recently – and for the first time ever – scientists, researchers and art curators utilized Argonne National Laboratory’s Advanced Photon Source synchrotron technology to look inside the linen-wrapped remains of an 1,800-year-old Egyptian mummy. The technology – the brightest X-ray source in the Western Hemisphere – speeds up electrons along a 3,600-foot circular track to produce high energy X-rays. The APS technology is used for research across a multitude of scientific areas on a regular basis. In the pharma industry, the X-ray technology can offer researchers a picture of a protein’s structure, which has aided in the development of inhibitor drugs such as Abbott Labs’ HIV drug, Kaletra, and Roche’s melanoma drug, Zelboraf.

As I wrote the December cover story for Pharmaceutical Manufacturing, (https://www.pharmamanufacturing.com/articles/2017/rx-reg-vision/) researchers in Illinois were using this advanced X-ray technology to non-invasively investigate the mummified remains of a five-year-old girl unearthed in Egypt in 1911 (I’ll let you decide whose job is more fun). While most would argue that pharma regulations come wrapped in red tape rather than resin-soaked linens, both tasks involve penetrating layers upon layers of details.

In the mummy’s case, using X-rays to study the wrappings, skeleton and internal matter enables researchers to gather clues that will shine light on the life, culture and trade networks of the Roman Empire. When speaking about pharma and regulatory intelligence, gathering and analyzing regulatory data against the backdrop of the industry enables manufacturers to derive meaningful outputs that can be used to guide regulatory strategy.

Essentially, it’s all about constructing a story, piece by piece. Personalized medicines, global harmonization and quality were the stars of 2017’s regulatory tale, while political change in the United States and Europe left mysteries that have yet to unfold.

X-ray technology is valuable to the study of these ancient artifacts because the mummies will be completely unharmed during the process. And it is our hope at Pharmaceutical Manufacturing that our yearly recap will provide our readers with a painless review of 2017 regulatory actions.

We can’t promise you immortality, but maybe we can settle on helping to preserve your regulatory sanity.