Contract Manufacturing, Sterile, Aseptic Processing

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Understanding both the challenges and solutions of aseptic manufacturing.

ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms.

Curia and the US government have entered into a cooperative agreement to expand fill/finish capability for injectable medicines.

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.

Global CDMO, ten23 health, has acquired filling technology and drug product manufacturing expert, swissfillon, enhancing its integrated offering.

Febles will oversee day-to-day aseptic manufacturing at Pharmaceutics International, Inc.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

Scenario modeling informs planning for current and future manufacturing needs.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

A holistic approach to validation and quality assurance is essential.

Apiject was approved for a $590-million loan from the US to build in-country capacity for COVID-19 vaccines and therapeutics.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.

Catalent Biologics increased capacity at its Bloomington, IN Facility.

Catalent completes purchase of biologics fill-finish and oral solid dose facility in Anagni, Italy

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.