There was a great amount of discussion about the status of outsourcing in the pharmaceutical industry as 2012 came to a close; the discussion continues in 2013, perhaps with more attention than ever before. While the outsourcing trend is on an uptick, many companies that do choose to outsource limit the functions that they are willing to outsource. Often, the goal is to fill the most dramatic gaps they perceive in their core competencies while still keeping as much process in house. However, there is much more that a CMO can offer when fully integrated into pharma processes. (more…)
Archive for the ‘Facilities’ Category
Supply chain security continues to be a major customer issue across various industries. In the biopharma industry specifically, the public outcry for quality and transparency has caused a great deal of change in the global regulatory environment and in many company’s approach to the way they do business. SAFC is no exception.
As a company that likes to stay ahead of the trends, quality has long been a focus area for SAFC. From employing various global teams dedicated to quality and supply chain transparency, to re-categorizing product offerings to include fully validated products, SAFC has been busy working on answering this industry need.
Originally launched in 2012, SAFC’s PharmaGrade portfolio addresses the need for greater supply chain transparency and enhanced quality for biopharmaceutical manufacturing applications. Products in the PharmaGrade portfolio are provided with full documentation of manufacturing history, and are compliant with either GMP (Good Manufacturing Practice) standards or the SAFC Elite Quality grade standards. All PharmaGrade products are quality assurance reviewed and released, and include applicable change control notification, plus a dedicated product support team.
Here, SAFC’s own Beth Ann McLane, product manager for enhanced quality, talks supply chain security with Cynthia Challener of Pharmaceutical Sciences, Manufacturing, and Marketplace Report. The following feature titled Strategies for Achieving Biopharmaceutical Supply Chain, takes a look into how SAFC is ensuring supply-chain transparency and quality for raw materials with the PharmaGrade line.
The PharmaGrade line recently expanded to include 20 new products, and SAFC expects the portfolio to double in size by the end of 2013.The full press release on the expansion can be found by clicking here.
To learn more about PharmaGrade, please visit: www.safcglobal.com/pharmagrade
The seminar will be hosted on Thursday, April 25th at The Westin Chosun Hotel, and is an ideal opportunity to take part in an informative day of talks with BioReliance experts who can advise on current issues and new innovations in biosafety testing. Key topics to be addressed during the day include:
- Regulatory Updates
- Virus Risk Mitigation for Raw Materials
- Massively Parallel Sequencing for biosafety testing
- Biomanufacturing Case Studies
- Biosimilars (worldwide regulatory expectations and bioassays for potency)
- Viral Clearance (impact of filter variability)
- Molecular Methods for biosafety testing
Refreshments, lunch and a drinks reception at the end are included in the session. A full agenda with speaker profiles and the annual seminar schedule can be found by clicking here.
What are the key factors of working with HPAPIs and what will the future bring?
Click here to read a panel discussion about the considerations of working with HPAPIs and the trends for the future. Trevor Calkins, Director of Process Development and Manufacturing at SAFC, weighs in about SafeBridge Certification, manufacturing technique, ADCs and more.
SAFC and BioReliance had a busy week across the globe as a handful of announcements went live offering a look into expanding product lines and facilities, newly acquired licenses and a promotion to President of SAFC.
SAFC Expands the Irvine, Scotland facility to include dry powder media capability and offer redundancy with Lenexa facility. Click here for the full release.
The PharmaGrade line grows to 80 products, with plans to double by end of 2013. Click here for the full release.
Archie Cullen named President of BioReliance, with an official start date of April 1, 2013. Click here for the full release.
BioReliance acquires the colonies required for the Big Blue® transgenic rodent mutation (TRM) assay. Click here for the full release.
BioReliance looks forward to hosting the upcoming technical seminar: Essential Updates for Biologics Manufacturers. The seminar is available at the Radison Blu Royal Hotel in Copenhagen, Denmark on Tuesday, March 12th, 2013 and at the Renaissance Amsterdam Hotel in The Netherlands on Tuesday, March 19th, 2013.
As the leader in Biologics Safety Testing and Manufacturing Services, BioReliance hosts many complimentary seminars throughout the year. The events are aimed at providing customers and partners with the most up to date information in the industry. (more…)
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 are not playing a critical role in the ongoing growth of SAFC.
In this edition, we talk with Erik Klahn, R&D Manager, SAFC Cell Sciences and Development at the Lenexa facility in Kansas. (more…)