Quick Hits: Roche Increases COVID-19 Antibody Test Output

The FDA granted emergency approval for the antibody test that determines whether people have been infected with coronavirus.

May 4th, 2020

Roche

Reuters

Wondering if you’d had COVID-19? Join the club. Luckily, the test that determines if you’ve been infected is about to become a lot more accessible. A recent Reuters article noted that the FDA just granted emergency approval for Roche’s antibody test. The Swiss drugmaker hopes to more than double production to make over 100 million tests a month by the end of 2020.

The antibody test has a specificity rate that exceeds 99.8% and a sensitivity of 100%, which means it generates very few positive results, and no false negatives. Roche also makes a molecular test that identifies active COVID-19 infections.

The combination of Flexi-Cap and Booklet-Label blinds the vial and offers ample space for product information in several languages.

CSL Behring Uses Specialty Label System to Blind Vials for Clinical Trials

There are visible differences between the candidate and the placebo in this international Phase III trial. The blinding system combines a cap system that completely covers the vial with a booklet label for multilingual product information.

Getty Images 1062903070

Robotics Solutions Future Looks Bright

The demand for cobots will continue to grow, and robotics will expand outside of end-of-line applications, according to a new report by PMMI Business Intelligence.

Alignment 90 Sep Oct 2018

Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM)

The Agency is soliciting feedback from manufacturers on assessing and rewarding QMM through Oct. 2020. Reduced audit frequency may one day be an incentive for high performers.

New web-based PMMI Media Group event will bring the packaging and processing industry together, virtually.

Register Now for First of Its Kind PACK EXPO Connects

The new web-based PMMI Media Group event will bring the packaging and processing industry together, virtually Nov. 9-13.

Pharma Packaging Trends Webinar (1)

Pharma Packaging Innovations

New webinar covers several unique packaging innovations to overcome challenges such as child resistance/senior friendly, on-the-go convenience, anti-counterfeiting and improved packaging functionality.

Getty Images 180405693

IIoT Blind Spots: Where are They and Do You Have Them?

A crucial component of automation advancement, yet one that is lacking at most manufacturers, is the deployment of IIoT connectivity across an entire enterprise, including key areas such as receiving, warehousing, and shipping.

Getty Images 1127072463 5e7a15be2627a

Poseidon: Call to Participate in Pre-Commercial Ocean Freight Trials

COVID-19 immunization will need a staggering collaborative effort in intercontinental transportation. Pharmaceutical manufacturers are invited to register their interest in participating in the final Poseidon trials.

Automation Timeline 5 1

Moving Automation Up the Line

According to a new report by PMMI Business Intelligence, OEMs and suppliers should assist manufacturers to identify new automation projects that lie outside the traditional end-of-line packaging and palletizing.

Screen Shot 2020 08 07 At 10 44 39 Am

Variable Barcodes to Boost COVID-19 Test Kit Experience

Scannable point of care tests were designed to increase test accuracy, collect data, and take the guesswork out of reading results.

U.K. Corner-Shop Favorite Rejuvenated

Contemporary new graphics that focus on the unique taste of milk-based nutrition brand Nurishment along with a new bottle format are designed to appeal to larger consumer base.

“Another key [UDI] benefit, because we're calling that product by the same name across the healthcare supply chain… rich and robust data that we can access around supply consumption and utilization rates. One of the buzz terms we've heard during the COVID-19 crisis was what's my burn rate? How fast am I going through gowns, masks, gloves?” – Mike Schiller, Senior Director at AHRMM

Quotables and By the Numbers: Aug. 2020

Climate, packaging, medical device security, and more.

Getty Images Global Supply Chain (1)

The Pandemic is Shaping the Future Supply Chain

Some of the greatest innovations happen during times of disruption.

Early indications reveal industrywide interest on new web-based event.

Early Industry Enthusiasm Builds for PACK EXPO Connects

The packaging industry appears poised to embrace newly launched wed-based event.

3 C90649 D D421 464 F 9 Fe1 906 A73 A2 Bc7 F

Small Batch Skin- and Haircare Line Offers Glass Packaging on a Budget

After making the switch from a career in occupational therapy, a former hand specialist offers a variety of personal care products with cruelty-free, natural ingredients in recyclable packaging.

Festo Life Sciences Plant

Compressed Air Measurement Helps Reduce Energy Use

Installing Festo’s E2M energy efficiency modules helped medical device and pharmaceutical manufacturers tackle their environmental footprint, not only saving money but using the data to provide predictive maintenance as well.

In the men's skincare market, the demand for cleanser, face wash, and sunscreen products is outpacing that of shave care essentials, according to a new report from Grand View Research, Inc.

Packaging Will Help Drive Men’s Skincare Product Market

Premium products with organic and natural ingredients are the latest trend, resulting in the growing popularity of more sustainably sourced packaging materials.

Automation Timeline 1

Five Takeaways on Automation Growth Today

A new report by PMMI Business Intelligence shows that OEMs and suppliers who meet the needs of the changing times will thrive along with the CPGs of the future.

I Stock 000086136291 Medium 2

Survey Reveals Biopharma Companies’ Focus on Sustainability in Cold Chain Partnerships

Results note that sustainability is moving from a nice-to-have to a must-have, putting sustainable temperature-controlled shippers in high demand.

Susosu mineral water infused with molecular hydrogen is packaged in a 300-mL multilayer aluminum pouch with gussets.

Hydrogen Water Potency Preserved with Aluminum Pouch

Unique gusseted aluminum stand-up pouch format keeps hydrogen atoms inside, preserving the antioxidant, energy-boosting, and anti-inflammation properties of the water.

Corning developed Valor Glass for vials designed to be more resistant to damage than conventional glass.

Study: Automatic Inspection for Lyophilized Drug Products in Valor Vials

Companies partnered to test whether the new vial material would present obstacles to proper inspection for pharmaceutical manufacturers.

More in Home

Screen Shot 2020 07 31 At 12 42 00 Pm

HCP Editors Talk: COVID-19 and Manufacturing

In this episode, we discuss concerns about cybersecurity, disaster prep, and using automation to work toward manufacturing a vaccine.

Medical Vials Cold Chain

ISTA Pharma Committee Virtual Roundtable Discussions: Aug. 11 and 25

As a follow up to the open meeting held in June, the ISTA Pharma Committee will host two roundtable discussions in August to discuss in-depth the top two topics of interest from the industry survey.

Pandemic Cancels In-Person PACK EXPO International

PMMI Media Group launches new live, web-based event: PACK EXPO Connects 2020.

FDA Guidance: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

A new 4-page guidance from FDA comes on the heels of an increase in repackaging drugs for administration as a single dose.

Getty Images Resized

Hand Sanitizer Spike Here to Stay

U.K. co-packers’ association reports that inquiries for personal care items rocketed by more than 500% shortly after the coronavirus lockdown was implemented.

Monique Sprueill of Johnson & Johnson addresses supply chain management for ATMPs.

Innovative Therapies Demand Data and Risk Management in Supply Chain

Gene and cell therapies delivered to patients struggling for their lives further complicate an already complicated supply chain. Data and analytics throughout the process are essential to maintaining the integrity needed.

Screen Shot 2020 07 28 At 2 44 16 Pm

2020 Healthcare Package Design Gallery

Months and years go into designing an over-the-counter package to ensure the consumer can safely use it, often in mere seconds.

The Cobot Expo will take place online July 28-30.

Cobot Deployment Shines in COVID-19 Pandemic

Leading up to its virtual Cobot Expo this week, Universal Robots highlighted several cases where small companies have been using collaborative automation to keep production going amid the crisis.

The future of manufacturing can't be imagined in a present-forward mindset. Innovation comes from the future-back.

Reverse Engineering the Organization

A new book reveals how “future-back” thinking—defining what the company will look like decades from now and working backwards—can encourage innovative ideas that will create breakthrough growth.

Study Evaluates Benefits of Atmosphere Control in Blisters

Companies partnered to (1) compare the efficacy of Activ-Blister packaging configurations with cold-form foil in maintaining the stability of a model tableted drug product and (2) compare results to an Accelerated Stability Assessment Program study.

Climate Change Interest Isn’t Ideology, It’s Economics

Economics is the new driver of climate change initiatives, according to Reusable Packaging Association. Attention to packaging selection and management can not only help reduce negative sustainability impacts, but also create new value streams.

Med Devices and the FDA: Extended Deadline, Worker Safety

In extending UDI compliance dates for low-risk products, FDA cited challenges related to COVID-19. CDRH also issued recommendations for personnel safety in med device manufacturing.