Pharmaceutical Technology Editors

PCI Pharma Services announced an expansion of capabilities and capacities to its manufacturing facility in Bedford on May 10, 2022. The company is investing $100 million into the facility’s aseptic liquid fill-finish and sterile lyophilization technology.

According to a company press release, the planned expansion consists of a 50,000 ft.² facility that will contain an aseptic fill-finish line with a fully isolated containment system. It will also have twin lyophilizers with auto-loading and unloading systems that can complete 400 vials per minute on a sterile fill-finish line.

“We are excited to introduce clients to our newest facility, which is part of our broader strategy to provide integrated end-to-end drug development, manufacturing, and packaging capabilities,” said Salim Haffar, CEO, PCI Pharma Services. “Our investment in these facilities will ensure that PCI continues to leverage new capabilities in complex formulations, aseptic fill-finish, and lyophilization to meet the needs of our global clients, particularly as biologics continue their strong growth trajectory.”

The Bedford facility, which was obtained in the acquisition of Lyophilization Services of New England in Dec. 2021, is dedicated to high-volume lyophilization, liquid filling, and multi-product handling from one format to another. This announcement follows the company’s construction of the New England Clinical Center of Excellence in Bridgewater, Mass., as well as expansions to their sites in Berlin, San Diego, Rockford, Ill., and Melbourne, Australia.

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PCI Pharma Services is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.

PCI Pharma Services Invests $100 Million in Bedford, NH Manufacturing Facility 

Natoli announced the date and location for its latest training workshop on May 9, 2022. The “Tablet Press & Tooling: Applied Learning Experience” session will be from June 14-16 at the company's global headquarters in St. Charles, Mo.

Natoli invites supervisors, quality assurance and quality control personnel, and maintenance technicians at any stage to attend the session. The course, which is offered several times each year, will cover:

Assembly and disassembly of all main components of a rotary tablet press

Relationships among maintenance, inspections, operations, and troubleshooting

“Operators’ jobs are hands-on, so their training should be, too,” said Dale Natoli, president and CEO, Natoli Engineering. "The heavy focus on hands-on experience and classroom instruction provides the perfect balance to show attendees how tablet presses and tooling work in theory and in practice."

The “Tablet Press & Tooling: Applied Learning Experience” session will be held from June 14-16 at Natoli’s global headquarters in St. Charles, Mo.

Natoli Announces Tablet Press & Tooling Training Schedule at Company Headquarters

FDA announced on May 10, 2022 that its Center for Drug Evaluation and Research (CDER) has launched a new program to increase and speed up the development of treatments for unmet needs of patients with rare diseases. The program, which will be managed by CDER’s Rare Diseases Team, will use CDER’s expertise to coordinate activities involved in the treatment of rare diseases.

According to FDA, development of treatments for rare diseases is complex, and using well-established trial designs and endpoint selection can be challenging because of the limited understanding of these conditions. The Accelerating Rare disease Cures (ARC) program will support the development and approval of these treatment options through scientific and regulatory engagement.

“CDER is optimistic about the future of rare disease drug development and is looking forward to continuing this important work under the new CDER ARC Program—together with patients, advocacy groups, academics, industry, and other partners—to address the significant unmet needs of patients and families living with rare diseases,” the agency stated in a press release.

The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.

FDA Launches Accelerated Rare Disease Cures Program

FDA published draft guidance on May 9, 2022 that describes the benefit-risk principles the agency applies when conducting product quality-related assessments of chemistry, manufacturing, and controls information it receives as part of new drug applications (NDAs), biologics license applications (BLAs), and supplements to drug approval applications. Data and supporting information are submitted to the agency by sponsors to demonstrate a drug product’s identity, strength, quality, and purity. FDA assesses this information to determine if an “applicant’s product development studies, manufacturing process, and control strategy will consistently result in a finished product of acceptable quality when manufactured at the facilities named in the application.”

FDA considers the overall benefits and risks of the product when deciding to approve a product application. 

Benefit-Risk Considerations for Product Quality Assessments

details how the agency assesses these risks, the sources of uncertainty, and mitigation strategies. Unresolved product quality issues, and how they may be addressed, are also discussed in the document.

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

FDA Publishes Draft Guidance on Quality Assessments

FDA announced on May 10, 2022 that it has approved a new indication for Olumiant (baricitinib) for treating adults hospitalized with COVID-19 who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Emergency Use Authorization (EUA) was first issued in November 2020 for Olumiant (baricitinib) in combination with remdesivir. The EUA was revised by FDA in July 2021 to authorize Olumiant as a standalone treatment. The drug still has EUA status for hospitalized pediatric patients 2–18 years of age that require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. The Letter of Authorization and associated fact sheets have been revised to remove the population covered under the approved indication.

“The FDA continues to work with developers, researchers, manufacturers, and partners to help expedite the development and availability of therapeutic drugs and biological products to prevent or treat COVID-19 through its 

Coronavirus Treatment Acceleration Program

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

FDA Approves Olumiant (baricitinib) to Treat COVID-19 in Hospitalized Adults

908 Devices, a US-based company specializing in chemical and biomolecular analytical devices, has formed a collaboration with CPI to optimize mammalian cell-culture media and feeding strategies. The aim of the project is to improve growth, protein titer, and protein quality attributes.

Under the agreement, CPI researchers will employ 908 Devices’ REBEL desktop analytical device for at-line cell-culture media analysis, which will help to identify and subsequently control key process parameters in bioprocessing workflows, the companies stated in an April 21, 2022 press release. Currently, 908 Devices and CPI scientists are implementing at-line media analysis for a Chinese hamster ovary cell line expressing a monoclonal antibody in small-volume cell culture bioreactor systems through to process scale-up. The scientists are monitoring nutrient levels critical to process stability and product quality and are ultimately controlling outcomes through the design of media formulations and the implementation of optimized feeding strategies, according to the release.

Time course data from the REBEL device provides information and insights into the cell metabolism, in addition to typical cell-culture parameters, such as cell count, viability, and basic metabolite data. These data sets are being mined with the goal of understanding specific amino acid depletion. Amino acid depletion could correlate with low titer and growth as well as potential protein quality attributes.

“The measurements from the REBEL device have enabled us to gain an improved understanding of the cell culture environment within a bioreactor,” said Bethany Kerr, team leader, Upstream Development at CPI, in the press release. “It has also enabled us to assess the impact of additional control over key process parameters. Data generated from the REBEL can be used to develop predictive models for feed control.”

Editors Note: A previous version of this story errenously stated that the companies partnered to develop cell culture media. This has been updated to clarify that the companies are partnering to optimize cell culture media.

908 Devices and CPI have formed a collaboration to optimize cell culture media to allow for improved process control.