Pharmaceutical Processing World Archives - Page 47 of 64

Biovac to make and distribute Pfizer-BioNTech COVID-19 vaccine in Africa

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) today announced an agreement with Biovac to manufacture the companies’ COVID-19 vaccine for distribution in Africa.

Cape Town, South Africa-based Biovac will perform manufacturing and distribution activities within Pfizer and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network to aid in distribution within the African Union, according to a news release. The technical transfer, on-site development and equipment installation activities for Biovac will begin immediately.

Pfizer and BioNTech’s global vaccine supply chain and manufacturing network now spans three continents, the companies said, with more than 20 million manufacturing facilities.

They expect Biovac’s Cape Town facility to be incorporated into the COVID-19 vaccine supply chain by the end of 2021, with Biovac slated to obtain drug substance from European facilities. The manufacturing of finished doses will c…

HCW Biologics announces IPO with $56 million valuation

HCW Biologics Inc. (NASDAQ:HCWB) has announced that it is launching an underwritten initial public offering of 7,000,000 shares of common stock. Initially valued at $8.00 per share, the IPO would generate approximately $56.0 million. That sum does not include underwriting discounts, commissions and other offering expenses.

The Miramar, Fla.–based preclinical-stage company specializes in immunotherapies that address chronic, low-grade inflammation and age-related diseases. It also has several experimental treatments for several cancers.

The company expects the stock to begin trading on July 20 and the offering to close on approximately July 22, 2021.

The company has developed a proprietary immunotherapeutic platform known as Tissue factOr-Based fusIon (TOBI) based on the tissue factor scaffold.

The company’s lead product candidate is HCW9218, a potential treatment that could minimize adverse events from chemotherapy.

Stäubli Robotics appoints new pharma and medical device head

The Pfäffikon, Switzerland–based mechatronics and robotics company has named Olivier Cremoux to be the deputy head of pharma and medical device for Stäubli Robotics North America. Cremoux has worked in various Stäubli divisions since 2015 and has served as an international business development manager. In 2018, he began a stint as a North American business development manager for robotics.

Oliver Cremoux

In a statement, Cremoux stated that Stäubli Robotics’ pharma and medical device segments are “strategic and growing markets” for the company and have been for more than 20 years. “High throughput screening, aseptic fill/finish, orthopedic surgery, bio-printing and cell culturing are examples of processes where Stäubli Robotics started as a pioneer and became a reference,” Cremoux said. “With COVID-19 pandemic, robotics became even more essential to our customers, from drug production to COVID test manufactur…

Using RVI to prevent contamination and maintain purity of pharmaceuticals

Image courtesy of Olympus.

Strict purity and contamination control of pharmaceutical manufacturing facilities is required under various international standards, such as ASME (American Society of Mechanical Engineers), AWS (American Welding Society) and local regulatory authorities such as the U.S. Food and Drug Administration.

Bacterial or foreign-particle contamination in production-line equipment can cause serious health issues for consumers and shake public confidence in the industry.

Preventing contamination in medication production lines is one of the main goals of good manufacturing practices (GMP). Following GMP is a prerequisite for the pharmaceutical industry to prevent poor quality or incorrect mixtures of elements from reaching the consumer. GMP requirements include implementing strict equipment maintenance and cleaning protocols supported by QC and QA inspections and audits, all backed by …

BioNTech to buy Kite’s neoantigen TCR cell therapy R&D platform and Maryland plant

BioNTech (NSDQ:BNTX) announced today that it acquired Kite’s solid tumor neoantigen T cell receptor (TCR) platform and its facility in Maryland.

Mainz, Germany-based BioNTech said in a news release that the acquired clinical manufacturing facility in Gaithersburg, Md., will provide production capacity in support of U.S. clinical trials while complementing the company’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany.

Kite’s Maryland facility will also support the development of BioNTech’s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T cell amplifying mRNA vaccine (CARVac) and Neostim platforms, as well as the newly acquired, individualized neoantigen TCR program.

The company said that all Kite employees at the Gaithersburg plant will be offered employment with BioNTech prior to the closing of the acquisition, while it also plans on further …

Pfizer, subsidiaries agree to pay $345M in EpiPen pricing lawsuit

Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices.

Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by Pfizer and its Mylan subsidiary, which markets the EpiPen.

Get the full story at our sister site, Drug Delivery Business News.

Ensuring accuracy and compliance during repackaging

Photo by cottonbro from Pexels

The accuracy of serialization data and compliance by trading partners provides the foundation for compliance with the Drug Supply Chain Security Act (DSCSA). During the pharmaceutical packaging process, however, there may be unplanned events that jeopardize the integrity of the data, reduce productivity and increase operational costs.

Equipment jams, power failures, product damage during handling and operator errors will happen. Additionally, a product that is processed without incident may need to be removed from a pallet for periodic QA sampling. All of these events impact the many serialization-related requirements with which pharmaceutical manufacturers, repackagers and Contract Manufacturing Organizations (CMOs) must now adhere.

Factors that necessitate that packaging be reworked, and like many choices in life, you can either do it the hard (costly) way or the easy …

Israel recommends third COVID-19 vaccine dose for the immunocompromised

Photo by cottonbro from Pexels

Israel is following a similar path to the U.K. in its plans to administer a third dose of COVID-19 vaccine to a subset of patients.

U.K. officials recently announced their initiative to provide a booster to high-risk patients, but those plans are preliminary.

Both Israel and U.K. have concluded that fully vaccinated individuals are unlikely to require a booster dose later this year.

The Israeli government, however, is taking more definitive steps in issuing guidance for people who are immunocompromised to receive a third dose of the vaccine from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX). Some medical centers have already begun administering boosters to those who are severely immunocompromised including cancer patients and recipients of organ transplants. While the country is considering providing a third dose for those 60 and older, it hasn’t yet reached a d…

Biotech Agenus acquires 120 acres in biomanufacturing center in California

Agenus (Lexington, Mass.) has purchased 120 acres in the California Biomanufacturing Center located in Vacaville near Sacramento.

Agenus specializes in immuno-oncology products, which span checkpoint antibodies, cell therapies, vaccines and adjuvants.

Agenus purchased the parcels from A.G. Spanos, a housing developer.

Vacaville is aiming to spur the growth of its biotech industry. Currently, the largest biotech hubs in the state are in the San Francisco Bay Area and Southern California.

“We are excited to expand our manufacturing and process research capabilities in Vacaville as we contemplate the commercialization of our exciting pipeline of high-tech cancer treatments,” said Garo Armen, CEO of Agenus, in a statement. “The city of Vacaville is a true partner with their commitment; Vacaville’s close proximity to talent and its high quality of life offerings were amongst the key considerations in our decision.”

Vacaville, a city of approxima…

Meta-analysis finds some ivermectin benefits in COVID-19 patient

Ivermectin image from Wikipedia

An analysis published in Open Forum Infectious Diseases found a 56% reduced risk of mortality for COVID-19 patients taking the anti-parasitic drug ivermectin compared to standard of care or another therapy. The study pulled data from 24 randomized trials involving 3,328 patients with moderate to severe COVID-19.

The study also found that ivermectin was “associated with reduced inflammatory markers” and quicker viral clearance.

Ivermectin, a widely available inexpensive drug used to treat worm and scabies infections in humans and animals, has emerged as a COVID-19 treatment in several parts of the world. Its use, however, has been controversial. WHO has counseled against its use as a COVID-19 treatment outside of clinical trials. And Merck, an ivermectin manufacturer, released a statement in February saying there was no scientific evidence to support the use of ivermecti…

IMF approves $650B to help countries pay for COVID-19 vaccines

The executive board of the International Monetary Fund (IMF) today approved a $650 billion allocation for COVID-19 vaccines.

IMF managing director Kristalina Georgieva issued a statement today confirming that the executive board concurred in her proposal for a new general Special Drawing Rights (SDR) allocation of $650 billion — the largest allocation in the IMF’s history — to address long-term needs for what she called “the worst crisis since the Great Depression.”

According to the statement, Georgieva will present the SDR allocation proposal to the IMF’s board of governors for their consideration and approval, which, if obtained, would lead to the expectation that the allocation is completed by the end of August.

“This is a shot in the arm for the world,” Georgieva said. “The SDR allocation will boost the liquidity and reserves of all our member countries, build confidence, and foster the resilience and stabili…

Biden and Pelosi pursuing plans to cap drug prices

Joe Biden and Nancy Pelosi images from Wikipedia

President Biden has instructed FDA to develop a plan to import prescription drugs from Canada while asking federal officials to create a “comprehensive plan” to cut drug prices within 45 days.

Biden has also recommended that FTC block “pay for delay” agreements from pharma companies paying generic drug makers to hold off on introducing competitive products.

The proposals are included in a far-reaching executive order with several healthcare provisions. The main thrust of the order, however, is stimulating competition in the economy.

Earlier this year, Biden asked Congress to allow Medicare to negotiate drug prices, which was also a goal spelled out in the 2019 House Bill H.R. 3 that Democrats reintroduced in April.

Biden included the recent effort to give Medicare drug negotiation powers in an executive order intended to spur economic comp…