Pharmaceutical Processing World Archives - Page 62 of 64

Unclear path for drug-pricing reform after Dem sweep

Photo by Anna Shvets from Pexels

With Democrats having gained control of the Senate and the presidency, some form of drug-pricing reform is likely. But with the raging COVID-19 pandemic and ongoing threats to the Affordable Care Act, Democrats are more likely to focus on those issues in the near term, according to Barrett Thornhill, a partner at the public affairs firm Forbes Tate in a call with UBS analysts.

The political dynamics of the House is one challenge. Even though Democrats have narrow control of the House, they also have an increasingly vocal progressive wing. For that reason, bipartisan healthcare policy from the Senate could “actually have some trouble when it goes to the House because it’s not left enough,” Thornhill said.

COVID-19 itself has stymied prior legislative attempts at drug-pricing reform, while President Trump’s executive orders face ongoing legal challenges.

Significa…

Catalent to acquire Acorda’s manufacturing and packaging operations

Catalent (NYSE:CTLT) has entered into a definitive agreement to purchase a dry-powder inhaler (DPI) capsule manufacturing and packaging facility from Acorda Therapeutics (NSDQ:ACOR).

The acquisition will enable Catalent to establish a center of excellence for spray-dried dispersion for DPI capsule manufacturing. The transaction will also expand Catalent’s existing U.S.-based commercial-scale capabilities in metered-dose inhalers and nasal inhalation technologies.

Under the terms of the deal, Catalent will acquire Acorda Therapeutics’ 90,000-ft2 CGMP facility in Chelsea, Mass., near Boston Logan International Airport. The site houses GEA NIRO PSD-1, PSD-4 and PSD-7 spray-drying units.

The transaction is subject to the customary closing conditions. The companies anticipate that the transaction will be finalized in the first quarter of the year. Once the deal is finalized, Acorda Therapeutics’ workforce at the facility will become Catalent employees.

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8 hurdles related to COVID-19 vaccine distribution

Pfizer-BioNTech vaccine image courtesy of Wikipedia

While vaccines remain the most powerful tool in achieving herd immunity for COVID-19, mass-vaccination has thus far proven more challenging than anticipated in many parts of the world. There are expected challenges, such as dealing with the subarctic storage requirements (–112º to –76º F) of the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). But the vaccine rollout is posing a series of challenges, many of which have been hard to anticipate.

1. Lack of standardization

One factor slowing COVID-19 vaccine distribution is confusion. “One of our biggest challenges right now is just lack of standardization across the U.S.,” said Marsha Flores Harris, product manager for FDB Prizm, a knowledge base platform from privately-held First Databank.

Not only is there variability in the storage requirements for the vaccines likely to be used in …

JanOne selects partner for bottling for PAD drug

JanOne recently announced that it has forged a partnership with a company to bottle and label its JAN101 drug.

JanOne said it is preparing its investigational new drug application for FDA submission as a potential treatment for vascular complications caused by COVID-19. The drug is already planned for use in Phase 2b trials as a treatment for peripheral artery disease that is expected to start in the first quarter of 2021.

JAN101 is a sodium nitrate-based compound that has been shown to improve blood flow, restore vascular function, mitigate inflammation and prevent potential tissue damage in major organs.

“Having world-class partners is essential to our success and we continue to build our extended team with some of the most innovative and reputable companies in the world,” CEO Tony Isaac said in a news release.

The company said it expects to submit the IND for the treatment of COVID-19 vascular complications in the next few weeks. It…

Report: Top FDA official vows to quit if vaccine approved prematurely

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.

“I could not stand by and see something that was unsafe or ineffective that was being put through,” Marks told Reuters. “You have to decide where your red line is, and that’s my red line. I would feel obligated (to resign) because in doing so, I would indicate to the American public that there’s something wrong.”

Public health officials have expressed concern that the administration might move too quickly on a COVID-19 vaccine a…

Kohlberg & Co. snaps up majority stake in PCI Pharma Services

Private equity outfit Kohlberg & Co. announced today that it has agreed to acquire a majority stake in pharma supply chain outsourcer PCI Pharma Services.

Abu Dhabi-based sovereign investor Mubadala Investment is also making a significant investment in Philadelphia-based PCI. Financial terms of the deal were not disclsoed.

Private markets investment manager Partners Group, previously PCI’s majority owner, will retain a meaningful minority stake.

PCI Pharma Services provides a broad range of integrated pharmaceutical supply chain solutions from the earliest stages of drug development through to commercial launch. It boasts global capabilities for drug development and manufacturing, clinical trials services and commercial packaging services — with 25 GMP facilities across six countries rougly 3,900 employees worldwide.

“Our teams at PCI have embarked on a purposeful journey over recent years to transform the company by executing a successf…

Why wet storage is key for biopharmaceutical single-use pH sensor performance

For biopharmaceutical single-use applications, pH sensors designed for wet storage deliver needed long shelf life and one-point calibration.

Brandon Haschke, Emerson

Biopharmaceutical SUT manufacturing methods, which include disposable bioreactor bags, create challenges for performing analytical measurements such as pH. [Image courtesy of Emerson]

Biopharmaceutical processing applications, and especially single-use technology (SUT) manufacturing methods, present unique challenges for performing pH measurements. Quite often these processes are automated, and certainly they all must be monitored, so there is always a need to sense the process media pH.

SUT methods provide scalability and savings for manufacturers, in large part due to the use of durable and sterile disposable bioreactor bags. Instrumentation associated with SUT production must likewise be disposable, unless traditional sensors can…

Fujifilm Diosynth lands $265m to produce COVID-19 vaccine

Fujifilm Diosynth Biotechnologies announced that its College Station, Texas, site will manufacture a COVID-19 vaccine candidate under a $265 million federal contract.

The contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies said it received the federal task order through the Texas A&M System Center for Innovation in Advanced Development & Manufacturing (CIADM), a public-private partnership between the government’s Biomedical Advanced Research and Development Authority (BARDA) and the university. CIADM subcontracts manufacturing to the Fujifilm Diosynth Biotechnologies’ owned-and-operated flexible biomanufacturing facility in College Station. The task order reserves manufacturing at the plant capacity in through the end of 2021.

The money will help accelerate Fujifilm Diosynth’s planned facility expansion by several months, now with an anticipated completion by fall 2020. The Texas…

SP Industries announces partnership with Ecodyst

Fill-finish drug manufacturing solutions developer SP Industries announced that it entered into a partnership agreement with evaporator developer Ecodyst.

Apex, N.C.-based Ecodyst offers a full range of single-sample evaporators with self-cooling condenser technology. The distribution partnership aims to utilize the Ecodyst products to complement Warminster, Pa.-based SP Industries’ SP Genevac with parallel centrifugal evaporators to eliminate the solvent-drying bottleneck in drug discovery and synthetic organic chemistry.

“This new partnership enables our SP Genevac brand to be the comprehensive, one-stop-shop for all evaporation solutions,” SP Industries CEO Brian Larkin said in a news release. “Ecodyst’s revolutionary single sample evaporator line complements our SP Genevac world-renowned centrifugal evaporators for parallel sample evaporation and together lets us work with customers more effectively to help streamline and accelerate the dr…

Teknova announces new CEO

Cell culture media, protein purification and molecular biology reagent manufacturer Teknova announced that it appointed Stephen Gunstream as its new CEO.

Gunstream has nearly 20 years of experience in life sciences, having previously served as VP and GM for the research and clinical business at BD Biosciences, as well as the CCO at Integrated DNA Technologies. He will take over for founder and retiring CEO Ted Davis, who said in a news release that the Gunstream “understands our culture and vision extremely well.”

“Teknova is a special company,” Gunstream said. “First and foremost, it is due to the people in the organization, and I feel very privileged to lead them as CEO. Ted has built a wonderful business that is always asking what we can do to advance scientific breakthroughs and then delivering. It is a great fit as my fundamental belief is that a business will be successful, no matter what, if you focus on the customer.”

Holl…

WMFTG announces the launch of its new Certa Plus pump series

Watson-Marlow Fluid Technology Group (WMFTG) announced that it launched its Certa Plus pump series for versatile fluid management in pharmaceuticals.

Certa Plus uses the company’s MasoSine sinusoidal pumping technology to function across a range of applications with lower shear, lower power consumption, full traceability and cleanability when transferring syrups, oils, creams and gels, according to a news release.

Wilmington, Mass.-based WMFTG says its product offers pulsation-free flow with no need for ancillary dampeners to improve flow meter accuracy and heat exchanger efficiency.

Additionally, Certa Plus can transfer and handle a wide range of challenging products with its continuous flow and high suction, supporting the efficient manufacturing of pastille products. It has also been rigorously tested to comply with up-to-date cleanliness regulations in the pharmaceutical industry and can be wet cleaned without dismantling and is steam steriliza…

Tekni-Plex introduces new Pentafill L + Fill bench-top vial filling/sealing machine

Tekni-Plex announced that it is debuting a new bench-top vial filling and sealing machine designed for lab research and small quantity start-up production.

The Pentafill L + Fill machine is an upgrade to Tekni-Plex’s previous Pentafill L unit, which only seals vials. The latest tech accommodates five-unit strips of 0.33-, 0.6-, 1-, 3-, 5- and 10-ml plastic (PE, LDPE, LLDPE, HDPE, PP and EVOH barrier) vials, according to a news release.

Wayne, Pa.-based Tekni-Plex’s Pentafill L + Fill allows for mimicking the results of a full-scale production machine via a compact, bench-top unit with a heating head, cold-molding pliers and a sealer. The machine is available in the U.S. and in Europe.

“Up until now, pharmaceutical companies and labs had to manually fill small-scale production vials before inserting them into the machine for sealing,” Tekni-Plex healthcare packaging global senior director of marketing and strategy Melissa Green said in t…