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Articles by Mike Brewer
Ensure The Safety And Purity Of Your Cell Therapy Product With Mycoplasma And Sterility Testing
Get more Cell & Gene insight with our FREE newsletter By Mike Brewer and Sharon Rouw See the latest innovations in mycoplasma and sterility testing for biopharma. This new application note illustrates how these streamlined workflows and rapid turnarounds can increase efficiency and support faster delivery of life-saving therapeutics to patients.
Ensure The Safety And Purity Of Your Cell Therapy Product With Mycoplasma And Sterility Testing
By Mike Brewer and Sharon Rouw See the latest innovations in mycoplasma and sterility testing for biopharma. This new application note illustrates how these streamlined workflows and rapid turnarounds can increase efficiency and support faster delivery of life-saving therapeutics to patients. Discover how the Applied Biosystems™ MycoSEQ™ Plus system and Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing System can help accelerate your cell therapy manufacturing process.
Addressing regulatory guidance for HEK293 cells and AAV-based therapeutics manufacturing
Cell & Gene Therapy Insights 2023; 9(11), 1403 DOI: 10.18609/cgti.2023.182 Characterization of a biological product’s identity and potency via analytical assays is necessary to allow for relevant specifications to be established. However, there are a number of regulatory hurdles associated with the development and validation of these analytical assays.
How 911 innovations improve dispatchers’ lives and keep communities safe
When emergency strikes—car accidents, break-ins, domestic disputes, cardiac arrest, the list goes on—communities rely on their 911 dispatchers to quickly answer the call, assess the situation and send first responder teams to help. But how does this high-pressure job impact the lives of those dispatchers on the other end of the phone? Emergency services dispatchers are “always on” during their 10-12-hour shifts, which can easily extend to 16 hours depending on staffing shortages.
Lady Eagles make first appearance in UIL State Basketball Tournament
Subhead Hearne Lady Eagles Sports The Hearne Eagle girls basketball team made program history last Thursday morning inside the Alamodome in San Antonio when they made their first appearance in the UIL State Basketball Tournament. Hearne was matched up against the defending Class 2A State Champion Gruver Lady Hounds in the semi-final. Gruver was making its fifth tournament appearance, including championships in 2020 and 2022.
Mycoplasma testing: regulatory guidance and strategies for cGMP cell and gene therapy manufacturing
Cell & Gene Therapy 2022; 8(11), 1501 DOI: 10.18609/cgti.2022.220 Mike Brewer Mycoplasma, the smallest known free-living, self-replicating microorganisms, are potential contaminants of mammalian cell cultures, including biotherapeutic manufacturing cell cultures. As such, these cultures must be tested and are required to be free of Mycoplasma.
Franklin pulls away to beat the Hitchcock Bulldogs 53-18
Subhead Franklin Lion’s Football Lions will face Columbus Friday at 7:00 in Region 3 finals dvocate The Franklin Lions continued their incredible three-year run last Friday night when they ran past the Hitchcock Bulldogs 53-18 at Woodforest Bank Stadium in Shenandoah. With the win, Franklin improved to 13-0 on the season and has now won 29 straight games.
Lions host the Troy Trojans Friday in District 11-3A match-up
Subhead Franklin Lions Football The Franklin Lions will continue the District 11-3A portion of their schedule when they host the Troy Trojans Friday night following their bye week last Friday. Franklin (6-0, 2-0) used the bye week to heal some nagging injuries and get ready for the remainder of the 2022 district schedule. “We were glad to have the bye week come when it did,” said Franklin head coach Mark Fannin.
Lions celebrate Homecoming with 69-32 win over McGregor
Subhead Franklin Football and Homecoming The No. 1 ranked Franklin Lions celebrated Homecoming Friday night with a convincing 69-32 win over the McGregor Bulldogs in front of a packed home crowd at Hedrick Field. Senior Hailey Fannin was named the 2022 Homecoming queen at halftime as the Lions opened the District 11-3A play portion of their schedule.
Frankiln Football outs duels Diboll 35-23 to remain uundefeated
Subhead games. The top ranked Franklin Lions remained undefeated on the young season last Friday night with a hard-fought 35-23 win over the Diboll Lumberjacks at Hedrick Field. With the win, Franklin improved to 3-0 against a competitive non-district slate.
Residual DNA testing in viral vector manufacture: exploring the challenges and solutions
Ilaria Scarfone (left), Field Application Specialist, Pharma Analytics, Thermo Fisher Scientific speaks to Mike Brewer, Director and Global Principal Consultant, BioProduction Division, Thermo Fisher Scientific Q IS: Mike, to begin, could you give a brief introduction and background on the residual DNA testing regulatory requirements in general, and why gene therapy products present some particular challenges?
FRANKLIN LIONS STATE CHAMPIONS
Subhead LIONS 49 - Gunter - 35 • 3A Division II • Thursday, December 16. 2021 • AT&T Stadium, Dallas, Texas Hannah White Photgraphy | Franklin Advocate Franklin sophomore linebacker Colby Smith with the Defense MVP, with 11 tackles and 1 interception. Malcoln Murphy, a senior ran 282 yards on 15 carriers with 4TD to earn the Offense MVP Award. Jan Roe | Franklin Advocate Sr Haze Tomascik (31) stuffs the Gunter Punter/QB on their 10 yard line to set up a Bryson Washington score 3 plays later.
Franklin defeats Waskom 28-14 in state semifinals
Subhead Lions headed back to AT&T Stadium in search of their title Franklin defeats Waskom 28-14 in state semifinals Last season the Franklin Lion football team rallied around the phase “164”. That is the mileage between Hedrick Field and AT&T Stadium, the site of the UIL State Championships. The Lions made it to the 2020 title game where they lost a one-point thriller to Canadian. This season the team’s rally cry is simply “Finish”.
Top ranked Franklin dominates Poth 66-0 to advance to State semi-finals against Waskom
#8 Devin Hidrogo steals a Pirate pass in the end zone for a touchback and Franklin possession. Jan Roe | Franklin Advocate When Franklin entered its Class 3A Division II quarterfinal game with Poth, most football observers believed the Pirates would be the best defense the Lions had faced all season. The Franklin offense proved the experts wrong, scoring nine touchdowns and a field goal on its ten possessions en route to a 66-0 thrashing of the Pirates.
No. 1 ranked Lions roll past Riesel 60-0 to advance to Region 4 finals
The Lions played a dominating game against the Riesel Indians, causing the Lions to move on in District competition. Hannah White | Franklin Advocate The old saying that it is hard to beat the same team twice in one season was not the case last Friday night when the top-ranked Franklin Lions shut out the Riesel Indians 60-0 in the UIL state playoffs.
Lions open playoffs with 63-7 win over Danbury
The Franklin Lions show their support for Veterans as they take the field on November 11 against the Danbury Panthers. HANNAH WHITE | FRANKLIN ADVOCATE The Franklin Lions opened the 2021 UIL football playoffs Thursday night when they dismantled the Danbury Panthers 63-7 at Waller ISD Stadium. The top-ranked Lions, coming off a bye week, scored on all nine of their offensive possessions before kneeling on the final three plays of the game.
No. 1 ranked Lions open football playoffs against Danbury
A photo of the Lion’s entering the field, taken during their game against Riesel. HANNAH WHITE | FRANKLIN ADVOCATE The Franklin Lions will begin their quest for a another trip to AT&T Stadium when they face the Danbury Panthers Thursday night at 7:30 at Waller ISD Stadium. The Lions will be looking for their third trip to the state championship game in seven years when they face the fourth-seeded Panthers out of District 14-3A.
Lions finish district play undefeated with a 57-0 shutout of Clifton
Malcom Murphy and Hayden Helton celebrate after one of the consecutive touchdowns against Clifton. HANNAH WHITE | FRANKLIN ADVOCATE The Franklin Lions wrapped up the District 13-3A portion of their schedule last Friday night when they dominated the Clifton Cubs 57-0 at Hedrick Field. With the win, the Lions moved to 10-0 on the season, including a perfect 6-0 slate in league play where they outscored their district foes 387-41.
11.04.21 -- Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd. While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices. Article | By Joe Hoff, Automated Systems of Tacoma, Inc.
Lions crush Buffalo 77-3 to remain undefeated
The Franklin Defense put up an impressive display against the Buffalo Bison’s, keeping their score at a major low. HANNAH WHITE | FRANKLIN ADVOCATE The No.1 ranked Lions remained undefeated (9- 0, 5-0) Friday night when they manhandled Buffalo 77-3 at Bison Stadium. The Franklin defense set the tone on the Bison’s first possession of the game when it stopped Buffalo on a fourth-and-two at their own 37-yard line.
Lions celebrate Homecoming with a 73-6 win over Florence
When the center gets to be a part of the touchdown celebration, IT’S GAME DAY!! HANNAH WHITE | FRANKLIN ADVOCATE The Franklin Lions continued their dominance over District 13- 3A last Friday night when they destroyed the Florence Buffaloes 73-6 in front of a packed 2021 homecoming crowd. The Lions wasted no time getting on the scoreboard when Bobby Washington returned the opening kickoff 81 yards for a 6-0 lead just 16 seconds into the game.
Lions throttle Rogers 56-7 in District 13-3A action
Freshman Jayden Jackson (1) blasted out of the Lions backfield, broke a tackle, lost a shoe and still scored from 84 yards out late in the contest against Rogers. Jackson and brother SR Malcolm Murphy combined to add 228 yards to the Lions ground game. Jan Roe | Franklin Advocate The Franklin Lions carried their No. 1 ranking on the road last Friday to face District 13- 3A co-leader Rogers in a first place showdown.
Franklin football team stays perfect with 75-13 win over Riesel
#70 Russell Stegall going for a field goal kick during the Franklin vs. Riesel game. Hannah White | Franklin Advocate Top ranked Franklin continued its perfect football season last Friday night when they shredded the Riesel Indians 75- 13 at Hedrick Field. After forcing a three-and-out on Riesel’s first possession, the Lion offense took over at the 10- yard line following a nice punt return by Malcolm Murphy.
Lion football team throttles Lexington 49-12 to open district play
Parker Boyett goes in for a tackle, keeping Lexington at bay during the football game. HANNAH WHITE PHOTOGRAPHY | FRANKLIN ADVOCATE The Franklin Lions continued to run through the competition last Friday night when they opened District 13-3A play with a convincing 49-12 win over the Lexington Eagles. The Lion offense had three different backs run for over 100 yards as they racked up 438 yards rushing on the Lexington defense.
Franklin Sports
Ethan Saxon rushes down the field, scoring the Franklin Lions another touchdown. HANNAH WHITE | FRANKLIN ADVOCATE The No. 1 ranked Lion football team scored early and often last Friday night when they dominated the Troy Trojans 65-10 in their final non-district tune up of the season. Franklin scored 19 points in the first three and a half minutes to take control of the game early. “That was a really crazy start for us,” said Franklin head football coach Mark Fannin.
Lions run through Cameron in 41-21 non-district win
Sr. Bobby Washington (12) pounded out 135 yards rushing on 18 carries against Cameron including this 17 yd touchdown run in the 4th quarter. JAN ROE | FRANKLIN ADVOCATE The top-ranked Franklin Lions continued their run through the non-district portion of the 2021 schedule Friday night with a convincing 41-21 win over Cameron in front of a packed house at Yoe Field.
Franklin football team honors fallen heroes during Highway 79 Showdown win over Eagles
The Franklin Lion’s charge out of the gates, holding 13 flags for the 13 recent fallen soldiers in Afghanistan. HANNAH WHITE | FRANKLIN ADVOCATE The Franklin Lions squared off with the Hearne Eagles Friday night for the 69th edition of the Highway 79 Showdown. Before the game, the Lions honored the 13 fallen service members who died during the evacuation of Afghanistan with flags on 13 chairs below the scoreboard.
Leopards fall prey to Lions: Leopards now extinct
With Lorena driving and 35 seconds on the clock, Sr. Parker Boyett stripped the ball and Soph Brayden Youree (2) turned out the lights on the Leopards with this fumble recovery and celebration. SUBMITTED PHOTO | ROBERTSON COUNTY NEWS Sophomore sensation Bryson Washington (15) blows through defenders for a 49 yard Franklin touchdown in the 4th quarter. Washington rushed for 200 yards on 14 carries and 2 rushing touchdowns.
Residual Host Cell DNA Quantitation: Evaluating In-House Vs. Commercial Solutions
By Mike Brewer & Karen Salomon The need for speed in biologics development is greater than it has ever been. Regardless of the modality or therapeutic class, there are often multiple companies racing to develop, manufacture, and commercialize high-quality products to be the first-in-class therapeutic. However, there are many manufacturing and analytical challenges that a company can face as it strives to be the first to market.
Residual Host Cell DNA Quantitation: Evaluating In-House Vs. Commercial Solutions
By Mike Brewer & Karen Salomon The need for speed in biologics development is greater than it has ever been. Regardless of the modality or therapeutic class, there are often multiple companies racing to develop, manufacture, and commercialize high-quality products to be the first-in-class therapeutic. However, there are many manufacturing and analytical challenges that a company can face as it strives to be the first to market.
Residual Host Cell DNA Quantitation: Evaluating In-House Vs. Commercial Solutions
By Mike Brewer & Karen Salomon The need for speed in biologics development is greater than it has ever been. Regardless of the modality or therapeutic class, there are often multiple companies racing to develop, manufacture, and commercialize high-quality products to be the first-in-class therapeutic. However, there are many manufacturing and analytical challenges that a company can face as it strives to be the first to market.
Black Lives Matter Beliefs, Agenda Exposed
4:00PM EDT 8/3/2020 Mike Brewer (Unsplash/Clay Banks) Black Lives Matter's shocking beliefs and agenda have now been exposed. Taken directly from the organization's website, here are a few of the disturbing beliefs we are discussing on a recent episode of the Aposotlic Perspectives podcast on the Charisma Podcast Network: "We make space for transgender brothers and sisters ... do the work required to dismantle cisgender privilege and uplift Black trans folk ...
Controversial Activist Gets Christian Nurse Suspended
2:12PM EDT 7/15/2020 Mike Brewer How will you respond when they require your silence? (Unsplash/Jan Vasek) Is this nurse under fire by a Marxist agenda? How will you respond when they require your silence? Unfortunately, many will be making the choice to be quiet or get fired. This nurse, who is a strong Christian, refuses to comply with the pressure of silence. Is it possible that there are activists out there seeking an opportunity to get you fired over your values and viewpoints?
#apartmenthackers
#apartmenthackers, by Mike Brewer: updated automatically with a curated selection of articles, blog posts, videos and photos. Please enable Javascript to correctly display the content on Paper.li
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