Biosimilar Development insights Documents on Biosimilar Development

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http://www.biosimilardevelopment.com/doc/biosimilar-lessons-from-the-ema-0001 Biosimilar Lessons From The EU - Suzette Kox, the senior director of the Biosimilars Medicines Group and chair of the biosimilars committee of the International Generic and...

http://www.biosimilardevelopment.com/doc/trends-that-will-carry-genomics-into-and-beyond-0001 9 Trends That Will Carry Genomics Into 2020 (And Beyond) - Remarkable advances in genomics technologies bring the promise of extraordinary changes in healthcare — and some of those changes are arriving...

http://www.biosimilardevelopment.com/doc/to-see-the-biosimilar-future-look-to-the-past-0001 To See The Biosimilar Future Look To The Past - According to GPhA CEO Chip Davis, today’s politically charged atmosphere poses great risks for biosimilar uptake. But the past may hold some...

http://www.biosimilardevelopment.com/doc/the-healthcare-purchaser-s-role-in-biosimilar-uptake-0001 The Healthcare Purchaser’s Role In Biosimilar Uptake - Small molecule generics were a game changer for healthcare purchasers, like OPERS. Now, as biosimilars arrive on the market, purchasers are faced...

http://www.biosimilardevelopment.com/doc/utility-system-design-considerations-for-single-use-bioprocessing-0001 Utility System Design Considerations For Single-Use Bioprocessing - Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic...

http://www.biosimilardevelopment.com/doc/for-u-s-biosimilar-success-look-beyond-borders-0001 For US Biosimilar Success Look Beyond Borders - In any industry, there are the experts who become known as the foremost voices of the industry. Biosimilar evangelist, Bert Liang, CEO of Pfenex and...

http://www.biosimilardevelopment.com/doc/quality-systems-basic-concepts-considerations-0001 Quality Systems 101 Basic Concepts Considerations - Whether you are a life science startup with a brick-and-mortar office or working as a virtual company, at some point the question comes up: Do we...

http://www.biosimilardevelopment.com/doc/biosimilar-battles-at-the-state-level-0001 Biosimilar Battles At The State Level - While Express Scripts' Jonah Houts thought working on federal law, specifically the Biologics Price Competition and Innovation Act (BPCIA), was...

http://www.biosimilardevelopment.com/doc/what-recent-fda-enforcement-actions-in-the-eu-mean-for-fda-ema-cooperation-0001 What Recent FDA Enforcement Actions In The EU Mean For FDAEMA Cooperation - FDA and the EU have taken serious enforcement actions against firms in the other’s geographic jurisdiction during the calendar year 2016. In...

http://www.biosimilardevelopment.com/doc/taking-the-first-step-in-six-sigma-an-overview-of-the-define-stage-0001 Taking The First Step In Six Sigma An Overview Of The “Define” Stage - In my previous article, I broadly introduced the Six Sigma approach to process excellence, along with some examples of its application and a...

http://www.biosimilardevelopment.com/doc/the-biosimilar-playbook-market-realities-manufacturers-must-know-0001 The Biosimilar Playbook 4 Market Realities Manufacturers Must Know - Throughout an expansive presentation about the biosimilar market’s progression, Sanford Bernstein analyst Ronny Gal homed in on four topics I...

http://www.biosimilardevelopment.com/doc/overcoming-the-barriers-to-global-biosimilar-adoption-0001 Overcoming The Barriers To Global Biosimilar Adoption - In the coming years, prudent policymaking will be necessary to expand biosimilar volumes and provide patients with greater access to these...

http://www.biosimilardevelopment.com/doc/fda-emphasizes-regulatory-flexibility-in-biosimilar-reviews-0001 FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews - A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where ...

http://www.biosimilardevelopment.com/doc/adc-manufacturing-challenges-you-need-to-know-0001 5 ADC Manufacturing Challenges You Need To Know - The unique targeting capabilities and promising clinical trial results of antibody-drug conjugates (ADCs) have made them an exciting and promising...

http://www.biosimilardevelopment.com/doc/from-discovery-to-development-gs-expression-system-for-next-generation-biologics-0001 From Discovery To Development GS Expression System For Next-Generation Biologics - Compared to traditional antibody expression, where routine purification and analytical strategies have been established over the last few years,...

http://www.biosimilardevelopment.com/doc/digging-into-the-details-commonly-asked-questions-about-lonza-s-xs-and-gs-expression-systems-0001 Digging Into The Details: Commonly Asked Questions About Lonza’s XS And GS Expression Systems - No single strain or vector is capable of being the best expression option for all types of biopharmaceuticals. Experts from Lonza answers questions...

http://www.biosimilardevelopment.com/doc/three-ways-to-maximize-post-marketing-research-for-biosimilars-0001 Three Ways To Maximize Post Marketing Research For Biosimilars - Proving therapeutic equivalence is an important step in the approval process for a biosimilar. The research needed is time, labor and resource...

http://www.biosimilardevelopment.com/doc/perspectives-on-the-future-of-drug-development-and-delivery-0001 Perspectives On The Future Of Drug Development And Delivery - The pharmaceutical industry is moving faster than ever before, continually evolving to meet the changing and growing needs of patients around the...

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ScooterPK - 6 hours and spa leak stopped

2 years ago I found an excellent 8 man hot tub on Craigslist for 'free' (insert sarcasm). After $1000 worth of repairs (new motors, plumbing and a cover) it was functional. The tub retails for around 7k so I figured my labor had paid off. A slight leak has been plaguing it ever since I got it running. I searched all kinds of remedies and found this product a few months ago. I figured it was worth a shot. My tub hold around 500 gallons. I first removed the filters which I was leery about and ran the tub. I added 12 oz of the fix a leak to the tub through the skimmer. I then went out every hour or so and kicked on the blowers and motors to keep the fix a leak suspended in the water. within 6 hours the wet areas on the cement pad had started to dry up and the wet spots in the yard where it ran off had also stopped holding a puddle. Today, the sun came out and was warm and the leak has stopped or has significantly been plugged. I will wait to see how it holds but early indications are that this stuff works. I have installed the filters back into the system and am filtering out the remaining fix a leak. I'll drain it, scrub down the tub and fill it up just in time for the fall and winter season. Highly recommended. I'll follow up in a few weeks to see if this holds.

Ella age 6 - Check you're dad's eyes for x Ray vision.

Is your dad stronger than a rhino ? Is he faster than a bullet? Can he hear you even when you 're silent as a mouse? If you don't believe your dad can do that, read this book!

Dan Rogers - Not the supply chain bible, but a good read that makes you think.

The goal, and Goldratt's revolutionary thinking for the time make this a must read if you run a factory, a supply chain, or any other kind of multi-person process that would benefit from higher quality and shorter throughput times. I love how he makes me think about things like total spend in addition to unit cost. A real eye opener, convincingly done. If you get this, do think about his other books to back up and fill in some of the execution elements of his theories. Long may he rest in peace - he helped me solve some hard problems.

frankliana - ... at Aquatica for over 5 hours and it worked great. The only negative I can say in general ...

I finally used the case at Aquatica for over 5 hours and it worked great. The only negative I can say in general is that it is hard to touch the screen when your hands are wet and the outside of case is too. I recommend purchasing this case to everyone plus it comes with the necklace that makes it easy to hold. We went on water rides, wave pools and water slides are never did i have a problem. Great buy!