Welcome to another posting of ‘Industry Insight with Chester,’ a periodic round-up of news and views from around the Pharma and biopharma industries compiled by Chester Solack, Business Analyst at SAFC in Lenexa, Kansas.
Archive for the ‘Regulatory’ Category
Industry Insight with Chester: A Collection of Current Industry Updates
Friday, May 18th, 2012Contract Pharma Outsourcing Survey 2012
Tuesday, May 15th, 2012Contract Pharma recently released their annual Outsourcing Survey where the publication takes time to poll players in the pharma industry on hot button outsourcing topics. The survey is broken out by size of company, specialty of company and title of the responders and as a whole, it offers exceptional insight into the current landscape of outsourcing and upcoming trends. The full report can be found by clicking here.
A Deeper Look Into the Bulk Pharmaceutical Task Force
Wednesday, May 2nd, 2012In April, SAFC Live highlighted Patty Benson’s participation at the ICH Q3D Metal Impurities Workshop in Bethesda, Maryland as part of a panel presentation where she provided an API supplier’s perspective. As a follow up to that piece, we sat down with Patty to discuss the Bulk Pharmaceutical Task Force (BPTF) in more detail. Here, she offers insight into who the BPTF is, what they do, what they are currently working on and what the future holds. The full story follows:
SAFC Reports Record Q1 Earnings
Friday, April 27th, 2012This week, SAFC announced record Q1 earnings. As noted by Sigma Aldrich President and CEO, Rakesh Sachdev, in the Q1 earnings call the results were contributed to strategic initiatives and acquisitions. He noted that, “Aided by the acquisition of BioReliance, SAFC sales of $197 million achieved a new quarterly high.” The growth was also contributed to an ever evolving global market that SAFC has committed to moving and changing with. Sachdev continued, “In addition to pharma outsourcing, the emerging markets continue to benefit from a strategic emphasis that the countries in these markets place on Life Science research.”
Q1 serves as a lead into even greater expectations for SAFC’s continued organic growth throughout 2012 and beyond. Sachdev provided further detail about these expectations, “With 1% organic growth for SAFC in Q1, we continue to expect sales growth to achieve low- to mid-single-digit organic growth in the second quarter as it is impacted by the same tougher comps related to the pre-buy in the SAFC Bioscience business in 2011, a slightly weaker LED market and capacity constraints in Hitech, which will be progressively alleviated beginning in the second quarter as our new Taiwan plant comes online.”
For the full Q1 2012 earnings report, please click here.
An API Regulations Update from the ICH Q3D Metal Impurities Workshop
Friday, April 20th, 2012As SAFC Live previously reported, the ICH Q3D Metal Impurities Workshop was held from April 4-5, 2012 at the Marriott Bethesda North Hotel in Bethesda, Maryland. The program focused on the new limits for element impurities in drug products and how they may impact businesses in the pharma industry. On day one, SAFC Quality Assurance Director, Patty Benson, participated in a panel titled “Perspectives From Active Pharmaceutical Ingredient (API) Suppliers”, along with a lineup of speakers from industry colleagues, the IPEC-Americas, CHPA and SOCMA’s Bulk Pharmaceutical Task Force (BPTF). The panel talked about draft guidelines and data implications, and their impact on pharmaceuticals. Patty’s input from an API maker’s perspective was complemented with an excipient user perspective from Janeen Skutnik-Wilkinson, Director of Quality and Regulatory Policy at Pfizer Inc. and an excipient maker perspective from David Schoneker, Director of Global Regulatory Affairs at Colorcon.
Patty’s presentation in the “Perspectives From Active Pharmaceutical Ingredient (API) Suppliers” panel is available for reference here: Q3D BPTF 0412.
To learn more about SAFC, please click here.
BREAKING NEWS: SAFC Launches CHOZN® Platform System to Accelerate Recombinant Protein Drug Development
Wednesday, April 11th, 2012Today, SAFC announced the launch of the CHOZN® Platform System to accelerate recombinant protein drug development. The new platform allows faster and simpler selection of high producing clones for use in recombinant protein drugs, as well as facilitating a more efficient scale-up process. The full press release is available below.
BREAKING NEWS: Sigma-Aldrich Acquires Research Organics to Strengthen Portfolio of PharmaGrade Raw Materials
Tuesday, April 3rd, 2012Yesterday, Sigma-Aldrich announced the acquisition of Research Organics, a leading supplier of biochemicals for use in various bioprocessing, biotechnology and diagnostic applications. The addition means that SAFC will now be able to offer dual sourced buffers, as well as an expansion of the raw materials catalog of products. As executives for both companies noted, the acquisition has been made with an end goal of increasing quality of service and capacity to partner with customers on both standard and custom project solutions.
To read the full press release, please click below. To learn more about SAFC’s line of PharmaGrade Products, please click here.
