Data Integrity by Shawn Sutton & Karl Balleza

Delta PM recently gave a presentation on Data Integrity and the process of establishing data integrity programs.  If you would like to learn more, please feel free to contact us directly or fill out the form below and we'll reach out to you soon!

 

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Delta PM Visits the ISPE Vertex Facility in San Diego!

Last week, our SoCal operations team (Feras, Colin, and Stacy) attended the ISPE Vertex Facility Tour.  The event was held in the newly completed company courtyard, overlooking the beautiful La Jolla neighborhood in San Diego.  The networking hour at the start of the event allowed us to connect with many people who were involved in the construction of the building and all of the finished labs and office spaces.  It was amazing to hear first-hand about the complexity of the building from those who will be using the building, like Maren Wight and Jon Hendricks. 

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The evening continued with a panel of people who worked to make the building possible, like the Operations Director of Vertex Pharmaceuticals, Jeff Barbee; the building owner from Alexandria Real Estate Equities, Chris Clement; and the Project Manager from BNBuilders, Nick Reikow, to name a few.  All of their answers to many of the questions regarding construction included the desire for an open concept and a fully integrated facility. 

We were lucky enough to see this state-of-the-art facility with Jeff Barbee and Nick Reikow guiding our tour.  The artwork, lighting, and glass curtains between each room gave the room a unique twist to the labs.  There was one point where we could see through a meeting room, through to the office space, and into the labs.  If the transparent design is suggestive of Vertex Pharmaceuticals, their team's culture, values, and work are definitely ahead of the industry!

CLSA's 3rd Anniversary Celebration in San Diego!

Last night, I attended the CLSA 3rd Anniversary Celebration & Open House of JLabs in San Diego.  The networking event was held outside of the lab with a wide array of vendors on the patio, overlooking La Jolla.  I spent a lot of the time having great conversations with CEOs, writers, researchers, and other professionals.  This was my first CLSA event and had a very fun time -- everyone was very welcoming and excited to be there! 

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Although there were a couple of vendors for foods and drinks, The Wine Militia did an amazing job pouring wine for the crowds.  They even hosted a Blind Wine Tasting, where 4 plain bottles were bagged and poured for guests to predict which wine was which red prominent varietal.  Everyone gathered around in curiosity and excitement to put their wine palates to the test.

The event concluded with an outstanding raffle, including prizes ranging from Amazon gift cards and wine picnic kits to even a drone!  I was lucky enough to win a home beer-brewing set!  Another big thank you to CLSA for hosting such a great event!
 

- Stacy Pham, Validation PM & San Diego Regional Lead at Delta PM

PDA Project Execution Excellence - BioMarin Gene Therapy Facility

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Logan Kelley and Carl Albertson presented on a recent Gene Therapy facility build-out at BioMarin. This project had received an award for project execution from ISPE and is also a current contender for the 2018 Project of the Year award.  The project excellence presentation was very interesting and it was amazing to see the completed 54-week timeline, as well as their internal observations of what went well and what could have been improved upon.

Some key takeaways from the presentation:

  • The client ensured that the complete project schedule was created and maintained (i.e. included all C&Q activities, not just up to the point of the GC handover to the client).

  • Some educated decisions and guesses were made without 100% of information known, such as the best placement of equipment process utilities, etc.

  • This fast-paced project required ongoing team energy and motivation, which was fueled by keeping in mind the positive benefits of the new product that would be produced at this facility.

  • Maximizing the use of disposable systems, in comparison to a stainless steel and hard-piped facility, resulted in a shorted a project timeline.  Some reasons for this are listed below:

    • Minimal parts washing and autoclaving cycles to develop and qualify
    • Minimal CIP

    • No SIP

    • Purchase of commercial off the shelf systems (COTS) minimizes need for extended FATS, and custom written IOQs
       

It was a pleasure to sponsor this event and learn more about how members of our industry are striving for excellence in all that they do.  A big thanks to PDA for hosting this wonderful evening and looking forward to seeing more of you at future events!

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ISPE Boston & The Biotechnology of Beer

As a Londoner of Iraqi origin, I developed an interest in the fermentation processes at a young age after visiting the British Museum.  I came across an exhibit that contained a Mesopotamian clay tablet emblazoned with cuneiform, which turned out to be the oldest recipe for making beer.  I felt an unusual sense of pride, and thus began my long and wonderful relationship with biotransformation and beer.

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Several weeks ago, Aaron Hubbell and I attended the ISPE Boston social and learning event at Jack's Abbey Barrel Room.  This event focused on biotransformation, including the technology of brewing and how this is applied on a commercial scale, as well as for the home brewer.  Kate Steblenko, a Beer Scientist (if only I knew this was a potential career path 25 years ago), kicked off the evening by discussing the new brewing technologies and the science behind these processes.  Kate walked us through the various strains used in making lagers, IPAs, and Belgian beers, in addition to the taste profiles they create.  Most striking to me were the parallels between our industries in how a variable, such as yeast strain, hop variety, addition timing, and fermentation temperature scheme, can dramatically impact the style and quality of the brew.  In the biopharmaceutical industry, we control the same variables: cell line, media feed strategy, and critical process parameters for a different outcome. 

After the brewing talks, several samples were passed out to the crowd to compare the subtle flavor profiles.  At this stage I QC'ed several of the local brews, which made the Q&A way more fun than it should be.  Many thanks to our host Eric Felz and the local ISPE leadership for putting together such a great event!

- Feras Al-Zubaidy, Executive Chairman at Delta PM

Meet Lee Anderson, Senior Quality Engineer at Delta!

1. How did you get into consulting?

I started consulting with a firm back in '95, then I got back into it after a lay-off in 2014.  After 25 yrs in the industry, I was familiar with all the local validation contractor and consulting agencies -- Delta was the obvious pick.  


2. What is different about Delta PM, and why do you enjoy consulting at Delta?

Delta PM has gone out of their way to find me interesting local work with a reasonable commute.  I enjoy working on challenging projects with a good team for support, and I also enjoy mentoring junior employees, teaching more advanced skills, and helping advance their careers.  Overall, Delta PM provides great employee support, both personal and technical, on a routine, day-to-day basis, or as needed.  You get a strong sense of being part of a team -- a team with a great, can-do, winning attitude.
 

3. How has consulting and the industry changed over the years?

Consulting has certainly become more common and there are now more agencies in the business.  As technology has advanced, there are more specialties needed, including Process Automation Technology (PAT), software validation, data integrity, single-use manufacturing systems, ready-to-use filled syringes, modular construction, spray dried drugs, and many more.  These are all technologies that were unheard of or just incipient when I first started out.  Furthermore, now the internet makes it a lot easier to get a cut sheet when you need it, whereas there was no internet when I got started in the industry.
 

4. Do you have any career advice or insights to share about consulting?

Your job security comes from your skill set and your network, so continue taking on opportunities to grow them.  Also, pay attention to communication, especially your writing -- use good sentence structure, proofread your emails, and develop good data presentation skills.  Don't assume you'll be understood you just because you know what you mean to say.

Welcome Aaron Hubbell - East Coast Regional Director

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I am very excited to announce the hiring of Aaron Hubbell, who joins Delta PM as our East Coast Regional Director!  Aaron will be based out of Delta's office in Cambridge, MA and will be overseeing our expansion in the immediate New England area, as well as the surrounding hubs of Life Science companies in the greater East Coast region. 

Aaron brings 18+ years of experience in various drug substance manufacturing functions, including Quality Assurance, Validation, Engineering, Operational Excellence, Training & Development, and Quality Control.  His most recent position was Sr. Manager, QA Validation at Lonza's site in Portsmouth, NH where he spent the last seven years of his career.  

Beyond Aaron's technical experience and expertise that he brings to Delta PM, I am most impressed by his personal perspective and vision on what we must do as a company to provide the best service to our clients and to become the employer of choice for other professionals in our area of expertise. 

Welcome to the team, Aaron! 

- Scott Kobayashi, CEO 

Why Technology Transfer is the Future - Ouiam Koubaa, Process Engineer at Delta PM

Our society demands speed and efficiency, and there is no exception in the world of manufacturing pharmaceuticals and biologics.  Technology transfer enables companies to manufacture their products without the expenditures associated with new facility construction and deployment.  Technology transfer makes this possible through transferring a process, even at a pilot scale, from the process designers and experts to a facility that has capabilities of large-scale manufacturing.  This can be particularly appealing to small biotech companies, which are often limited in experience, time, and resources to manufacture their products in-house.  The companies that own the technologies are called sending sites, and the facility that they work with to manufacture the product is known as the receiving site.  The sending and receiving sites of technology transfer can be the same company, but usually they are not.

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Delta Project Management has a client portfolio of both sending and receiving sites of technology transfers, and we anticipate booming growth in this field.  Recognizing this evolution, Delta PM hosted a Technology Transfer Night with ISPE, where we heard testimonials from both the sending and receiving sites of technology transfer.  We gained insight into Juno Therapeutics’ experience as a sending site to various Contract Manufacturing Organizations (CMO), and we also heard about Boehringer Ingelheim’s experience as a large-scale receiving site and a world-class CMO.

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While the sending and receiving sites are partners that collaborate to ensure the success of the released product, they also have unique responsibilities to meet this end goal.  As discussed by the panel at the event, this can sometimes mean the possibility of blurred lines between ownership of documents and deliverables.  The sending site usually owns deliverables, such as risk assessments, process control strategies, and process descriptions, but they also have the responsibility of ensuring that the manufacturing documentation produced by the receiving site, including batch records and work instructions, is consistent with initial process design.  This is particularly important to ensure product comparability when the sending site has multiple receiving sites for the same technology.  There is often a wide range of challenges on both sides of technology transfers, yet the plethora of advantages sustain this mutually beneficial partnership structure.  As we expand our presence in tech transfer, we will continue to invest in gaining knowledge and experience in this sector to deliver excellent services to Delta PM's current and future clients.