Pharmaceutical Processing World Archives - Page 62 of 64

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…

Inovio to scale up production of smart delivery device for potential COVID-19 vaccine

Inovio Pharmaceuticals (NSDQ:INO) announced that it received $71 million from the U.S. Defense Dept. to support its Cellectra 3PSP smart device.

Funding from the DoD is set to support large-scale manufacturing for the Cellectra 3PSP and the procurement of Cellectra 2000 devices, which are used to deliver INO-4800 directly into the skin. It may also be used to deliver a potential COVID-19 vaccine.

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

HHS taps Pfizer to produce millions of COVID-19 vaccine doses

[Photo by Fusion Medical Animation on Unsplash]

Two U.S. government agencies today announced an agreement with Pfizer (NYSE:PFE) for production and delivery of 100 million doses of a COVID-19 vaccine.

The U.S. Dept. of Health and Human Services, along with the U.S. Defense Dept., agreed to the large-scale production and U.S. delivery deal once Pfizer’s vaccine is successfully manufactured and approved. In addition to the 100 million doses initially agreed upon. the U.S. government will be able to acquire an additional 500 million doses.

Get the full story at our sister site, Drug Discovery & Development.

How Seeq software can help predict chromatography column failure

It’s possible to use advanced analytics to predict biopharmaceutical failures, allowing corrective action to be taken before batches are lost or quality is degraded. A Seeq expert explains.

Joe Reckamp, Seeq

[Chromatography image courtesy of Seeq]

The biopharmaceutical industry uses chromatography processes extensively. Along with filtration, they are one of the most important separation and purification unit operations. These two processes affect quality and consistency significantly.

Chromatography is the principal purification unit operation in biologics synthesis, and it requires precise monitoring of column integrity and efficiency. Chromatography columns consist of packed resin or media used to separate solution components based on chemical or physical properties such as size, charge, hydrophobicity, or affinity. As the chromatography column is cycled, degradation of the resin ligand can …

Smiths Medical lands major vaccine-related contract

Smiths Medical announced today that it has landed a federal contract to produce more than 78 million syringe-and-needle units and $20 million in federal funding to expand its Keene, N.H. plant to produce them.

The Plymouth, Minn.-based company said it received an order for 78.6 million syringe-and-needle units and that BARDA and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense will foot $20 million of the Smiths’ $38 million capital expansion project in Keene. The partnership will increase needle production capacity by 125 million units per year, according to the company. The federal government will have priority access to this expanded capacity for vaccination efforts dedicated to COVID-19, flu vaccines and future pandemics.

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

Moderna, Catalent partner on COVID-19 vaccine candidate manufacturing

Moderna (NSDQ:MRNA) and Catalent (NYSE:CTLT) today announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Ind.

Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24×7 manufacturing operations at the site to support production of an initial 100 million doses intended to supply the U.S. market starting in the third quarter of 2020. The companies said they are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses. Somerset, N.J.-based Catalent will also provide clinical supply services from its facilities in Philadelphia, including packaging and labeling, as well as storage and distribution to support Moderna’s Phase 3 clinical study for this candidate.

The randomized, 1:1 placebo-controlled trial is expected to b…