Pharmaceutical Processing World Archives - Page 37 of 64

Tablet counter includes option for high-capacity hopper

Image courtesy of Deitz

The packaging machinery firm Deitz (Wall, New Jersey) has introduced the Pharmafill TC4 tabletop pill counter with an optional high-capacity hopper.

The optional high-capacity stainless-steel hopper can handle 63% more pills than Deitz’s standard hopper. The high-capacity hopper can accommodate 1.6 f3 of tablets, capsules, caplets, lozenges, soft gels or other solid oral-dose products.

Its large size can extend counting and filling operations while minimizing the need for refilling.

Operators can quickly remove the hopper for cleaning and changeovers.

The Pharmafill TC4 machine automatically feeds tablets from the hopper onto a rotating glass disc. Once the pills are on the disc, the machine orients them for a counting sensor and then discharges a defined amount into a bottle.

The Pharmafill TC4 system can process up to 2,000 tablets per minute.

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UK puts vaccine manufacturing goes up for auction

Image courtesy of VMIC

The U.K. government has put a manufacturing plant up for sale that was instrumental in the country’s plan to battle future pandemics.

According to The Financial Times, the plant, dubbed the Vaccine Manufacturing Innovation Centre (VMIC), had received at least £215 million of public funding since it was launched in 2018.

A handful of companies have placed bids for the 74,000 m2 plant, located in Harwell, approximately 15 miles from Oxford.

The U.K. had planned on using the facility to make vaccines for epidemics, but the COVID-19 pandemic has elevated the role of private industry in vaccine manufacturing.

The country had scheduled to complete work on the Vaccine Manufacturing Innovation Centre in 2023 but moved that date to spring 2022 in an earlier phase of the pandemic.

Created as a nonprofit organization, the Vaccine Manufacturing Innovation Centre (VMIC) …

Pfizer bolsters COVID-19 antiviral manufacturing capacity

Although Pfizer (NYSE:PFE) has yet to receive emergency use authorization for its Paxlovid COVID-19 therapy, it plans to manufacture 80 million courses of the drug by the end of 2022. Pfizer had initially planned on making 50 million courses of Paxlovid (PF-07321332/ritonavir) in the same time frame.

An interim analysis of the Phase 2/3 EPIC-HR study found the drug to be 89% effective at reducing hospitalization or death. Pfizer announced the launch of a Phase 1 study of PF-07321332 in March.

Pfizer has inked a $5.29 billion Paxlovid deal with the U.S. government.

One course of oral Paxlovid therapy would consist of two daily 150-mg doses for five days.

Meanwhile, molnupiravir, the antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has lost some of its luster. New data suggests the drug led to an absolute risk reduction against hospitalization or death of 3% compared to placebo. Furthermore, the drug led to a relative risk reduction of…

J&J joins Moderna and Pfizer in researching Omicron variant

Johnson & Johnson (NYSE:JNJ) has announced that it is collaborating with academic institutions internationally to gauge the effectiveness of its COVID-19 vaccine against Omicron and other SARS-CoV-2 variants.

In particular, J&J said it is conducting research on blood serum from clinical trial volunteers who have received single or multiple doses of its COVID-19 vaccine.

The company also vowed to design and develop an Omicron-specific variant vaccine if necessary.

“We remain confident in the robust humoral and cell-mediated immune responses elicited by the Johnson & Johnson COVID-19 vaccine demonstrated by the durability and breadth of protection against variants to date in clinical studies,” said Dr. Mathai Mammen, global head, Janssen Research & Development, in a press release. “Building on our long-term collaboration with scientists on the ground in South Africa and the ongoing real-world effectiveness studies being conducted with the J…

Optimizing control of pump-related biopharma production processes

Integrated pump controllers aid with operation of quaternary diaphragm pumps

Diaphragm pump technology. Image courtesy of Quattroflow.

While large-scale manufacturing of biopharmaceutical drugs is often fully automated, process development and small-scale manufacturing often still require manual interaction and control steps. This demands continuous monitoring by operators and sometimes results in a lack of consistency in the process. Achieving a higher level of accuracy and consistency is more achievable if the operation’s liquid-processing system possesses automated capabilities that can identify and tune into the proper manufacturing parameters.

A new technology – the integrated pump controller – can optimize pump performance in biotech-manufacturing activities by giving the operator the ability to automatically control such parameters as flow and pressure. This control will make it easier to run s…

OSHA suspends enforcement of COVID-19 vaccine mandate

Image courtesy of Pixabay.

The Biden administration will not proceed with enforcing its vaccine mandate for businesses with at least 100 employees given a recent decision by the U.S. Court of Appeals for the Fifth Circuit.

The administration had planned on putting the Occupational Safety and Health Administration (OSHA) in charge of administering the COVID-19 vaccine mandate. While a statement on the OSHA website proclaims that it “remains confident in its authority to protect workers in emergencies,” the agency agreed it would suspend enforcement of the emergency temporary standard (ETS) that would have required many U.S. employees to be fully vaccinated or face regular testing. However, OSHA could change course in the event of a further court order.

The U.S. Court of Appeals for the Sixth Circuit will hear the challenge to the OSHA-specific vaccine mandate.

For the time being, however, OSHA h…

4 things to keep in mind when selecting beta bags

Image courtesy of Central Research Laboratories

Life science products like pharmaceuticals, biologics and biosimilars that feature active pharmaceutical ingredients (APIs) require the safe, efficient, contamination-free, i.e., “aseptic,” handling of raw materials and finished products. Maintaining a sterile production process demands that all components used in a cleanroom or isolator be kept contaminant-free. Beta bags play a critical role in this process, but before selecting a beta bag brand or model, the aseptic-process operator should consider four things:

1. What is the main purpose of beta bags?

Alpha ports (sealed openings) used in cleanrooms and isolators give operators access to various components during an aseptic-production process, allowing the operator to retrieve items ranging from vial stoppers to syringe plungers, hand wipes to cable ties, and simple pen and paper. Contamination-free access …

Federal appeals court concludes Biden’s vaccine mandate poses ‘serious constitutional concerns’

Image courtesy of Unsplash

The U.S. Court of Appeals for the Fifth Circuit issued an opinion on November 12 concluding that the Biden administration’s vaccine mandate was ‘fatally flawed.’

A three-judge panel on the Fifth Circuit Court of Appeals has blocked the Occupational Safety and Health Administration’s (OSHA’s) plan to institute a vaccine mandate for employers with at least 100 workers. While the court has not ruled on the constitutionality of the mandate, it noted that the mandate poses “serious constitutional concerns.”

The Biden administration had planned on OSHA’s authority to enact an emergency temporary standard (ETS) in its vaccine mandate.

The Fifth Circuit opinion observed that OSHA has rarely enacted ETSs and that only one of those standards had survived legal challenges in the past fifty years.

The court criticized the mandate as being “overinclusive” in the sense it d…

Pneumatic conveyor can load reactors automatically

Image courtesy of Gericke

Process equipment specialist Gericke (Somerset, New Jersey) has introduced the DenseFlow PHF dense phase pneumatic conveying system, which can automatically transfer hazardous or non-regulated powders and other bulk materials from bags and sacks into reactors.

The company says the system can protect workers from exposure to toxic and hazardous materials and hazardous vapors while protecting product purity.

The system supports the automated feeding of multiple materials from up to 500 meters away from the reactor via an online portal.

The DenseFlow PHF is suitable for chemicals, pharmaceuticals and other reactants.

Because it transfers materials gently, the system safeguards the particle size and shape while reducing the risk of electrostatic charge.

California and Colorado to allow COVID-19 boosters for all adults

Flag images courtesy of Wikipedia.

COVID-19 vaccine booster eligibility has gradually expanded, but a significant portion of adults don’t meet the current criteria set forth by FDA and CDC.

California and Colorado have decided to sidestep the federal government by making all fully vaccinated adults in those states eligible for a booster.

California will require that six months have elapsed in order for recipients of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines to receive a third dose. Similarly, recipients of the J&J vaccine must wait at least two months before receiving the second dose of that vaccine. Both requirements mirror federal recommendations except for the provision that all fully vaccinated adults are eligible.

Now facing a significant wave of COVID-19 infections, Colorado is also making boosters available for all fully vaccinated adults.

In an…

Johnson & Johnson to spin off consumer segment

Recently, General Electric (NYSE:GE) and Toshiba (TYO:6502) announced their plans to slim down by spinning out core businesses. Now, Johnson & Johnson (NYSE:JNJ) is following a similar approach by making its consumer health business a standalone company.

J&J will retain its pharmaceutical and medical device segments.

Johnson & Johnson said in an announcement that it made the decision to boost operational performance and strategic flexibility.

The company’s consumer segment has been in the spotlight recently, given a rash of talcum powder lawsuits alleging the company’s talcum powder products contained asbestos.

J&J recently spun off a separate company known as LTL, and then transferred the talcum-powder lawsuits into LTL.

The latest consumer health company will be publicly traded.

Baxter bolsters fill-finish capabilities with $100M investment in Germany

Baxter International (NYSE:BAX) plans to invest roughly $100 million to expand a sterile fill-finish manufacturing plant in Halle/Westfalen, Germany.

BioPharma Solutions (BPS), a subsidiary of Deerfield, Illinois–based Baxter, will manage the new facility.

BPS supports pharmaceutical companies through a range of offerings, including scientific support, sterile contract manufacturing and parenteral delivery systems.

Baxter anticipates that the construction of a new manufacturing building will begin in 2022, and the plant will be operational in 2024.

The new facility will include equipment for lyophilization (free drying), which can improve the stability and shelf life of drugs, vaccines and other products.

The facility will also have an aseptic syringe filling line to produce pre-filled syringes to meet the growing demand for that product.

The BPS site in Halle/Westfalen has been operational for more than 60 years.

Baxter has m…