Pharmaceutical Processing World Archives - Page 39 of 64

BICO’s Scienion and Cellenion launch SpheroOne large-particle sorter and dispenser

The SpheroOne large-particle sorter and dispenser (Photo courtesy of BICO Group]

BICO Group subsidiaries Scienion and Cellenion today announced the launch of their SpheroOne single large-particle sorter and dispenser for drug testing using complex in-vitro 3D models.

The SpheroOne platform can dispense individual spheroids, organoids and tumoroids, handling cellular aggregates ranging from 80 µm to 600 µm and complementing Cellenion’s CellenOne platform for sorting and dispensing single cells (ranging from 0.5 µm to 80 µm), the companies said in a news release.

“Current offerings suffer from low throughput, inconsistent sorting and intensive manual dispensing,” Cellenion founder and Managing Director Guilhem Tourniaire said in the news release. “SpheroOne is going to play a significant role toward replacing animal models in pre-clinical research as it allows automated sorting, enables development of h…

Avatour sees traction for 360° remote site meetings in pharma and beyond

Avatour technology in use at a Seqens facility

While COVID-19 has led to an uptick in remote inspections and virtual training, the startup Avatour (San Francisco) was working on its remote presence platform before the pandemic.

Devon Copley, CEO of the company, was the head of product, VR platform for Nokia from 2015 to 2017, where he was involved in creating a novel Nokia OZO 360° camera. “That was a $60,000 device made out of a single block of CNC-machined aluminum,” Copley recalled. “It was a beautiful piece of engineering, but a little ahead of its time, as it turned out.”

After Nokia decided to cancel the project, Copley reached out to Prasad Balasubramanian, who was in charge of the engineering team for the OZO advanced camera.

Over beers, the two concluded that the concept of enabling individuals to remotely visit a location and talk to individuals there in real-t…

Advanced Energy debuts new mobile app version for streaming critical temperature data

Advanced Energy (NSDQ:AEIS) has introduced the TEGAMLink T2.0 mobile app, which works with the company’s TEGAM 930 Series Bluetooth thermometers for pharmaceutical and food safety applications.

The app supports the streaming and recording of temperature data from production-floor equipment to programs and quality management systems. A Touch Entry keyboard extension supports automation capability for companies with smart manufacturing implementations. The keyboard extension permits pharmaceutical companies to enter temperature data into form fields, documents, spreadsheets and quality management systems without modifying hardware or software.

Advanced Energy notes that the app eliminates the need for manual temperature data collection and measurement.

The app (shown below with the 932B datalogging thermometer), which is completely redesigned for its second version, is available for both Android and iOS devices.

CDC authorizes fourth COVID-19 vaccine dose for some immunocompromised patients

As a growing number of Americans become eligible for a third dose of COVID-19 vaccines, CDC continues to expand its booster guidelines.

The agency has amended its criteria for moderately to severely immunocompromised people to allow a fourth dose of COVID-19 vaccine six months after receiving the third dose.

The criteria pertain to immunocompromised individuals who are 18 years of age or older who have received three doses of an mRNA vaccine.

CDC will allow COVID-19 vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX), Moderna (NSDQ:MRNA) or Janssen (NYSE:JNJ) for the fourth dose. For Moderna recipients, the guidance recommends a 100-µg dose of mRNA for the third dose and a 50-µg dose for the fourth.

The guidelines, however, are more overt in their recommendations for moderately or severely immunocompromised individuals who have only received two doses of an mRNA vaccine. Assuming at least 28 days have elapsed since the second dose, CDC recommends t…

Lilly beats Street in Q3, raises guidance on COVID-19 antibody revenues

Eli Lilly (NYSE:LLY) shares slightly dipped today on third-quarter results that topped the consensus forecast.

The Indianapolis-based company posted profits of $1.1 billion, or $1.22 per share, on sales of $6.8 billion for the three months ended Sept. 30, 2021, for a -8.1% bottom-line slide on sales growth of 18%.

Adjusted to exclude one-time items, earnings per share were $1.94, 26¢ ahead of Wall Street, where analysts were looking for sales of $5.7 billion.

“Lilly demonstrated strong performance again this quarter. Revenue attributable to our newer medicines grew more than 35 percent and represented nearly 60 percent of our core business, an important indicator of our long-term growth potential,” Lilly Chairman & CEO David A. Ricks said in a news release. “With numerous positive pipeline events this quarter, we have the potential to continue to expand the number of patients we serve through new indications for both Verzenio and Ja…

PerkinElmer launches cloud-based research suite for pharmaceutical customers

PerkinElmer (NYSE:PKI) announced today that it launched the Signals Research suite for both pharmaceutical and industrial customers.

Waltham, Massachusetts-based PerkinElmer’s full cloud-based Signals Research suite, deployed on Amazon Web Services (AWS) offers a secure informatics platform with integrated, end-to-end scientific data and workflow management for pharmaceutical and industrial customers.

PerkinElmer designed the platform to help drive more informed and accelerated decision making around drug, compound and formulation candidates through PerkinElmer’s informatics technologies, according to a news release. Multi-discipline R&D teams can unify critical experiment and testing data, better configure and control workflows and more effectively and efficiently manage critical scientific results, the company said.

The platform combines PerkinElmer Informatics’ Signals Notebook electronic lab notebook with the Signals VitroVivo d…

China begins administering COVID-19 vaccines to children as young as 3

In China, roughly 80% of the population is vaccinated against COVID-19.

The country, along with Cuba, is also among the first to begin vaccinating young children. At least five out of 23 provinces have started administering shots to children aged three to 11.

China plans on hosting the 2022 Winter Olympics from February 4–20, 2022, in Beijing and the surrounding Hebei.

China is not allowing foreign spectators to attend the event.

The International Olympic Committee is also requiring that athletes, team staff and journalists who travel to Beijing for the Olympics be fully vaccinated or face a 21-day quarantine. In addition, attendees will also undergo mandatory daily PCR testing.

China has authorized vaccines from Sinopharm (HKG:1099) and Sinovac for children as young as three, but, to date, it has only vaccinated children 12 and up until recently.

In the West, the U.S. and several countries in Europe have authorized COVID-19 vaccines…

Novartis to continue manufacturing Pfizer/BioNTech vaccine

Novartis (NYSE:NVS) has announced that it has reached an agreement with BioNTech (NSDQ:BNTX) and Pfizer (NYSE:PFE) to produce their popular COVID-19 BNT162b2 vaccine.

The companies reached a new production agreement that will leave Novartis responsible for fill-and-finish operations related to the mRNA-based vaccine from Pfizer and BioNTech.

Under the agreement, Novartis will produce at least 24 million doses of the vaccine in 2022 in its facilities in Ljubljana, Slovenia.

This year, Novartis had an agreement for the fill and finish of more than 50 million doses.

For the agreement pertaining to 2022, Novartis intends to obtain bulk mRNA from BioNTech to fill into vials under sterile conditions. The company will return the vaccine doses to BioNTech for distribution.

In related news, Pfizer recently announced data from a Phase 3 study, which found that a booster dose of its vaccine was 95.6% effective against COVID-19 in a period when the Del…

Johnson & Johnson rises on Q3 earnings beat

Johnson & Johnson (NYSE:JNJ) shares ticked up today on third-quarter results that topped the consensus earnings forecast.

The New Brunswick, N.J.-based company posted profits of $3.7 billion, or $1.37 per share, on sales of $23.3 billion for the three months ended Sept. 30, 2021, for a 3.2% bottom-line gain on sales growth of 10.7%.

Adjusted to exclude one-time items, earnings per share were $2.60, 25¢ ahead of Wall Street, where analysts were looking for sales of $23.7 billion.

Get the full story at our sister site, MassDevice.

The European Union has become a leading COVID-19 vaccine exporter

The European Union is now one of the largest exporters of COVID-19 vaccines globally, having provided 150 nations with more than one billion vaccine doses.

The U.S. has exported fewer than 200 million vaccine doses to date but has pledged to donate more than one billion.

China has pledged to donate two billion doses by the end of the year. As of September 23, the Chinese foreign ministry stated that China had exported 1.2 billion doses to more than 100 countries.

The EU announced in September that it would provide an additional 200 million doses to low-income countries in Africa and elsewhere.

“We know that other countries also have to step up,” EU Commission President Ursala von der Leyen told the AP. “That’s the only way to beat the pandemic.”

To date, 47.6% of the world’s population has received at least one dose of vaccine, according to Our World in Data. But most of those doses have gone to middle- and high-income nations. Less than 3.…

What to consider before renewing your serialization contract

As we kickstart the last quarter of 2021, the federal deadline for full interoperability in pharmaceutical serialization, as dictated by the DSCSA (Drug Supply Chain Security Act), will soon reach its two-year countdown on November 27. Since November 2018, all manufacturers, including virtual manufacturers and brand owners, have been required to serialize products at the lowest salable unit. Products that do not contain a unique serial number on the packaging, along with other required information (GTIN, serial, lot and expiry date), are not authorized to be sold or purchased. As stated in the guidelines, “Failure to comply with DSCSA can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties.”

Technical challenges coupled with a global pandemic have hindered the roadmap towards serialization compliance. Pressured by the supply chain amidst the COVID-19 outbreak, the FDA announced an enforcement discretion on verifying s…

DuPont expands pharma bottle closure offerings

DuPont (NYSE:DD) has debuted a new line of Liveo-branded pharma bottle closures. The one-piece silicone stoppers and tubings are composed of biomedical-grade platinum-cured silicone elastomers. The pharma bottle closures are intended to seal threaded glass and plastic bottles and containers intended for critical fluid transfer, media and buffer pooling and storage, and sample collection in biopharmaceutical and biotechnology processes.

The Wilmington, Delaware–based company said that the Liveo product line is designed to reduce leak and contamination risk.

The company creates the one-piece silicone seal components based on end users’ specific needs. DuPoint manufactures the components in a clean manufacturing environment within an FDA-registered site in Michigan.

The bottle closures also support sterilization using autoclave and gamma irradiation.

The company offers the cured silicone seal parts that support GL45 and 38-430 neck bottles and contai…