Archive for the ‘Facilities’ Category

Winter 2013 Clearance Newsletter from BioReliance

Monday, December 2nd, 2013

The Winter 2013 edition of BioReliance’s Clearance Newsletter is live with a special focus on the identification and optimization of processes suitable for viral clearance, including a look at the BioReliance Complete Clearance solution and other insights on study design for vaccine products. The update also features current legislative and regulatory changes for raw materials details of BioReliance activity in the last quarter. To read the Winter 2013 update, click here.

BioReliance also recently offered a look into mycoplasma contamination and testing, which can be accessed by clicking here.

Any questions or requests to be added to the quarterly distribution list can be directed to internal regulatory expert, Susan Rennie, at susan.rennie@bioreliance.com.

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

BioReliance is an Exhibiting Sponsor at the 2013 PDA/FDA Advanced Virus Detection Technologies for Evaluation on Biologics Conference

Monday, November 11th, 2013

BioReliance is proud to be a Platinum Sponsor, exhibiting in Booth 7 at the upcoming 2013 PDA/FDA Advanced Virus Detection Technologies for Evaluation on Biologicals Conference this week from November 13th to 14th at the Bethesda North Marriott in Bethesda, MD.  (more…)

BREAKING NEWS: SAFC® Partners with CatScI Ltd. to Offer Breadth of Catalytic Reactions and Related Services

Tuesday, November 5th, 2013

SAFC has partnered with UK based catalysis company CatScI, Ltd. The companies have aligned in a non-exclusive partnership to offer CatScI’s expertise in catalyzed reactions and complex chemical processes and support from SAFC for process development, scale-up and manufacturing of high-value products. Read the full press release below.  (more…)

SAFC Lives: Patrick Klipstine, Global Director of Project Management

Monday, November 4th, 2013
Patrick Klipstine, Global Director of Project Management

Patrick Klipstine, Global Director of Project Management

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 Patrick Klipstine, Global Director of Project Management, in Madison, WI.

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Fundamentals Of Viral Clearance Studies – Part 5: How Much Is Enough?

Tuesday, October 29th, 2013

We hope that you have been enjoying Dr. Kathryn Remington’s viral clearance series as featured in Bioresearch Online.

In Part 5: How Much is Enough, the final article of the series, Kathryn provides insight into what level of viral reduction is required to achieve an acceptable viral safety risk and how that can vary for each product. In addition, she speaks to the approach regulatory agencies take to the level of viral reduction based on the potential viral load of the starting materials.

Here is a look back at the first 4 parts of the series:

Please note that if you are not already registered with Bioresearch Online, you will need to do so for full access of the content. Free registration to Bioresearch Online can also be initiated through any of the following: Twitter, LinkedIn, Facebook, Google, Yahoo, or OpenID.

To learn more about the BioReliance offering, please click here.

To learn more about finding success by outsourcing products and services to SAFC and BioReliance, please click here.