Why Is Biomanufacturing So Hard?

Earlier this year, the Cambridge-based biotech firm Genzyme announced the latest in a series of manufacturing delays for Fabrazyme, a biological drug that treats a rare genetic disorder, after one lot of the drug was found to be contaminated. The news followed a more severe setback in 2009, when both Fabrazyme and another drug were contaminated with a virus; the problem closed the manufacturing plant and created major shortages.

Genzyme isn't alone in these issues. Biologics?drugs made through a biological process rather than chemical synthesis, a category that includes recombinant proteins, vaccines, and antibodies?are the fastest-growing segment of the pharmaceutical industry. In 2008, nearly 30 percent of revenue from the top 100 drugs came from biologics, a figure that is expected to rise to 50 percent by 2014.

But the same factors that make biologics powerful drugs also make them a challenge to manufacture. They typically mimic proteins and other molecules found in living organisms and can target harmful entities, such as some cancer cells, with great accuracy; many of the most promising new drugs for cancer and other diseases fall into this class. Biologics tend to be larger, more complex molecules than drugs synthesized through chemical reactions, which adds to production challenges and makes them costly. A single dose of some biologic therapies can cost $10,000.

Biologics are most often produced by cells growing in a bioreactor, a vat designed to maintain carefully calibrated conditions. Because the cells are alive, "every time you run a reactor, the result can be a bit different," says Chris Love, a chemical engineer who is part of MIT's Biomanufacturing Research Program. This inherent variability makes the process both expensive and unpredictable.

Another issue is that for biologics to win approval from regulatory agencies, it's not enough for the drug itself to be approved, as is the case with small-molecule drugs; the manufacturing procedure must be approved as well. While this is important for safety's sake, it also makes it costly to change the production process after it's been approved, and that discourages innovation. "By the time the drug is in the marketplace, you are working with old technology," says Charles Cooney, a chemical engineer at MIT. "You have to lock in the technology many years before launch of a commercial product."

And even when developing experimental drugs, makers tend to stick with methods that have previously been proved safe. As a result, new advances in systems biology and microtechnology have not been integrated into biomanufacturing, says Love.

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Behind Battle Over Debt, a War Over Government

What makes a bipartisan ?grand bargain? so elusive is less the budget numbers, on which compromise could be in reach, than each side?s principles, which do not lend themselves to splitting the difference. President Obama wants deficit reduction, including tax increases for wealthier Americans and corporations. Congressional Republicans, prodded by a cadre of junior lawmakers, want a vastly smaller government constrained by lower taxes. The two are not the same thing.

Mr. Obama will make his case on Friday in a White House news conference, his third in just two weeks.

However this showdown is settled, it seems increasingly likely to define not only the legislative record of this Congress, divided between a Republican-controlled House and a Democratic-controlled Senate, but also the 2012 elections and Mr. Obama?s prospects for a second term.

The two sides met for less than two hours at the White House on Thursday, even as attention appeared to shift away from the prospect of a bipartisan budget agreement to the likelihood of a backup plan to raise the debt ceiling before the Aug. 2 deadline.

Having discussed spending cuts in past White House meetings, the negotiators considered the administration?s proposals for raising taxes, which Republicans have vowed to oppose. Mr. Obama previously had said they would meet again on Friday to decide whether they could reach a deficit-reduction deal; if not, they would spend the weekend negotiating a way to raise the $14.3 trillion debt limit, and defer the bigger budget-cutting clash.

Instead, at the end of Thursday?s session, he told the lawmakers to try to work something out and be ready for his summons to a weekend meeting.

Underlying the budget drama between the White House and Congressional Republicans is another compelling drama among Republicans, which exposes an ideological and generational gap. On one side are older, more senior conservatives like the two top leaders, Speaker John A. Boehner and Senator Mitch McConnell, the minority leader, who remember the budget fights and Republican setbacks of the 1990s and want some deal.

On the other are the proudly uncompromising junior lawmakers, many of them Tea Party sympathizers, whose ranks were so inflated by Republican gains in the midterm elections. Representative Eric Cantor of Virginia, the House majority leader, has emerged as their standard bearer, debating Mr. Obama in the White House sessions and then boasting of it afterward.

Senator John McCain of Arizona, one of the older generation, reflected the divide in an interview Thursday on Bloomberg TV.

?I think Eric Cantor is carrying out the mandate of last November, which was to stop mortgaging our children?s futures, while the president keeps talking about spending more money,? he said.

Mr. McCain then endorsed, as Mr. Cantor and most House Republicans do not, Mr. McConnell?s proposal to empower Mr. Obama to raise the debt limit through the 2012 elections in three stages, without prior approval of deep spending cuts.

Mr. McCain, mindful of the Republican defeat in a 1995 budget showdown with President Bill Clinton, said the McConnell proposal would absolve Republicans of blame for a default. ?But, it is the last option after we have explored everything else, and, frankly, I hope my colleagues have not forgotten what happened in 1995,? he said.

Republicans say the collisions between Mr. Cantor and Mr. Boehner are indicative of Mr. Cantor?s efforts to stay ahead of potential rivals for the speakership someday in keeping the allegiance of rank-and-file House Republicans.

Mr. Cantor helped torpedo behind-the-scenes discussions between Mr. Boehner and Mr. Obama. But now Mr. Obama, who earlier this year urged Congress to increase the debt limit without a companion measure for long-term budget cuts, has emerged to press for greater deficit reduction than Republicans are.

That is because he demands a ?balanced package? of both spending cuts and tax increases on the wealthy and corporations, while Republicans reject any new tax revenues.

Republicans have shown that their higher priority is not lower deficits, as it was for the party through most of the last century, but a smaller government. House Republicans in the spring passed a plan that would not balance the budget for three decades despite deep cuts in Medicare and Medicaid ? largely because it also deeply cut taxes, adding debt.

For Republicans, ?reducing the deficit implies tax increases, or the possibility of tax increases, and that?s not something they want to do under any circumstances because it doesn?t suit their political needs,? said Stan Collender, a longtime federal budget analyst and a partner at Qorvis Communications.

The party?s dynamic in the debt talks reflects the culmination of a 30-year evolution in Republican thinking, dating to the start of President Ronald Reagan?s administration. The change is from emphasizing balanced budgets ? or at least lower deficits ? to what tax-cutting conservatives have called ?starve the beast,? that is, cut taxes and force government to shrink.

The starve-the-beast philosophy is even more problematic now because the population is aging as baby boomers retire even as medical costs keep rising ? a combination that is driving the projections of an unsustainably growing federal debt.

While the new-generation Republicans venerate Mr. Reagan, those who were in Congress when he was president say he would not understand their refusal to compromise on a package of the size Mr. Obama proposes.

?He had a rule: If you can agree on 80 percent, take it,? said Alan K. Simpson, who was the second-ranking Senate Republican leader back then. ?He raised taxes 11 times in eight years,? Mr. Simpson added. ?He did it to make the country run.?

Almost lost in the tax debate with Republicans is how much Mr. Obama has conceded to them this year on spending cuts, including for those entitlement programs Democrats favor.

?He believes that we have now in front of us the potential to do something big ? the holy grail,? the White House press secretary Jay Carney said.

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Oracle wants Google co-founder to testify in Java patent case

Oracle is hoping it can get Google co-founder and CEO Larry Page to testify in court as it pursues litigation against the search giant for infringing patents related to its Java technology, Reuters reports.

Page is named amongst three other current or former Google employees that Oracle wants to despose in its filing on Thursday, including Dipchand Nishar, a former employee that was behind Google?s mobile initiaties, Bob Lee, a former Senior Software Engineer at Google and Tim Lindholm, an Android software engineer who is said to have contributed to some of the Java code that is being questioned in the suit.

Google is in court having been accused of ?knowingly, directly and repeatedly infringed Oracle?s Java-related intellectual property?. In view of this, the ?lawsuit seeks appropriate remedies?.

FOSSpatent?s Florian Mueller, a technology patent expert, believes Page could be asked to testify by the courts as he was ?involved in Java licensing talks, and Google doesn?t appear to dispute the fact of his involvement?.

The judge presiding over the case has already stated it appears Google knew it was infringing Oracle?s patents and pulled out of negotiations as they become too expensive:

?It appears possible that early on Google recognized that it would infringe patents protecting at least part of Java, entered into negotiations with Sun [Microsystems] to obtain a license for use in Android, then abandoned the negotiations as too expensive, and pushed home with Android without any license at all.?

Google has asked that Oracle CEO Larry Ellison be deposed to answer questions under oath, calling its request a ?harassing demand? because other sources would be able to provide the same information.

The deposing of both Google?s and Oracle?s CEOs could see the case move forward at an increased pace, with it believed the judge could request both executives to testify to put pressure on both parties.

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Source: http://thenextweb.com/google/2011/07/15/oracle-wants-google-co-founder-to-testify-in-java-patent-case/

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Why Is Biomanufacturing So Hard?

Earlier this year, the Cambridge-based biotech firm Genzyme announced the latest in a series of manufacturing delays for Fabrazyme, a biological drug that treats a rare genetic disorder, after one lot of the drug was found to be contaminated. The news followed a more severe setback in 2009, when both Fabrazyme and another drug were contaminated with a virus; the problem closed the manufacturing plant and created major shortages.

Genzyme isn't alone in these issues. Biologics?drugs made through a biological process rather than chemical synthesis, a category that includes recombinant proteins, vaccines, and antibodies?are the fastest-growing segment of the pharmaceutical industry. In 2008, nearly 30 percent of revenue from the top 100 drugs came from biologics, a figure that is expected to rise to 50 percent by 2014.

But the same factors that make biologics powerful drugs also make them a challenge to manufacture. They typically mimic proteins and other molecules found in living organisms and can target harmful entities, such as some cancer cells, with great accuracy; many of the most promising new drugs for cancer and other diseases fall into this class. Biologics tend to be larger, more complex molecules than drugs synthesized through chemical reactions, which adds to production challenges and makes them costly. A single dose of some biologic therapies can cost $10,000.

Biologics are most often produced by cells growing in a bioreactor, a vat designed to maintain carefully calibrated conditions. Because the cells are alive, "every time you run a reactor, the result can be a bit different," says Chris Love, a chemical engineer who is part of MIT's Biomanufacturing Research Program. This inherent variability makes the process both expensive and unpredictable.

Another issue is that for biologics to win approval from regulatory agencies, it's not enough for the drug itself to be approved, as is the case with small-molecule drugs; the manufacturing procedure must be approved as well. While this is important for safety's sake, it also makes it costly to change the production process after it's been approved, and that discourages innovation. "By the time the drug is in the marketplace, you are working with old technology," says Charles Cooney, a chemical engineer at MIT. "You have to lock in the technology many years before launch of a commercial product."

And even when developing experimental drugs, makers tend to stick with methods that have previously been proved safe. As a result, new advances in systems biology and microtechnology have not been integrated into biomanufacturing, says Love.

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Behind Battle Over Debt, a War Over Government

What makes a bipartisan ?grand bargain? so elusive is less the budget numbers, on which compromise could be in reach, than each side?s principles, which do not lend themselves to splitting the difference. President Obama wants deficit reduction, including tax increases for wealthier Americans and corporations. Congressional Republicans, prodded by a cadre of junior lawmakers, want a vastly smaller government constrained by lower taxes. The two are not the same thing.

Mr. Obama will make his case on Friday in a White House news conference, his third in just two weeks.

However this showdown is settled, it seems increasingly likely to define not only the legislative record of this Congress, divided between a Republican-controlled House and a Democratic-controlled Senate, but also the 2012 elections and Mr. Obama?s prospects for a second term.

The two sides met for less than two hours at the White House on Thursday, even as attention appeared to shift away from the prospect of a bipartisan budget agreement to the likelihood of a backup plan to raise the debt ceiling before the Aug. 2 deadline.

Having discussed spending cuts in past White House meetings, the negotiators considered the administration?s proposals for raising taxes, which Republicans have vowed to oppose. Mr. Obama previously had said they would meet again on Friday to decide whether they could reach a deficit-reduction deal; if not, they would spend the weekend negotiating a way to raise the $14.3 trillion debt limit, and defer the bigger budget-cutting clash.

Instead, at the end of Thursday?s session, he told the lawmakers to try to work something out and be ready for his summons to a weekend meeting.

Underlying the budget drama between the White House and Congressional Republicans is another compelling drama among Republicans, which exposes an ideological and generational gap. On one side are older, more senior conservatives like the two top leaders, Speaker John A. Boehner and Senator Mitch McConnell, the minority leader, who remember the budget fights and Republican setbacks of the 1990s and want some deal.

On the other are the proudly uncompromising junior lawmakers, many of them Tea Party sympathizers, whose ranks were so inflated by Republican gains in the midterm elections. Representative Eric Cantor of Virginia, the House majority leader, has emerged as their standard bearer, debating Mr. Obama in the White House sessions and then boasting of it afterward.

Senator John McCain of Arizona, one of the older generation, reflected the divide in an interview Thursday on Bloomberg TV.

?I think Eric Cantor is carrying out the mandate of last November, which was to stop mortgaging our children?s futures, while the president keeps talking about spending more money,? he said.

Mr. McCain then endorsed, as Mr. Cantor and most House Republicans do not, Mr. McConnell?s proposal to empower Mr. Obama to raise the debt limit through the 2012 elections in three stages, without prior approval of deep spending cuts.

Mr. McCain, mindful of the Republican defeat in a 1995 budget showdown with President Bill Clinton, said the McConnell proposal would absolve Republicans of blame for a default. ?But, it is the last option after we have explored everything else, and, frankly, I hope my colleagues have not forgotten what happened in 1995,? he said.

Republicans say the collisions between Mr. Cantor and Mr. Boehner are indicative of Mr. Cantor?s efforts to stay ahead of potential rivals for the speakership someday in keeping the allegiance of rank-and-file House Republicans.

Mr. Cantor helped torpedo behind-the-scenes discussions between Mr. Boehner and Mr. Obama. But now Mr. Obama, who earlier this year urged Congress to increase the debt limit without a companion measure for long-term budget cuts, has emerged to press for greater deficit reduction than Republicans are.

That is because he demands a ?balanced package? of both spending cuts and tax increases on the wealthy and corporations, while Republicans reject any new tax revenues.

Republicans have shown that their higher priority is not lower deficits, as it was for the party through most of the last century, but a smaller government. House Republicans in the spring passed a plan that would not balance the budget for three decades despite deep cuts in Medicare and Medicaid ? largely because it also deeply cut taxes, adding debt.

For Republicans, ?reducing the deficit implies tax increases, or the possibility of tax increases, and that?s not something they want to do under any circumstances because it doesn?t suit their political needs,? said Stan Collender, a longtime federal budget analyst and a partner at Qorvis Communications.

The party?s dynamic in the debt talks reflects the culmination of a 30-year evolution in Republican thinking, dating to the start of President Ronald Reagan?s administration. The change is from emphasizing balanced budgets ? or at least lower deficits ? to what tax-cutting conservatives have called ?starve the beast,? that is, cut taxes and force government to shrink.

The starve-the-beast philosophy is even more problematic now because the population is aging as baby boomers retire even as medical costs keep rising ? a combination that is driving the projections of an unsustainably growing federal debt.

While the new-generation Republicans venerate Mr. Reagan, those who were in Congress when he was president say he would not understand their refusal to compromise on a package of the size Mr. Obama proposes.

?He had a rule: If you can agree on 80 percent, take it,? said Alan K. Simpson, who was the second-ranking Senate Republican leader back then. ?He raised taxes 11 times in eight years,? Mr. Simpson added. ?He did it to make the country run.?

Almost lost in the tax debate with Republicans is how much Mr. Obama has conceded to them this year on spending cuts, including for those entitlement programs Democrats favor.

?He believes that we have now in front of us the potential to do something big ? the holy grail,? the White House press secretary Jay Carney said.

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Google faces second fine over Taiwanese Android app refunds

Google has yet to issue a formal response to the Taipei City Government after officials requested that the search giant amend its app refund policy, meaning Google could be issued with a fine of NT$1 million (US$34,480), its second within three weeks.

Google was warned it could face a fine of at least NT$300,000 (S$12810) from the Taipei City Government back in June, after Smartphone users in the city had complained that they were unable to claim a refund if they deemed an app download as unsatisfactory.

Taipei?s Law and Regulation Commission informed Google Taiwan, as well as Apple Asia, of the complaints in a formal letter, demanding an explanation and an outline of improvements by a June 23 deadline. Apple Asia responded before the deadline and amended its refund policy to comply with Taiwan?s by extending its trial period from 15 minutes to a full seven days. Google did not reply.

Google received its first fine of NT$1 million for failing to heed the warning and subsequently pulled paid Android downloads in the country ? and remain unavailable today.

Following the ban, Taipei City Government officials met with Google?s policy counsel Kenneth Carter to discuss the matter, exchanging ?full and extensive exchange of opinions?. Google was said to be thoroughly understanding of Taiwan?s Consumer Protection Act and rules requiring seven-day trial periods for online sales and was given two weeks to negotiate with officials on the matter.

On Friday, Google said via its lawyer that it would not to follow Taiwan?s consumer protection law to amend the terms of service on the Android Market. Taipei City Government officials have given Google another two weeks to deliberate its decision, allowing them to communicate with the search giant to resolve the issue amicably.

If a decision cannot be made, Google will be issued a second NT$1 million fine.

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Source: http://thenextweb.com/google/2011/07/15/google-set-for-second-fine-over-taiwanese-android-app-refunds/

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Adobe releases Flash 11 beta for Windows, Mac, and Linux (64-bit support!)

Adobe has announced a beta release of Flash Player 11. You can download it directly for Windows, Mac, and Linux.

At the same time, the company has announced the availability of the Adobe AIR 3 beta. You can download it directly for Windows and Mac. Last month, Adobe killed AIR for Linux and announced it would focus on mobile instead.

Adobe says that this first beta is a desktop release, but that it is working hard on a mobile version, which will be coming soon. The company also lists the following features and performance enhancements included in the betas of Flash Player 11 and AIR 3:

  • Captive Runtime for AIR ? this popular feature from AIR for iOS will now be available on AIR for desktop. Simplify the app installation process, reduce testing and certification cost by encapsulating the AIR runtime in your Windows, Mac, andAndroid apps.
  • Native 64-bit support for Flash Player ? take advantage of new 64-bit operating systems and 64-bit Web browsers on Windows, Mac OS, Linux.
  • Stage 3D graphics rendering ? Stage 3D (codenamed Molehill) is a new method of 2D and 3D rendering and is supported with a new Stage3D API. The Stage3D API is a set of low-level GPU-accelerated APIs enabling advanced 2D and 3D capabilities across multiple screens and devices (desktop, mobile, and TV). These new low-level APIs will provide 2D and 3D engine developers the flexibility to leverage GPU hardware acceleration for significant performance gains.
  • H.264/AVC SW Encode for camera encoding ? higher compression efficiency and industry wide support for real-time communications and non-real-time broadcast scenarios, like webcasting, livecasting, etc.
  • Native JSON (JavaScript Object Notation) support ? enables ActionScript programmers to take advantage of fast parsing and generation of JSON-formatted data. Take existing data and integrate it with minimal or no modification into your ActionScript project.

I honestly don't really care about 3D, but I do care about 64-bit support. It's nice to see that the 64-bit Flash preview Adobe offered back in September 2010 is finally being integrated into the main release.

In related news, Adobe has also announced a new public bugbase system (Adobe Bugbase) where you can file bugs and feature requests for both Flash Player and AIR. The new bugbase is a public front end to Adobe's internal bugbase, which will improve tracking, communication, and responsiveness for issues and feature requests. The former bugbase (Adobe Bug and Issue Management System) will remain available as read-only. Adobe is in the process of transferring over all relevant issues and feature requests to the new system.

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Source: http://www.techspot.com/news/44699-adobe-releases-flash-11-beta-for-windows-mac-and-linux-64-bit-support.html

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Hard Lines iPhone Review

Hard Lines iPhone Review

Posted on 26th Jun 2011 at 10:44 by David Hing with 9 comments

Back when mobile phones were still thought of as a new idea, Nokia's 3210 was highly sought after in many circles for its built in version of the highly addictive game Snake. Fast forward a decade, and Hard Lines is attempting to be a worthy successor to that classic title.

The mechanics of Hard Lines are simple. With simple directional strokes of your finger, you steer a line around the screen towards randomly spawning markers, accruing points while avoiding other lines that enter from the sides of the screen.

Slick and neatly designed, Hard Lines is clearly influenced by the Light Cycles from Tron, yet it doesn't limit itself to that one style of play; there are several variations. In some modes, you gain points by getting opposing lines to crash into you or the walls; in others you race against the clock, or just try to last for as long as possible. There are also some good bonuses, such as the occasional power up that enables you to crash through any other competing lines without killing yourself.


The gameplay is occasionally made overly complicated, however, via the addition of dialogue that bikes may utter in the middle of a match. This appears as a single line of text and, while it's often funny, it's usually just a distraction that obscures your view.

Aside from this, though, the balancing is beautiful and the game manages to be both punishing and forgiving at once. Each line is only a single pixel wide, for example, but you only need to pass near an item on the screen to collect it, avoiding any frustrating situations where you might end up circling it forever. Not only this, but the very narrow nature of your line means the game can afford to throw a lot of competing lines at you at any one time. In particular, the Gauntlet mode continually spawns large numbers of other lines rapidly, resulting in an intense session that's highly satisfying when it goes your way.

Verdict: Hard Lines is a well designed, easily controlled, multifaceted version of Snake with enough new material and creativity behind it to stop it being called a straightforward clone.

Hard Lines is available from the AppStore for 59p / 99c.

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Source: http://feedproxy.google.com/~r/bit-tech/blog/~3/AtnThqURR0c/

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Hard Lines iPhone Review

Hard Lines iPhone Review

Posted on 26th Jun 2011 at 10:44 by David Hing with 9 comments

Back when mobile phones were still thought of as a new idea, Nokia's 3210 was highly sought after in many circles for its built in version of the highly addictive game Snake. Fast forward a decade, and Hard Lines is attempting to be a worthy successor to that classic title.

The mechanics of Hard Lines are simple. With simple directional strokes of your finger, you steer a line around the screen towards randomly spawning markers, accruing points while avoiding other lines that enter from the sides of the screen.

Slick and neatly designed, Hard Lines is clearly influenced by the Light Cycles from Tron, yet it doesn't limit itself to that one style of play; there are several variations. In some modes, you gain points by getting opposing lines to crash into you or the walls; in others you race against the clock, or just try to last for as long as possible. There are also some good bonuses, such as the occasional power up that enables you to crash through any other competing lines without killing yourself.


The gameplay is occasionally made overly complicated, however, via the addition of dialogue that bikes may utter in the middle of a match. This appears as a single line of text and, while it's often funny, it's usually just a distraction that obscures your view.

Aside from this, though, the balancing is beautiful and the game manages to be both punishing and forgiving at once. Each line is only a single pixel wide, for example, but you only need to pass near an item on the screen to collect it, avoiding any frustrating situations where you might end up circling it forever. Not only this, but the very narrow nature of your line means the game can afford to throw a lot of competing lines at you at any one time. In particular, the Gauntlet mode continually spawns large numbers of other lines rapidly, resulting in an intense session that's highly satisfying when it goes your way.

Verdict: Hard Lines is a well designed, easily controlled, multifaceted version of Snake with enough new material and creativity behind it to stop it being called a straightforward clone.

Hard Lines is available from the AppStore for 59p / 99c.

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Source: http://feedproxy.google.com/~r/bit-tech/blog/~3/AtnThqURR0c/

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Hardware 25 - What, no Tanks?

Hardware 25 - What, no Tanks?

Posted on 8th Jul 2011 at 14:20 by Paul Goodhead with 11 comments

It's been a while since our last podcast so James, Paul, Antony and Harry had plenty to talk about when they took their seats in the studio this week.

First on the agenda was James and Paul's trip to Computex in Taiwan, where they got to see what the industry had planned for the next six months. Certain things were of particular interest to us though such as the LGA2011 boards being shown at the exhibition.

The other big slice of news that's hit since our last podcast is the launch of AMD's new desktop Lynx processors. The APUs (as AMD calls them) are potentially interesting for those looking for a low cost rig that's also capable of gaming.

Finally, we sneak in a little discussion about Intel's new 50-core maths co-processor card and attempt to answer a reader question about thermal compound.

As always, we've also set up our weekly competition, the lucky winner of which will walk away with a brand new Corsair VX550W PSU.

Hardware 25 - What, no Tanks?

As ever, the bit-tech hardware podcast features music by Brad Sucks, and was recorded on Shure microphones. You can download the podcast direct, listen in-browser or subscribe through iTunes using the links below. Also, be sure to let us know your thoughts about the discussion in the forums.

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