Mfg News: FDA, GSK, Siga, & More
A roundup of manufacturing news from the US Food and Drug Administration, Siga Technologies, Grunenthal and GSK. Highlights below.
* FDA’s CBER Launches Interactive Site Tours for Gene & Cell Therapy Mfg Facilities
* US Gov’t, Siga in $113-M Supply Pact for Smallpox, Mpox Antiviral Drug
* Grunenthal Investing $87 M To Expand Solid Dosage Mfg Capacity in Latin America
* GSK Begins Shipment of Flu Vaccine
FDA’s CBER Launches Interactive Site Tours for Gene & Cell Therapy Mfg Facilities
The Office of Therapeutic Products (OTP) of the Center for Biologics Evaluation and Research (CBER) of the US Food and Drug Administration has launched the Cellular and Gene Therapies Interactive Site Tours Program, a new program to give CBER regulatory project managers and/or reviewers an opportunity to tour manufacturing facilities developing cellular and gene-therapy products and to exchange regulatory experiences with their industry counterparts. With this program, CBER intends to enhance review efficiency and quality by providing CBER staff with a better understanding of the biotechnology manufacturing industry and its operations.
The FDA is inviting companies developing cellular and gene therapy products interested in participating in this program to contact OTP for more information. Companies may send proposed agendas to the agency by August 14, 2024.
The proposed site tours, which may last a few days, will include a small group from CBER’s OTP consisting of regulatory project managers and/or reviewers and potentially senior staff to observe operations of biologics manufacturing and/or packaging facilities, pathology/toxicology laboratories, and regulatory affairs operations. The tour is not intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant to provide an avenue for open dialogue between CBER/OTP staff and industry representatives.
During the Interactive Site Tours Program, regulatory project managers and reviewers may also participate in daily workshops with their industry counterparts, focusing on selective regulatory issues important to both OTP staff and industry. The primary objective of the daily workshops is to understand the team approach to biological product development, including discovery, nonclinical and clinical evaluation, post marketing activities, and regulatory submission operations. The overall benefit to regulatory project managers and reviewers will be exposure to project management, team techniques, and processes employed by industry to gain a better understanding of industry processes and procedures.
Source: FDA
US Gov’t, Siga in $113-M Supply Pact for Smallpox, Mpox Antiviral
Siga Technologies, a New York-based bio/pharmaceutical company, reports the US Department of Health and Human Services has exercised a procurement option for the delivery of approximately $113 million in treatment courses of the oral version of Siga’s TPOXX (tecovirimat), an antiviral medicine approved in the US and Canada for the treatment of smallpox and elsewhere for other orthopoxviruses.
TPOXX is approved by the US Food and Drug Administration for treating smallpox disease in adults and pediatric patients weighing at least 13 kg. Following US approval, Health Canada also authorized the use of oral TPOXX to treat smallpox disease in adults and pediatric patients weighing at least 13 kg. Oral TPOXX, under the brand name Tecovirimat-SIGA, was later approved by the European Medicines Agency, the Norwegian Medicines Agency, and the UK’s Medicines and Healthcare products Regulatory Agency for treating smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox in adults and children weighing at least 13 kg.
Source: Siga Technologies
Grunenthal Investing $87 M To Expand Solid Dosage Mfg Capacity in Latin America
Grünenthal, an Aachen, Germany-based bio/pharmaceutical company, has announced investments of EUR 80 million ($87 million) to expand solid dosage manufacturing capacity at its Latin American production sites.
In Santiago de Chile, a 3,500-square-meter solid-dosage manufacturing plant has been completely refurbished to create a facility with production capacity of 1.8 billion tablets annually. Grünenthal aims to complete the certification process for the facility with the European Medicines Agency (EMA) by November 2025 to enable the supply of medicines from Chile to Europe.
In Quito, Ecuador, the company is adding a new 1,800-square-meter plant for tablets. The facility will be part of the company’s 50,000-square-meter campus in Ecuador, which has manufacturing capabilities for solid, semi-solid, and liquid pharmaceuticals. Starting in 2025, the new facility will produce up to 300 million tablets for pain-management products for European markets.
Grünenthal operates a production network with five manufacturing sites in Germany, Switzerland, Italy, Chile, and Ecuador.
Source: Grünenthal
GSK Begins Shipment of Flu Vaccine
GSK has started shipping doses of its trivalent influenza vaccines (Flulaval and Fluarix) to US healthcare providers and pharmacies in preparation for the 2024-25 flu season. This follows a licensing and lot-release approval from the US Food and Drug Administration.
In February 2024, the World Health Organization (WHO) recommended the removal of B/Yamagata strains from seasonal influenza vaccines and that egg-based trivalent vaccines for the 2024-2025 Northern Hemisphere influenza season contain the following: A/Victoria/4897/2022 (H1N1)pdm09-like virus; A/Thailand/8/2022 (H3N2)-like virus; and B/Austria/1359417/2021 (B/Victoria lineage)-like virus. In partnership with regulatory bodies, GSK worked to ensure production, approval and availability of trivalent influenza vaccines with the recommended composition for the 2024-25 flu season.
GSK expects to distribute over 36 million doses of its trivalent influenza vaccines in the US this season. Both Flulaval and Fluarix will be available in a 0.5-mL, single-dose, pre-filled syringe and are indicated for people six months of age and older.
Source: GSK
