The Big Red Biotech Blog

The Rising Bar in Bio/Pharma Outsourcing

At a recent Biomanufacturing conference, participants agreed that more outsourcing would be seen in the industry.  They cited the following trends/stimuli as spurring this activity: greater globalization, increasing complexity of the supply network, emerging markets influence, and cost pressures.  More effort is therefore needed between pharma companies and their partners to better manage risk, secure supply, and guarantee product quality.

PharmTech Talk » PharmTech Biomanufacturing Partnership Conference: The Rising Bar in Outsourcing.

Since CMOs are now being looked to as key partners, there needs to be more transparency in interactions with pharma. This results in the creation of tools/systems for "on-demand" visibility to enable access to detailed project information, real-time information sharing, and track-and-trace capabilities.  This helps foster cross functional and cross company collaboration.

The tools also help optimize communications, manage expectations and provide metrics for evaluating performance.

Posted by Bruce Lehr Jul 26th 2012.

 

ADCs are Hot and Offer CROs/CMOs Opportunities

As covered in the BioProcessBlog, BPTC's first bioPULSE survey found that the market was bullish on the prospects of antibody drug conjugates (ADCs) to become a major therapeutic area going forward.

Increasing interest in ADCs.

Key findings in the web-based survey included:

• 83% of respondents expect to see a signifcant increase in the number of ADCs entering the pipeline in the next 5 years
• 24% indicated that they were not currently working on ADCs but expected to be doing so soon
• 24% indicated that they were already working on ADCs
• 95% of respondents said ADCs would be as big as mAbs or very important but not quite as big as mAbs (only 5% felt it was a niche application)

Conjugation technology and linker chemistry was seen to be the biggest challenge. Survey participants cited this as an opportunity for CROs/CMOs who could provide help with conjugation and linkers and provide manufacturing.  See Big Red Biotech posts here and here.

Posted by Bruce Lehr Dec 16th 2011.

Old "Car" Model Applied to "New" Pharma Industry

Fierce Biotech reports that some Pharma manufacturers are looking to the car industry for ideas on how to adjust their business model to be more profitable as well as perhaps shorten drug delivery times. Auto makers are very familiar with outsourcing many aspects of manufacturing and primarily concern themselves with design and marketing.  The pharma equivalent might be drug R&D and marketing.

GSK and AZ in particular were cited as two big pharma picking car makers' brains, drawing on companies like McClaren, Jaguar and Renault. In addition to outsourcing expertise, Porsche (for one) has crowed that it reduced product development time by 28%.  Contrast this by industry watchers claims that Big Pharma development times have increased by 31% -- there might be something to learn here.  Porsche actually has a consulting arm that is starting to market to pharma.

One big caution though -- auto makers haven't historically always been able to recoup their costs of capital -- not exactly a ringing endorsement for someone who wants to compete in pharma industry with dwindling capital markets to support it. Auto makers may have the most to teach in manufacturing and reducing costs there.

Interestingly, Pharmalot reported yesterday that 38 manufacturing plants were closed in the US this past year as pharma looked to downsize (and outsource like autos?).  While, Fierce reported on comments by Merck's CEO Ken Frazier indicating he would buck the Pharma R&D downsizing trend to continue to invest in R&D (consistent with auto internasl development model?) instead of cutting back R&D more severely (to also outsource) like GSK or Pfizer. The debate will rage as to which is best until more data emerges supporting a winner.

From an innovation standpoint though, it is good to see companies willing to consider other tried and tested business models for applicability to their situation -- especially cross industry like this.

Posted by Bruce Lehr Dec 15th 2011.

Contract Research Organizations Are Hot Hot Hot!

Two private equity firms paid $3.9 billion in cash for Pharmaceutical Product Development -- a CRO.  Why?  A recent RW Baird survey of 388 drugmakers and biotechs sheds some light on the matter. Namely, prices at CROs rose by 42% in Qtr2 (up from 33% in Qtr1).  This coupled with an expected increase of 3.6 to 8 percent in R&D budgets among drugmakers and biotechs makes the area look attractive.

Why Contract Research Organizations Are Hot // Pharmalot.

CRO clients report that their R&D budgets for outsourcing will go up on average by 9% again projecting good growth potential for the sector. CROs in fact have seen their share of market projects rise from 35% to 38% in 2011. The folks at RW Baird project over the very long term this might rise as high as 60 to 80 percent.

Further, "The vast majority of internal pharma staff surveyed believe that they are spending the same, or more, per unit of outsourced work today than in the recent past," writes RW Baird analyst, Eric Coldwell.

Thus the influx of private investors to a perceived market opportunity with the added bonus of NOT having to report quarterly earnings as seen in the public sector.

 

Posted by Bruce Lehr Oct 4th 2011 

Contract Manufacturing Will Explode for Pharma

In a new report, Visiongain says contract manufacturing in the pharma industry will hit $64 billion by 2016 and more than double in the next 10 years. The manufacturing of final dosage forms is expected to grow fastest (CAGR 8.7%) - though making APIs still constitutes more than 71% of the total market.

US companies currently enjoy a 42% masrket share of contract manufacturing business, but this is expected to change as India and China are increasingly, successfully competing in this segment. The Asia and Pacific region is expected to grow by 9.6% annually over the next 5 years compared to an overall market rate of 6.7%. 

While these emerging regions are expected to grow more rapidly in the next 5-10 years, analysts also expect that costs of labor and raw materials will rise over time dampening the rate of future growth.  Markets can be expected to level out to a greater degree as the industry establishes its global footprint. See Pharmalot.

Posted by Bruce Lehr Aug 23rd 2011.

 

CMOs Look for Double-Digit Growth in 2011

According to a GEN article (July, Vol 31, No. 13, page 40), CMOs are guardedly optimistic that the segment has overcome the recent economic downturn and will be poised to grow in double-digits in the at least the near term.  Many have recently added capacity and are now turning their attention to create added flexibility for their clients, often using single-use disposable systems to accomplish the task.  CMOs are also enhancing their offers in the their service portfolio. 

Lonza, KBI BioPharma, Wacker Biotech, Boehringer Ingelheim, CMC Biologics, Cytovance and DSM are among those CMOs who have added recent capacity -- incorporating more use of disposables, raising their ability to meet regulatory requirements and increasing downstream capabilities. 

Despite the lack of availability of venture capital to their small and mid-size clients -- which has hurt business -- CMOs see more trends in the positive direction that give them optimism that they will see double-digit growth in 2011.  They say more companies are focused on advancing candidates in their pipelines rather than broadening them which should lead to more late stage projects in CMOs.  Also, Big Pharma is beginning to divest manufacturing capacity in favor of outsourcing it to CMOs as a strategy.  And, biosimilars and biobetters are coming on the scene to provide more projects and volume.  Finally, the biotech is going global which brings more customers in from Asia Pacific and other emerging markets.

There remain some concerns.  A few CMOs mentioned the possiblility of over-capacity in the industry once again as CMO capacity is also coming on in Asia and emerging markets leading to more competition.  That's certainly a trend that I'm seeing in my work -- primarily as a consequence of more biosimilar and biobetter companies emerging in those regions. So as many of the trends may be positive as compared to a the past few years, it still looks like a very competitive marketplace and companies will have to continue to differentiate their service offerings to maintain good margins and flow of business.

Posted by Bruce Lehr July 5th 2011.

R&D Spending In India Is Projected To Mushroom

A recent Boston Consulting Group (BCG) study has projected that R&D spending in India will increase from $2 B last year to more than $25 B by 2025.  Much of this increase will be attributed to Big Pharma in the West shifting work to India.  In BCG interviews with 40 Big Pharma Execs, 70% indicated they were happy with their alliances in India and 75% said they expect to increase activities.

R&D Spending In India Is Projected To Mushroom // Pharmalot.

The reasons behind this shift are not hard to fathom:

• Lower costs.  Trials currently run 60% less than in the US.
• Good pool of treatment-naive patients. India sites also recruit 4x faster.
• Growing pool of qualified researchers

Among drugmakers, Pfizer, GSK, Lilly and Novartis ran the most trials -- together accounting for about 1/3 the total in India.  I guess Lechleiter is Ok with farming out all clinical trials despite all whinging about immigration policy and working in the US.

The most cited impediments to doig even more work in India, include: lack of coordination with alliance partners, insufficient support from senior management [at partners], and differences in executing plans. Regulatory uncertainty and the intellectual property landscape are also viewed as somewhat unsettled. None of this seems to be slowing down current growth -- and you can likely expect that to be maintained until cost advantages start leveling out as compared to the West.

 

 

 

 

Posted by Bruce Lehr June 29th 2011.

 

Oncolytics Biotech inks deal with SAFC for its cancer drug

Oncolytics announced it has signed a pact with SAFC in a commercial supply agreement for its cancer treatment, Reolysin. Financial terms of the agreement were undisclosed.

Oncolytics Biotech inks commercialization deal for its cancer drug.

SAFC will supply clinical  and commercial materials from its vaccine CMO facility in Carlsbad, CA.  SAFC worked with Oncolytics to develop and optimize the manufactuirng process used for Reolysin, a modified virus designed to treat head and neck cancers.

"The agreement represents a significant step forward in the drive to commercialize Reolysin as we prepare to produce expanded clinical supplies and build inventory for potential commercial sales," said Matt Coffey, COO for Oncolytics.

 

 

Posted by Bruce Lehr May 16th 2011.

 

 

 

 

 

 

 

 

 

 

CROs Serve More Biobetter Small Biotechs Clients

A quick hitter from Outsourcing-pharma.com.  CROs like Charles Rivers report a noticeable increase in development services are being requested by innovator pharma, generics and biobetter small biotechs as they attempt to introduce follow on biologics. 

Biobetter biotechs emerge as preclinical services clients.

Many of the biobetter companies are small -- and many times virtual -- and rely on an outsourcing development model.  They're buying services like assay development, preclinical toxicology, pharmacokinetics and other biobetter development work. The surge in demand has really upticked in the past two years.

Biobetters do not try to mimic existing biologics and won't use the as yet unspecified FDA pathway for biosimilar approval, but must follow the same path as innovator drugs.  However, as biobetters are targeting proven drug targets with "enhanced properties" of some sort, their failure rate (and therefore risk) is considered to be lower.  Though one might argue the technical risk is lower but the commercial risk is high unless the enhancement is differentiating and important to imporved patient care. Nevertheless, it appears that many smaller firms are going to test this route and will need help to do so.

Posted by Bruce Lehr May 16th 2011.

Strategic deals to drive market share gains for big CROs

This article from Outsourcing Pharma states that Big Pharma will increasingly look to outsource to CROs as it tries to reduce R&D expense.  In doing so, it will consolidate and form strategic partnerships with a limited set of global CRO players. 

Strategic deals to drive market share gains for big CROs.

The top seven CROs (includes Covance, PPD, Parexel, Charles River, Icon, Kendle and Quintiles) will have captured half the market by 2015 as big pharma, especially Pfizer, enters into these strategic deals.  Pfizer will streamline its supplier network into functional service providers (FSP) and niche players. Pfizer terms this new model "performance partnerships" and will likely emerge with a short-list of 5 (or less) strategic vendor relationships.

Analysts say that "Within 5 years, and potentially much sooner, we could see over 80 percent of sponsors engaged in some sort of strategic relationship." In light of this, the CRO industry is expected to split into two groups -- large, global providers working in strategic relationships, and niche providers focused on one or two therapeutic areas.

Time to cement that partnership now if you want to be on the strategic short-list.

 

 

 

Posted by Bruce Lehr April 20th 2011.

 

Viehbacher: One-man R&D Wrecking Crew

According to Seeking Alpha, Chris Viehbacher, CEO of Sanofi-Aventis and Chairman of PhRMA, is stickng to a familiar theme -- that is remaking the pharma model by de-emphasizing in-house R&D.  He says the industry has failed to get an adequate return on its investment in R&D and therefore needs to tap the greater world of ideas by externalizing R&D. 

"My goal as CEO is never to inaugurate a new research and development center," said Viehbacher.

Instead, Sanofi has outsourced up to $2.2 billion in R&D with Covance over the next 10-years - and cut translational research agreements with Harvard University and The Charite University in Berlin.

This thinking must be catching on.  Readers here will note a post from Matthew Herper's blog yesterday that recounts a loss of nearly 300,000 pharma jobs in the last decade - with more than half of that in the past 3 years. 

The LIfe Sci VC blog carried a post yesterday about the rise of CROs -- and how companies like BMS, Takeda, Sanofi, Lilly, GSK etc have inked deals in the past couple of years to outsource large chunks of R&D work to CRO partners. 

The author, Bruce Booth, goes on to predict "that more and more virtual or semi-virtual biotechs will be funded that require less infrastructure and focus increasingly on an asset-centric model of innovation and less on platform-centric capacity building.  These startup biotechs are only able to "go virtual" by leveraging the emerging breadth, expertise, diversity and cost consciousness of the global CRO industry."

It looks like less Big Pharma R&D is on our horizon to stay.

Posted by Bruce Lehr April 15th 2011.

CEO: Sanofi may provide Genzyme with fill/finish long term

Sanofi's CEO, Chris Veihbacher, said that the parent corporation may look to provide fill/finsh capability to Genzyme following the completed acquisition.  He stressed, however, that any such move woudl be further in the future as Sanofi will concentrate on executing Genzyme's existing manufacturing recovery plan following the deal close.

CEO: Sanofi may provide Genzyme with fill/finish long term.

So for the near term, Hospira can rest soundly on the knowledge that it will continue to provide fill/finish services for Cerezyme and Fabrazyme until supplies can be built and stabilized.  Over the past two years, both these drugs have been plagued by supply issues due to problems at Genzyme's Allston manufacturing site - which is still operating under FDA oversight as part of the consent decree.

Posted by Bruce Lehr Feb 17th 2011.

A Closer Look at the Capacity Glut

This interesting post from the BioProcess Blog examines the worldwide capacity for mammalian cell culture based manufacturing.  It notes recent studies have concluded there is a worldwide excess.  But, in looking deeper one really needs to examine the 10 companies that control 80% of the world's capacity. 

A Closer Look at the Capacity Glut.

Due to mega-merger activity, some capacity is being retired (or mothballed) as the merged firms rationalize their internal production.  Examples would include Pfizer's shutting down capacity in Pearl River due to the Wyeth acquisition, and Roche's closing manufacturing in Nutley and mothballing Vacaville-2 near SF.  Lilly is also closing one Erbitux plant (BB-36) due to its age. These reduce "world" supply but clearly are not needed by the companies shuttering them to produce their planned production.

A few new CMO facilities are slated to be coming on line - namely DSM's Australian facility in 2013 and CMC's expanded Seattle site.  BI also announced last month that it will be taking over the Fremont manufacturing site from Amgen. There is some suggestion in this activity that CMO capacity needs to ramp up and that is further bolstered by Lonza's earnings report showing its capacity utilization is up.

The blog notes that 10 new products have progressed to phase II in the past few months and 50% will go to CMOs.  This includes GSK utilizing Lonza to make 5 of its new antibody drugs. So with the growth on the CMO side, will that specific capacity be enough to serve the market's needs or will CMO space be scarce resulting in price competition between clients to secure needed space?  We'll need to watch in the next few years.

Posted by Bruce Lehr Feb 15th 2011.

Informex 2011: Tracking the Fortunes of Chemically Synthesized APIs

This article from the PharmaTech Talk blog comes to us from this year's Informex meeting in Charlotte, NC. It summarizes the pressures faced by US small molecule API manufacturers in a rapidly competitive and shifting environment.

PharmTech Talk » Informex 2011: Tracking the Fortunes of Chemically Synthesized APIs.

The gist?  Big Pharma is increasingly consolidating its vendor base.  It is looking to outsource more of its operations to gain flexibility. It is looking to both cut costs and to access emerging markets -- and can do so in one fell swoop by establishing more relationships with manufacturers in places like India and China.

Couple this with the issues Big Pharma is having with its dwindling pipeline, patent cliffs and recognition that large molecules, rather than small , are the more vigorous growth engines of the future -- you have a strong movement toward non-US API manufacturers.

Again, this is another reason, the US goverment needs to get behind our biotech industry to maintain its growth and prosperity so we can further develop a sustainable leadership position.  There are not that many industries where we still have clear leadership and it would be a monstrous mistake to let this one go too.

Posted by Bruce Lehr Feb 8th 2011.

Genzyme Sells Intermediates Business to ICIG

As reported in In-Pharma Technologist, Genzyme will sell its pharmaceuticals Intermediates business to International Chemical Investors Group (ICIG).  Thus, Genzyme has fulfilled its goal of selling its 3 non-pharma businesses (genetic testing, diagnostics and pharma intermediates) to allow it to focus on the core pharma business.

Genzyme to sell intermediates biz to ICIG.

The pharma intermediates unit makes lipids, peptides, carbohydrates, oligos and custom small molecules for pharma customers. It will be renamed Corden Pharma and will continue to operate out of Liestal, Switzerland. ICIG will continue to make clinical trial supplies for Genzyme's phase III Gaucher's disease drug, eliglustat tartrate. ICIG will make make other drugs too used in early clinical trials.

 

Posted by Bruce Lehr Feb 2nd 2011.

Speaking of Outsourcing R&D and Cost Cuts - We Give You Pfizer

Pfizer announced several moves today pertaining to its R&D groups in multiple facilities as it looks to trim $1.5 B from its previous R&D budget.  The cuts will result in layoffs of 2400 R&D employees and the closing of its Sandwich, Kent facility.  Pfizer also announced that several operations will be shifted from its Groton, CT site to Cambridge, MA -- about 1125 employees will be affected by the move. Pfizer will also stop several disease programs - including allergy and respiratory in Sandwick, antibacterials in Groton, regenerative medicine in Massachuesetts,  The programs may be totally disbanded or in some cases outsourced. Programs in neuroscience, CVS and metabolic diseases will be shifted to Massachuesetts as well.

The cutbacks were announced with Pfizer's latest earnings statement as the company faces huge expected revenue losses in the $9-10 B range with the expiration of its patents protecting Lipitor - the World's best selling drug. Talk about a patent cliff - better be a rock climber if you are working in R&D there.  For more see Pharmalot and Fierce Biotech. 

 

 

 

 

 

Posted by Bruce Lehr Feb 1st 2011.

Bold Outsourcing Will Help Big Pharma Cut Costs

Big Pharma outsourcing will become much bolder in the next 12-18 months as companies attempt to dramatically attack cost structures, according to Covance's CEO, Joe Herring.

Increasingly bold outsourcing will help big pharma cut costs.

The trend will be supported by the looming patent cliff written about in this industry as well as by the development of a strong CRO industry that can take on the extra work. Big Pharma now has direct experience with numerous CROs and recognizes their value in replacing duties once performed in-house. The further benefit of being able to reduce internal staffing is also highly relevant.

Success of previous strategic alliances has been particularly important, said Herring. Many people thought the Lilly deal would fail but two years on both companies are happy with the transaction.  Similarly, Sanofi offered its Porcheville, France and Alnwick, UK sites to 30 companies, but it was Covance that could make the deal work. Having made deals with Sanofi and Lilly, as well as Merck & Co, Covance is now the CRO people think of when considering making a strategic transaction, said Herring.

Since acquiring Lilly's Greenfield, Indiana site, Covance has added a number of capabilities while keeping costs down. Furthermore, the deal gave Covance the employees and capabilities to enter the drug discovery support sector which Herring predicts will grow.  More deals are expected by Covance thorughout the industry in 2011 and coming years.

 

Posted by Bruce Lehr Feb 1st 2011.

 

Boehringer buys Amgen site to expand biologics CMO biz

Boehringer announced it will acquire Amgen's Fremont manufacturing site to further extend its global contract development and manufacturing capability for biologics.  The Fremont site came to Amgen via its acquisition of Abgenix for $2.2 B in 2006.  The Fremont site is 100,000 sq ft and houses 360 employees. It has previous experience producing panitumumab, Vectibix, commercially.

Boehringer buying Amgen site to expand biologics CMO biz.

The acquistion enhances Boehringer's global footprint.  It adds capability to its main manufacturing site in Biberach, Germany, and manufacturing and development partnerships that it has with Avid Bioservices and Kemwell in India. Financial terms of the Boehringer acquisition were not released but the company is supposed to take over the site formally in March.

 

 

Posted by Bruce Lehr January 20th 2011.

SAFC Completes High-Potency Fermentation Expansion in Israel

  

SAFC announced the completion of its state-of-the-art expansion of its Jerusalem, Israel facility. The additional capacity expands SAFC's contract manufacturing capabilities in large molecule recombinant proteins and small molecule Active Pharmaceutical Ingredients (APIs) through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.

The 50,000 sq. ft. cGMP fermentation expansion, which is expected to begin production in October 2010, will focus on niche fermentation of APIs and bulk drugs, producing secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. A 30,000 sq. ft. area of the new facility has been designed to be Biosafety Level 2 compliant - enabling manipulation of human pathogens. Capabilities include 1,000 and 4,000-liter tank capacities for bacterial and fungal fermentation, as well as explosion-proof suites.

"Fermentation is a long-standing technology, yet new applications have been recently discovered, including the synthesis of high potency compounds, which is a major growth area currently driving contract manufacturers such as SAFC to look beyond traditional active pharmaceutical ingredient (APIs)," said SAFC President, Gilles Cottier.  See here for full release.

 

 

 

 

Posted by Bruce Lehr October 6th 2010.

Manufacturing Issues for High Potency Drugs under cGMP

My colleague Trevor Calkins, director of process development and manufacturing, wrote a nice article in the latest (Sept) issue of BioProcess International on the manufacturing and handling of high potency APIs.  Trevor is located at our HP-API facility in Madison, WI.

As Trevor points out, HP-APIs are a key component in the manufacture of antibody drug conjugates (ADCs).  With the increasing success of Seattle Genetics SGN-35 for Hodgkin's disease and Roche's T-DM1 for the treatment of breast cancer, ADCs are expected to play a larger and largers role in the pipelines of companies developing new oncology drugs.  SAFC has invested heavily in two state-of-the art manufacturing facilities for HP-APIs - both in WI - and serves as a key outsourcing option for the manufacturing of HP-APIs and ADCs. 

Trevor's article discusses the challenges and capabilites that a manufacturer must have to handle these difficult products.  He describes engineering controls and personnel training/protection embodied in the Madison and Verona facilities that allow safe manufacture of these key compounds under GMP conditions - in these multipurpose facilities. (Link to isolator photo inside Madison facility).

Pharma magazine also has coverage on SAFC HPAPI expansion plans.

 

Posted by Bruce Lehr October 3rd 2010.

Get Reddy - Aurobindo to Supply AZ with Generics

Chairman PV Ramprasad Reddy announced that Aurobindo has signed its second major generics supply deal with an MNC - this time with AstraZeneca.  Its previous generics licensing deal was with Pfizer.  The AZ deal calls for Aurobindo to provide generics - both solid dosage forms and sterile liquids - for disease categories covering anti-infectives, cardiovascular and CNS drugs.  The products will be branded AZ and sold to emerging drug markets. See in-Pharma Technologist.

Posted by Bruce Lehr September 6th 2010.

Congress Moves Again on Drug Safety and Quality

Drug safety is an important enough topic that I am going to provide another post from the PharmaTech Talk blog that addresses the new Senate legislation proposed to enhance drug safety. 

PharmTech Talk » Congress Moves Again on Drug Safety and Quality.

The blog post provides links to the bill, Drug Safety and Accountability Act of 2010, as well as to statements from interested parties like the Society for Chemical Manufacturers and Affiliates (SOCMA), the Bulk Pharmaceuticals Task Force (BPTF), and the Pharmaceutical Research and Manufacturers of America (PhRMA).  SOCMA and the BPTF supported the proposed legislation effusively.  PhRMA was a bit more reserved in its response, noting that GMP requirements are followed now whereever a drug is manufactured for the US market (or at least are supposed to be).

Posted by Bruce Lehr August 4th 2010.

Senate bill would bolster drug safety requirements

Drug safety is a hot topic again.  Sen. Bennet introduced legislation this week that would enhance the FDAs enforcement powers and hold drug companies more accountable for products that they sell.

Senate bill would bolster drug safety requirements - The Hill's Healthwatch.

The bill would update FDA data systems for tracking drugs globally, force drug manufacturers to document ingredients in its supply chain, grant FDA subpoena power, and empower the FDA to order recalls for safety reasons.

This comes in the wake of a record number 1742 recalls in 2010 -- a 400 percent increase over 2008. You can read more related to the topic of supply chain and risk management in Changing the Concept of Quality at SAFCLive.com. 

Posted by Bruce Lehr August 4th 2010.

SAFC's Verona CMO for HPAPI and ADC Manufacturing

 As evidenced by the Seattle Genetics and Genentech deal announced today, high potency active pharmaceutical ingredients (HPAPIs) and antibody drug conjugates (ADCs) are seen as important new technologies within the oncology fields.

The idea of targetting a cancer cell with a potent payload of toxin that hits the mark is a powerful new tool in the cancer fighting battle. It is also a means by which companies can take their naked antibody drugs and create a new drug with lengthened market life and improved effectiveness.

Recognizing the trends in this area for some time, SAFC has been a leader in manufacturing capability for high potent products.  We have had the Madison, WI site for a number of years and have just opened a new facility in Verona, WI that extends our capability for manufacturing HPAPIs or ADCs by using state of the art containment designs.

in-Pharma Technologist.com is hosting a video interview with Dave Bormett, the SAFC Director Operations for its new Verona site. Follow the link for an exclusive look inside the facility. 

Posted by Bruce Lehr August 3rd 2010.

 

 

 

 

 

 

SAFC's - Enhanced Quality Program (EQP)

I've written quite a number of posts on this blog about the increasing need in the bio/pharma industry to have better characterization, control and traceability on raw materials being used in the process of producing drugs.  The regulatory bodies around the world - FDA, EMEA, etc - clearly are placing more and more emphasis on this need.  Quality is paramount in the production of safe and efficacious products.  The very public incidents of quality lapses with major manufacturers only serves to heighten this concern - whether the incident stem from a China, US or EU based manufacturer. 

Several previous posts highlighted SAFC's new raw material characterization program aimed at better characterizing and qualifying materials used in cell culture based manufacturing of biopharmaceuticals. You can review these here, here, here, here and here. (Told you, I've posted about this before).  You can also refer to the popular Raw Material Detective series of posts for some real life examples.

Now, SAFC introduces its Enhanced Quality Program (EQP^SM).  The EQP is designed to transparently show customers the Quality levels associated with the large number of SAFC products that could be used in manufacturing.  This is meant to aid customers in choosing the RIGHT product for their application - as quality needs are application specific in many instances.  EQP levels differ in their degree of quality certification, documentation and change control. EQP products fulfill a range of needs from industrial applications through the more heightened controls of the biopharma and pharma industry.  Premium, Elite and cGMP levels exist within EQP.

EQP is consistent with ISO requirements and meets international standards for multiple industries. One of the significant features of the EQP is the Change Control Notification (CCN) program. Customers may subscribe to this program at www.safcglobal.com/ccn.  On our website, customers can also search on CAS numbers to determine if we have a product that meets your Quality needs.  If not?  Customers may request an upgraded product and our compliance specialists will be able to determine through consultation whether we can accomodate that change.

For more information, refer to the links in this post - and on overview can be found on this attached flyer.

Download MOU_EQP Flyer_LR

 

 

Posted by Bruce Lehr July 24th 2010.