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.

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

NJM
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.

NJM - Dara SX-310-RDL Full View

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.

NJM - Dara SX-310-RDL CU
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 counterslabelersserialization solutions and more.

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

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MilliporeSigma @ INTERPHEX 2018

Millipore Sigma Logo
Mobius® Power MIX Single-use Mixers- Increase Your Capacity, Not Your FootprintM3159_171201_829 copy

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

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SP Scientific @ INTERPHEX 2018

SP Brands Logo_2016

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

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Finding New Roads

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.

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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.

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Changing Expectations in the Pharma Outsourcing Market

Nice Insight – Interphex 2017 March 23, 2017

While demand for outsourcing services remains strong in the pharmaceutical industry,spending is down and further decreases are expected. Service provides are faced with increasing competition and growing pressure to differentiate.

Pharmaceutical Market Remains Strong…

The global pharmaceutical market is currently expanding at a healthy compound annual growth rate (CAGR) of 6.3% according to EvaluatePharma. In addition, global pharma R&D spending is increasing at a CAGR of 2.8%. As a result, by 2022, the research firm expects 50% of added revenues to be derived from new products currently in the R&D pipeline.1 The market for active pharmaceutical ingredients (APIs) is growing at a similar CAGR (6.5%) and will reach $225 billion in 2021, according to Mordor Intelligence.2

Not surprisingly, healthy growth rates are also predicted for the global pharmaceutical contract manufacturing and research markets. Mordor Intelligence predicts the contract manufacturing sector will expand at a CAGR of 6.4% to reach $84 billion in 20213, while Grand View Research estimates the global healthcare contract research industry will grow at greater than 6.0% annual and be valued at $45.2 billion by 20224.

But Is Changing…

While growth remains strong, the pharmaceutical industry is faced with pricing pressure and expectations for new medicines that provide measureable added value. Drug manufacturers are challenged to be first to market with highly efficacious, cost-effective and demonstrably safe products and are consequently seeking efficiencies in all aspects of their operations. Reasons for outsourcing to contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) are thus changing.

While outsourcing activities were initially driven by the desire to reduce costs, for respondents to the 2016 Nice Insight CDMO Outsourcing survey, the top five drivers for outsourcing were improving quality and efficiency, gaining competitive advantage and operational / technical expertise and reducing the risk of supply shortages. 5 In 2017, the top reason for participants in 2017 Nice Insight Contract Development and Manufacturing Survey is access to specialized technologies.6 The other top four reasons are improving quality, gaining expertise, outsourcing is seen as a strategic activity and cost.

Similarly, for respondents to the 2017 Nice Insight Preclinical and Clinical Contract Research Survey, access to specialized technologies is the main driver for partnering with research firms.7 Other top reasons include improving quality, incorporating outsourcing in their strategic plans, and gaining access to operational, subject matter and regulatory expertise.

Contract service organizations that serve as long-term partners, act as extensions of their customers’ businesses and provide comprehensive, efficient, responsive and affordable support combined with access to novel and proprietary technologies will achieve the greatest success under these conditions.

With Continued M&A Activity …

Merger and acquisition (M&A) activity has occurred at a healthy pace in the pharmaceutical industry in recent years, including in the contract services sector. A total of 76 transactions involving service organizations were announced or completed in 2016, according to Capstone Partners, with sellers achieving high valuations with an average EBITDA multiple of 113.2x.8 Notably, nearly three quarters of the deals were made by strategic buyers. In the CDMO segment, Capstone reports that emerging and small pharma companies, which account for a growing percentage of pipeline candidates, require support across the full pharma development cycle from discovery through commercialization, which is driving M&A activity.8 The number of US CDMOs acquired in 2016 totaled 14.

The increasing complexity of clinical trials is driving demand for sophisticated CRO partners that have a broad range of advanced capabilities, according to Capstone.8 This need is a key driver of M&A activity in the CRO space.

CROs and CDMOs, as well as diversified testing, inspection and certification companies and private equity firms have also been busy acquiring analytical testing laboratories in order to meet the growing demand for cost-effective testing in the face of increasing regulatory requirements and the need to rapidly evaluate large numbers of pipeline candidates, according to Capstone.8

And Decreased Spending

Despite the healthy state of the market, the Nice Insight survey results for both the CDMO and CDMO sectors indicate a measurable decrease in spending by pharmaceutical companies on outsourcing activities.

Notably, the percentage of respondents to the 20165 and 20176 Nice Insight CDMO Outsourcing surveys with annual outsourcing expenditures of $50 million or more dropped from 71% to 56%, respectively. In addition, more respondents to the 2017 survey expect their companies to decrease (52%) rather than increase (39%) spending on contract development and manufacturing services over the next five years5 compared to 75% and 4%, respectively, in 20166.

A decrease in spending was also noted in the CRO sector; the number of drug manufacturers spending more than $50 million/year on contract research services dropped noticeably from 56% in 20169 to 47% in 20177, according to the Nice Insight CRO surveys. Also similarly, in 2016 nearly 75% of respondents expected spending on contract research services to increase9, while in 2017 that number was just 40%, with 50% predicting a decline in spending over the next five years7.

The reduced spending matches well the significant drop in the number of new drugs approved by FDA in 2016 – down from 41 in 201410 and 45 in 201511 to just 19 in 201612 as of November 29, 2016. On a positive note, around half of the respondents to the 2017 Nice Insight CDMO (55%)6 and CRO (48%)5 Outsourcing surveys expect their companies the number of CDMOs they partner with to increase.

Overall, however, the high level of M&A activity and the results obtained for the Nice Insight surveys suggest that competition in the CDMO and CRO marketplaces appears to be tightening, making it increasingly important for outsourcing partners to meet the quality, reliability, timeliness and other expectations of sponsor firms looking to outsource research, development and manufacturing activities.

BUT… Equipment spending Is Up!

Although they are decreasing spending on outsourcing, pharmaceutical companies appear to continue spending on equipment. Over one-third of respondents (38%) to the 2017 Nice Insight Pharmaceutical Equipment Survey have equipment budgets that exceed $100 million, a remarkable increase from 2016.13 In addition, 73% of respondents project budget increases in the coming years. A desire to increase productivity, lower costs, shorten the development timeline and access specialized technologies is driving the increased investment in equipment. The budget increases in 2017 may also indicate growing investments by small and emerging pharma companies to expand their in-house manufacturing capabilities.

References

  1. EvaluatePharma, “World Preview 2016, Outlook to 2022,” September 2016. http://info.evaluategroup.com/rs/607-YGS-364/images/wp16.pdf.
  2. Mordor Intelligence, “Global Active Pharmaceutical Ingredients Market – Growth, Trends & Forecasts (2016 – 2021),” September 2016. https://www.mordorintelligence.com/industryreports/ global-active-pharmaceutical-ingredients-api-market-industry.
  3. Mordor Intelligence, Global Pharmaceutical Contract Manufacturing Market – Trends and Forecasts (2016 – 2021) August 2016. https://www.mordorintelligence.com/industryreports/global-pharmaceutical-contract-manufacturing-market-industry.
  4. Grandview Research Inc., “Healthcare CRO Market to Reach $45.2 Billion by 2022,” January2016, http://www.grandviewresearch.com/press-release/global-healthcare-cro-market.
  5. The 2016 Nice Insight Contract Development & Manufacturing Survey.
  6. The 2017 Nice Insight Contract Development and Manufacturing Survey.
  7. 2017 Nice Insight CRO survey,
  8. Capstone Partners, “Pharmaceutical Outsourcing: Q1 2017.” March 2, 2017.http://www.capstonellc.com/sites/default/files/Capstone%20Pharmaceutical%20Outsourcing%20M%26A%20Report_Q1%202017_0.pdf.
  9. 2016 Nice Insight CRO survey,
  10. FDA, “New Molecular Entity and New Therapeutic Biological Product Approvals for 2014”http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm429247.htm
  11. FDA, “New Molecular Entity and New Therapeutic Biological Product Approvals for 2015”http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm,
  12. FDA, “New Molecular Entity and New Therapeutic Biological Product Approvals for 2016”http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm
  13. The 2017 Nice Insight Pharmaceutical Equipment Survey

 

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