Archive for the ‘Facilities’ Category

Video exclusive: in-Pharma Technologist Takes a Look Inside SAFC’s Verona, Wisconsin HPAPI Facility

Tuesday, August 3rd, 2010

“Greater recognition of toxicity risks of HPAPIs and continued growth of oncology sector are driving drug industry demand for safe manufacturing capacity says” writes Gareth MacDonald of in-Pharma Technologist, talking about the rationale behind SAFC’s recent $30m expansion of  its Verona, Wisconsin HPAPI facility.

Gareth was invited to enjoy an exclusive look behind the scenes at the Verona plant’s capabilities and spoke about the market with operations director David Bormett, who also gave an insight into the containment technologies used at the plant, as well as the trends and growth that SAFC is seeing is the field of  highly potent compounds, which offer greater efficacy in smaller doses in numerous areas of medical treatment, particular in the development drugs that target cancers.

Forget MTV Cribs… The really fascinating stuff is happening here

“Contained but not constrained” – Trevor Calkins talks high potency facility design and considerations with Cleanroom Technology

Monday, July 19th, 2010

Highly potent drugs require specialized manufacturing facilities to ensure they do not escape into the environment.  In this exclusive article with Cleanroom Technology, SAFC’s Trevor Calkins describes in detail, from the initial stage of a project through potency classification to specific design and containment specification,  how the company designed its multipurpose manufacturing plants to meet the complex containment requirements.

Read the full article here

Sunshine, positive industry vibes, one cutting edge-HPAPI facility and Wisconsin highways all feature as SAFC’s global media summit is a hit in Chicago…

Friday, June 18th, 2010

The first ever SAFC Global Media Summit was held in Chicago last week and was attended by 11 journalists from leading chemical, pharmaceutical and bio trade publications from Europe and the United States.  Having previously held separate events in Europe and North America, the Chicago summit was the first ‘global’ event to be organized by the Company.

Hosted by a senior executive team from SAFC comprising President Gilles Cottier, VP of Marketing Ed Roullard, VP of Sales and Operations Dave Feldker and VP of Quality and Regulatory Affairs, Tom Beil, the event was hosted in downtown Chicago.  Proceedings kicked off on the evening of Tuesday 8th June with an informal drinks reception, which was welcomed by the journalists, many of whom had travelled from Europe to attend.  The event kicked into high gear the following morning with a series of briefings held in the Dana hotel’s 26th floor Sky Lounge.  Luckily the previous night’s torrential rain had abated, to be replaced by glorious sunshine, which enabled the party to take full advantage of the spectacular views afforded by the outdoor balcony area.

Cottier: Solid Q1 sales growth of 9%

Following an early breakfast, Gilles Cottier gave an overview of recent SAFC business highlights, including impressive Q1 sales growth of 9%, current and expected market trends and an insight into SAFC’s business strategy. Among the future trends identified by Gilles were the challenges and opportunities in emerging markets, continuing quality and supply chain concerns and the shift from small molecules to biologics. Gilles then looked to the future and talked about growth through SAFC’s customer intimacy model for key strategic accounts and the improvement of profitability thorough plant process improvements, facility rationalization and the roll out of SAFC’s ‘Center of Excellence’ facilities initiative.

The next presentation was given by Tom Beil, who examined quality issues in a changing regulatory environment and how events such as heparin and melamine contamination of the supply chain have accelerated the need for total supplier transparency. Tom then went on to describe SAFC’s Enhanced Quality ProgramTM (EQP) which aims to mitigate risk by finding the right balance between product quality and cost. Tom finished the presentation by giving an outline of the activities of the Rx-360 consortium and in particular, progress being made in the area of shared supplier audits.

The first two presentations sparked some interesting conversations over the coffee break before Dave Feldker resumed proceedings, talking about SAFC’s differentiating technologies and the Centers of Excellence initiative. With over $175 million invested in high potency and biologics technologies over the past five years, SAFC continues to expand its technology portfolio in line with customer needs and market trends. The Centers of Excellence will be based around this technology footprint and are designed to enhance service to pharma and biopharma customers through optimization of manufacturing process, quality and supply chain.

Finally Ed Roullard described SAFC’s Customer Intimacy approach to client service and the ways that dedicated account managers with a deep understanding of their key accounts position SAFC as a partner and solutions provider rather than just a product supplier. Ed then talked about how this model was being applied in the Asian and Latin American markets before summarizing the key messages from the day and highlighting the ways in which SAFC continues to evolve.

There was great demand for one-to-one meetings with all the SAFC executive team over lunch, with meetings continuing up to three hours after the presentation had finished. Feedback from the journalists on the content of the presentations was excellent with many identifying article opportunities for the remainder of the year.

Pilot Plant at SAFC's Madison, WI. facility

Dinner on the Wednesday evening was held at a restaurant located on the 40th floor of a Chicago skyscraper, which once again provided breathtaking views of the city.  Wednesday evening also happened to coincide with the Chicago Blackhawks winning the Stanley Cup for the first time in 41 years, which saw the streets of Chicago transformed into one big, noisy party until the early hours of Thursday morning. Despite some resulting sleep deprivation, the battle-hardened band of journalists gathered early on Thursday morning to set off on a coach trip to SAFC’s new $30 million High Potency Active Pharmaceutical Ingredient (HPAPI) manufacturing facility, located in Verona, near Madison, Wisconsin.

Opened earlier this year at an official ceremony attended by Wisconsin State Governor Jim Doyle, Mayor Jon Hochkammer from the City of Verona and Secretary Dick Leinenkugel from the Wisconsin Department of Commerce, the 51,000 sq. ft. facility was constructed to complement SAFC’s existing 63,000 sq. ft. HPAPI plant in Madison to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs, the Verona plant features the same state-of-the-art facility design and containment engineering as the Safebridge® certified Madison site but on a larger scale.

In a development very out of character, the European editors found themselves in a bar...

Following a bone jarring three and a half hour trip, (Wisconsin Highways Department, take note), the party was greeted at the impressive new plant by Dave Bormett, Operations Director for both Wisconsin facilities. Dave then gave a tour which took in state-of-the art development laboratories, a 150 liter mini-processing plant as well as the large scale cGMP manufacturing suites, quality control laboratories packaging area and warehousing space. This was the first visit to a HPAPI facility for many of the journalists including one of the teams who filmed throughout the tour for forthcoming features on their site – watch this space for a link which will be posted on SAFC Live shortly.

It was time to bid farewell to the US based journalists at this stage while the hardy European contingent braved Wisconsin roads and the Chicago rush hour once more, the five hour return journey making the evening meal and drinks at a local pub taste all the sweeter.

Lenexa next as SAFC invests in developing Center of Excellence for seamless dry powder media and reagents production

Tuesday, May 4th, 2010

ON April 27th SAFC® announced a $6.25 million investment program to expand its Lenexa, KS. facility, creating a global ‘Center of Excellence’ for the seamless upstream and downstream production of dry powder media and reagents. The investment, part of SAFC’s worldwide facilities initiative, is designed to better serve the biopharmaceutical industry by creating ‘Centers of Excellence’ for manufacturing and supply chain optimization.

The project, supported by a $250,000 economic development grant from the Kansas Bioscience Authority, will include expanded pin milling and blending capabilities, enabling an increase of approximately 30% in batch production capacity. The expansion is expected to be completed by the end of 2010.

(more…)

A Risk-Based Approach to Establishing Animal Component Free (ACF) Facilities

Monday, February 22nd, 2010

In this ‘Vendor Voice’ article from December 2009’s BioProcessing International, Thomas Pamukoglu from SAFC Biosciences maps out the step-by-step process that the company went through at its Lenexa, KS facility in order to become ACF.

Link To Article

Link for more information