Tag Archives: Pharmaceutical

Boehringer Ingelheim Discovers the Golden Batch with Real-Time Data

The story of pharmaceutical production is often a quest for the golden batch: a repeatable process that consistently optimizes yield and quality. But pursuit of the golden batch can be a perilous process. Compliance with government regulations is always a chief concern for biopharmaceuticals; results must fall within a narrow framework or Proven Acceptable Range (PAR) of acceptable variability. Add in the complexities and variance inherent in working with a biological process to create your product, and the quest for the golden batch quickly starts looking like a narrow mountain pass on the road to El Dorado. A vision of a golden land lies before you. Meanwhile, you face the threat of avalanches from above and the possibility of steep falls into deep ravines below. For an animal health subsidiary of Boehringer Ingelheim, a top international pharmaceutical company, their quest for the golden batch began with a seemingly simple question: what if?

 

 

 

 

Will A. Penland, Principal Data Scientist, at Boehringer Ingelheim, Animal Health, and his team began looking at the fermentation process they use to produce vaccines and asking themselves if there were ways they could improve it. What if they could reduce product variation? What would it take to reach pharmaceutical El Dorado? Penland and his team knew that their biggest problem was variation, which can arise at many points in the production process. The sheer number of different potential sources of variation makes this a critical but difficult question to answer when pursuing the golden batch.

For Penland and his team, the answer seemed to lie with using multivariate data-analysis techniques (MVDA) and advanced statistical modeling. But implementing MVDA presented another set of obstacles. Gaining a better understanding of process variability meant monitoring their process at many different levels. To use their data analytics software, the team needed a way to first aggregate and contextualize all the data from all these potential sources of variation.

 

 

 

 

 

Multivariate data analysis and batch evolution modeling enable Boehringer Ingelheim to gain insight into their drug fermentation process

The PI System turned out to be the right robust software to help Penland and his team of data scientists on their journey. The PI System allowed them to bring their diverse data streams together, aligning their SCADA, LIMS, process control, and attribute data, with their time-resolved spectroscopic data. Using OSIsoft’s Asset Framework (AF), they created a data modeling hierarchy for different types of data streams related to the fermentation process. The team also triggered process steps within their programmable logic controller and used a step numbering system to create Event Frames in AF to identify important process events. They now use Event Frame to keep a close eye on the various stages of the fermentation process, particularly the growth phase.

The PI System did more than just enable their advanced data analytics and batch evolution modeling. The success of any quest is often a question of mindset and the PI System brought benefit in this area too. “We have a data driven mindset now,” Penland recently said of himself and his fellow colleagues. “We are asking how do we interpret this and what is the data telling us rather than having a more reactive knee jerk response, fighting fires all the time.”

To find out more, register for OSIsoft’s webinar entitled ‘Boehringer Ingelheim – The Quest for the Golden Batch‘ on the 5th September at 3PM London/10AM New York

Register Here!

Expert interview with Robert Gaertner, speaker of ‘Transform Change Management with a Modern QMS’ webinar.

What do you hope the audience will learn from this webinar?

I expect that most of our audience will have a deep quality background and will be familiar with the basics of change management. So, the focus of this webinar is to provide practical advice.

The pharma industry is undergoing a transformation that has a significant impact on the effectiveness and efficiency of change management. This webinar will explore why change management needs to be modernized and key steps required to achieve this.

What discussions do you look forward to having with the audience?

I would like to understand what tactics quality units are currently applying to cope with the constantly increasing number of post-approval changes. And whether there is a more strategic approach to this where technology can support the process.

What do you enjoy most about your role?

It’s very easy – as Veeva’s strategy lead for quality in Europe, I have the unique opportunity to have a lot of interesting discussions on burning industry topics. This webinar is a good example!

How did you get into the industry?

There are a lot of life sciences companies in the region I’m from. My first student job was in a quality control lab and I joined the quality management department with the same company after graduating. It’s always good to learn things from the ground up!

Where is your favourite place in the world and why?

Definitely Barcelona! You wouldn’t find another large city in the world with the perfect combination of culture, beachfront, nightlife and good weather. There might be a reason why Veeva’s European Headquarters are located there!

Join Robert Gaertner on 19th July for a webinar entitled ‘Transform Change Management with a Modern QMS’ at 2PM London/3PM CEST

 

Jim Sinisgalli – Director of Market Development, UniSecure

Jim SinisgalliJim Sinisgalli is Director of Product Management – Brand Protection. He presently leads and guides Systech’s anti-counterfeit and authentication business to develop strategies which protect brands from counterfeit, diversion and other illicit trade.

His role in developing and executing Systech’s authentication strategy allows him to work with brand leaders across numerous industries. Jim’s more than twenty-year career as a visionary leader includes half of his career spent protecting customers’ most precious assets from data to physical product.

What are the implications of “Smart” labels and packaging for the consumer?

Labels and packaging today increasingly have scannable codes directing the consumer to engagement websites.  This is typically quite a lightweight interaction today.  But if we make the interaction have a greater value to the consumer, that will create a much greater opportunity to increase customer loyalty.

What do you see as the most important challenge that your industry faces in the next 5 years?

As a brand protection solution vendor, we have seen great investment across the industry fighting counterfeiting, diversion and the overall gray market.  Yet, statistics show that despite this investment, counterfeiting and diversion are still increasing.  In the next five years, we need to see a high level of adoption of these new technologies like we’re talking about in this session to be able to minimize this global and sometimes life-threatening problem.

Why is “Smart” packaging and labelling so important for organizations?

There are a number of reasons these are important: revenue, consumer or patient safety, traceability, consumer engagement and brand loyalty.  Increasing the overall value and positive experience with a product via these advancements in “smart” packaging creates an even deeper bond between brand and customer.

What should the audience expect to learn from the webinar?

Establishing trusted product authenticity is the first step in deriving value from “smarter” packaging.  Once authenticity is established, being able to uniquely identify each and every product in the field creates opportunities for bi-directional communication between a brand and consumer that we have never before seen.  We will explore the possibilities!

Be sure to  join Jim and Systech International in their upcoming webinar ‘Make Your Current Package or Label “Smart” and Able to Communicate‘ . 

Jim Sinisgalli – Director of Market Development, UniSecure

Jim SinisgalliJim Sinisgalli is Director of Product Management – Brand Protection. He presently leads and guides Systech’s anti-counterfeit and authentication business to develop strategies which protect brands from counterfeit, diversion and other illicit trade.

He is responsible for developing and executing Systech’s authentication strategy working with leaders across products and services, and sales. Jim’s more than twenty-year career as a visionary leader includes half of his career spent protecting customers’ most precious assets from data to physical product.

Tell us a little about Systech International, what does the company do?

Systech is the global technology leader in product safety, and consumer and brand protection. In brief you could say that we pioneered serialization and are defining the future of authentication.

Offering revolutionary anti-counterfeiting technologies, authentication solutions, and supply chain data visibility applications, Systech makes customer’s brands more secure and the resulting data more accurate, valuable and actionable. As supply chains become more complicated and counterfeiting threats continue to grow, we will continue to be at the forefront of innovation.

How did you get into the industry?

Given Systech’s long history with vision/inspection solutions and being the first to introduce serialization, we have been on packaging lines for over 30 years.  We saw the capabilities of our solutions to take a barcode and be able to inspect it so closely we can differentiate between each and every one.  It was a natural fit to introduce this as a cutting edge anti-counterfeiting and brand protection solution.

Why did you choose to hold this webinar?

We try to collaborate and to engage with our customers wherever possible. Systech is in the middle of a very exciting time. Counterfeit products not only affect consumers but also result in huge losses for the manufacturing companies. We have experienced a great interest in UniSecure, our brand and product protection solution, and we have a lot of expertise that we can share, and solutions we believe would be useful to this community.

What are you looking forward to discussing with the audience?

It will be a great opportunity to brainstorm with the audience on leveraging their existing packaging, and the possibilities when we transform it into an anti-counterfeiting device.  Once you can identify each and every product, what can you do with that?

What is the most rewarding aspect of your job?

Systech has worked primarily with pharmaceuticals, our brand protection solution is popular in pharma, but introduces us to such a wide variety of other industries.  It is very rewarding to work and learn in these other market spaces to solve their pressing issues.

Be sure to  join Jim and Systech International in their upcoming webinar Protecting Your Brands Against Theft and Counterfeiting in 2017 and Beyond‘ . 

Dr. Andrew J. Reason, CEO and MD, BioPharmaSpec

dr-andrew-j-reasonFollowing a Ph.D in “Characterization of O-linked GlcNAc in nucleoplasmic and cytoplasmic glycoproteins” and a short period of postdoctoral research at Imperial College, Andrew joined M-Scan in 1994 as a biochemist, and rose to become Managing Director of the M-Scan Limited and M-Scan GmbH laboratories. 

Andrew is Managing Director and CEO of BioPharmaSpec, a CRO he co-founded with Prof. Howard Morris early in 2014.

You have said anyone developing a biosimilar should attend this webinar. What would be the key takeaway message for the audience?

Structural Characterization is at the core of demonstrating comparability of Biosimilars to Reference Medicinal Products (RMPs). Successful development of a Biosimilar is always underpinned by a strong analytical package. This webinar has been designed to provide attendees with some understanding of the regulatory requirements and analytical package requirements to characterize and compare Biosimilars with RMPs.

What do your clients tell you is the biggest challenge in developing a pipeline of biosimilars?

Biologics are complicated to manufacture at the best of times. Biological processes are hard to control, and manufacturing a Biological to be comparable with a Reference Product is very difficult. Each product has its own individual challenges but it is usually the Post Translational Modifications (PTMs), and glycosylation in particular, which are hardest to control and represent the biggest challenge in producing a Biosimilar.

Unlike many other small-medium sized CROs, BioPharmaSpec has invested in having labs in different locations- how important is this global presence?

As well as our laboratories in Europe and North America, BioPharmaSpec also has a global Sales/Business Development presence with offices in Europe, North America, India and South East Asia. We feel it is important to be close to our clients and provide local business and technical support across time zones. This allows us to be on hand when needed and to act as an extension of our client’s in-house product development team.

You are a visiting Professor at the University of Warwick. How do academic collaborations support and advance the biopharmaceutical industry?

Academic collaborations allow small to medium-sized companies like BioPharmaSpec to explore and develop new processes and methods. For example, through my visiting Professorship at Warwick University we are investigating the power of combining data obtained from Circular Dichroism, FT-IR, Raman Spectroscopy and NMR for secondary and tertiary structure analysis of Biopharmaceuticals.

Throughout your career, you have travelled all over the world to present at conferences and meet with clients. What has been your favourite place and why?

It is very hard to choose as I have been lucky to visit so many places and meet some fantastic people. I think if I had to choose one place it would be San Francisco because as well as it being an interesting place to do business due to the large number of innovative start-up companies, there are also plenty of great golf courses in the Bay area! I always try to visit Napa and Sonoma for the wine tasting when I am there.

Join Andrew and BioPharmaSpec in their upcoming webinar Effective Biosimilar Comparability Studies”. Register now!

Paul Daniel, Senior Regulatory Expert, VAISALA

Paul Daniel, Senior Regulatory Expert at Vaisala, has over 19 years of validation experience in the pharmaceutical and medical device industries.

Paul has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network, and computer validation, and extensive practical grounding in applying the good manufacturing practices principles of the FDA 21 CFR Parts 11, 210, 211, and 820.

An expert in authoring and executing validation protocols for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines. Paul holds a bachelor’s degree in biology (with honors) from the University of California, Berkeley.

What is your favourite thing about presenting on webinars?

It is an opportunity for me to give something back to the professional Life Science community which has given me a rewarding career in Validation.

What are you looking forward to explaining to the audience?

Mean Kinetic Temperature (MKT) is a really interesting topic. There is a deep and engaging story in the history of MKT that is intertwined with the history of HVAC and monitoring technology, and heavily influenced by ongoing regulatory changes in Good Distribution Practice. I am looking forward to sharing this story, so that we can see how our understanding and use of MKT has changed over the last 40 years, and hopefully, have a better idea of where this unique tool can be used effectively today.

What attracted you to the industry and what do you enjoy most about working at VAISALA?

I became involved in Pharmaceutical Validation because I was good with details, and I was seeking an industry where my work would have a direct link to improving quality of life. I joined Vaisala over 4 years ago because I thought it would allow me to be more effective at influencing positive change within my industry. I really like Vaisala because this company is dedicated to making the world a better place, one measurement at a time. Our mission statement – Observations for a Better World – conveys this idea. And, I really enjoy working with excellent people, in an established international company, that continues to create technology that changes the world. I may work in the narrow niche of Temperature Monitoring for Pharmaceuticals and Medical Devices, but Vaisala is involved in a much wider scope of enterprise that includes weather, road safety, interplanetary exploration, and preserving cultural treasures. I can’t imagine a more exciting place to work!

What is your favourite holiday destination?

I don’t have a favourite. But if you gave me two-weeks off and an expense account, there are a few places you would likely find me; high in the Colorado mountains fly-fishing an isolated stream, riding a mountain bike on remote single-track trails in the Pyrenees, or asleep in the sun on a beach in Mexico.

How did you spend the Easter holiday?

Easter was spent with friends and family, enjoying the return of spring, sitting in the sun, and talking about our hopes for the coming year.

Join Vaisala’s webinar with Paul on “Mean Kinetic Temperature in GxP Environments”. Register here.