Archive for the ‘HPAPIs’ Category

SAFC Lives: Kevin Kolell, Ph.D., Global Head of Technical Sales

Thursday, February 13th, 2014
Kevin Kolell_headshot

Kevin Kolell, Ph.D., Global Head of Technical Sales

SAFC Lives presents personnel profiles where we talk to the people and personalities who make SAFC tick to find out more about their position, what drives them and what they enjoy doing when they’re not playing a critical role in the ongoing growth of SAFC.

In this edition, we talk with Kevin Kolell, Ph.D., Global Head of Technical Sales, based in Lenexa, KS. (more…)

SAFC to Speak at 2014 World ADC Summit Europe in Frankfurt, Germany

Tuesday, February 11th, 2014

SAFC is proud to sponsor the upcoming 2014 World ADC Summit in Frankfurt, Germany, February 17-20. Held at the Maritim Kurhaushotel Bad Homburg, the annual ADC Summit brings together leaders in the research and development of next-generation medicine and targeted therapeutics from across the globe.

In addition to sponsoring the event, SAFC will also be leading a discussion on Antibody Drug Conjugates (ADCs). Dr. Cynthia Wooge, Global Strategic Marketing at SAFC, will address “How to ensure success in technology transfer for ADCs while avoiding pitfalls,” at 9:00 a.m. on Wednesday, February 19. Her presentation will feature information about successful transfer to ensure robust and reproducible conjugation processes. Additionally, Cynthia will highlight the use of solid analytics to aid in the understanding of process controls and product characterization, appropriate engineering design, and the importance of effective communication.

Full event details can be found by clicking here.

In Q4, SAFC announced plans to further invest in ADCs with a commercial ADC facility expansion and additional HPAPI manufacturing capacity, as well as took part in various industry discussions about this exciting and novel technology. To learn more about SAFC’s full ADC offering, click here.

Cell Line Engineering and the Pursuit of the “Super CHO”

Friday, January 17th, 2014

SAFC’s cell line engineering team is continually working on enhancements to the proprietary CHOZN® Platform. Our latest enhancements target identifying genes that eliminate the possibility of immunogenic variants, and knocking out potentially problematic CMAH and GGTA1 gene sequences.

Growing interest in immunogenicity within the biopharmaceutical industry has continued to drive SAFC’s R&D into the existing CHOZN Platform, with the ultimate goal of creating a “Super CHO” expression system consisting of cell lines, vectors, media, and feeds that provide maximum output of biotherapeutic proteins with higher titers, better growth, and increased cell longevity.

In an interview with Cynthia Challener of Pharmaceutical Technology, Kevin Kayser, Senior Director, Head of R&D, talks about what sets the CHOZN Platform apart, predicts increased demand for these types of cell lines, and provides an insight into what the team is working on for the future.

Read the full interview by clicking here.

To learn more about SAFC’s CHOZN Platform, click here.

The Holidays are a Time for Giving Thanks!

Monday, December 23rd, 2013
Workers at Manna Food Center sort the food donations.

Workers at Manna Food Center sort the food donations.

Off-loading food donations to Manna Food Center.

Off-loading food donations to Manna Food Center.

It has been a bit quieter here at SAFC Live in the month of December as everyone prepares for time off during the holiday season. We can hardly believe that 2013 is almost over and wanted to take a moment to say THANK YOU for your support in 2013.

The teams at Sigma-Aldrich, SAFC and BioReliance strive to show our thanks to the communities we operate in through the year. In 2013, the team at BioReliance implemented various projects for charity and provided a great example of how giving back is not only rewarding, but also fun.

Employees volunteered time to various programs, participated in charity runs and walks, coordinated lab tours for local students and provided monetary support to local charities like the Joshua Frase Foundation (supporting myotubular myopathy treatment research). As the holidays approached, the team turned their attention to making the holidays brighter for local families with over 500 toys donated to the local chapter of Toys for Tots, and 2,186 pounds of food donations to Manna Food Center (www.mannafood.org) as part of the Sigma Aldrich global food drive. The success of the toy drive is driven by departmental toy exchanges where Secret Santas buy toys for co-workers instead of the traditional coffee mug.

We are sincerely appreciative of the communities we work in, our exceptional employees and valued partners – none of this is possible without you – and so we leave 2013 with our deepest thanks.

Best wishes for the happiest (and healthiest) of holidays and a prosperous new year. We look forward to seeing you on SAFC Live in 2014!

 

The Changing Landscape of Contract Manufacturing

Thursday, December 12th, 2013
Dr. Andreas Weiler, Global Head of Strategic Marketing at SAFC

Dr. Andreas Weiler, Global Head of Strategic Marketing at SAFC

Just over a month ago, SAFC was onsite in Germany with 34,000 pharma professionals from across the globe for the annual CPhI Worldwide event. Leading into the event and during time onsite, contract manufacturing was on everyone’s minds as the changes in the pharmaceutical market continue to transform the traditional definitions for growth, competition and success in this sector.

For contract manufacturers looking to stay competitive and increase market share, the evolution of the industry can mean a myriad of things. SAFC’s own Global Head of Strategic Marketing, Dr. Andreas Weiler took part in multiple conversations about the status of the pharmaceutical industry, what he projects for the future and how SAFC is operating its own custom manufacturing services and solutions division in the changing market.

Prior to the show he was featured in a Pharmaceutical Technology industry roundtable titled, Gaining Insights on Contract Chemical API Manufacturing. While onsite, Dr. Weiler spoke with Biopharma-Reporter.com about how changes in the market are fostering interest and investment in specialized technologies and treatments, particularly the development of antibody drug conjugates (ADCs), in an interview titled, “The sexiness of the ADC world”.

To read more about how the perceptions of outsourcing contract manufacturing services shifted in 2013, click here.

To learn more about Dr. Andreas Weiler and his position with SAFC, click here.

BioReliance Sponsors the 10th Anniversary of bioProcessUK

Monday, November 25th, 2013

Screen Shot 2013-11-25 at 11.26.36 AMBioReliance is looking forward to sponsoring the 10th Anniversary of bioProcessUK next week from 3-4 December at the BMA House in London. There will be a full team onsite at the conference to network with industry colleagues and host an educational workshop. Parent company SAFC is also getting involved at bioProcessUK as a sponsor of the Tuesday evening casino featured during the hosted Black Tie Gala dinner at the Grand Connaught Rooms.

On day two, (Wednesday, December 4th) Senior Director, Alison Armstrong will chair a workshop on Biologic and Analytical Testing for Novel Cell Therapy-based Products. Alison will guide the panel of participants from Retroscreen, Oxford BioMedica, IntertekSchweiz AG and Cell Therapy Catapult as they gather to look into the scientific and regulatory issues associated with the production and testing of novel cell therapy products. The workshop will highlight the latest developments in analytical techniques and equip attendees with tools and strategies to navigate the technical and regulatory challenges in the clinical development process.

Over the past ten years, BioReliance has participated in the conference and watched it evolve for the promotion and advancement of the biological medicines sector in the UK and abroad. To learn more about the event click here. To see the full programme of interactive workshops available to attendees, click here.

Rx-360 Commits to Change: A Discussion with Founding Board Member, Tom Beil

Thursday, November 14th, 2013

 

Tom Beil at the Rx-360 panel discussion

Tom Beil at the Rx-360 panel discussion

Rx-360 is a global quality consortium with a mission to “protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain”. Comprised of regulators, pharmaceutical executives, supplier executives and other industry figures, Rx-360 members are dedicated to patient safety. The group strongly advocates collaboration for quality to ensure that counterfeit drugs do not enter the market.

Vice President of Quality and Regulatory Affairs at Sigma-Aldrich, and Rx-360 founding board member, Tom Beil is committed to affecting positive change in the pharmaceutical industry. Rx-360 posted an in-depth interview with Tom on this passion, and his experience working with both manufacturers and suppliers to define expectations, identify challenges, and develop a solution for sharing best practices among the industry. In it, he acknowledges that the supply chain is ever evolving and points out that while it is important to recognize what is wrong, the ultimate focus should be on how to make it right. To read the full interview with Tom, click here.

Earlier this year in, Tom participated in a panel discussion at Informex in Anaheim, CA where Rx-360 members joined to examine new ways to improve supply chain security and auditing. The discussion was featured in the June edition of Contract Pharma, and can be found by clicking here.

Tom also hosted a Pharmaceutical Technology webcast on quality with industry colleagues during the month of June. The recap of the webcast may be found by clicking here.

To learn more about Rx-360, or to join, please visit www.rx-360.org