Contract Manufacturing, Sterile, Aseptic Processing

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

Aseptic techniques must be practiced throughout all stages of biologics production.

Vetter is further expanding its production capacity and services at its Rankweil, Austria site.

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.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

Industry experts discuss the need for stricter environmental controls, whether to incorporate single-use technologies, and areas for improved automation.

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.

The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

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.

Automation offers benefits for sterile manufacturing in 503B outsourcing facilities.

Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value.

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.

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.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

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

Catalent Biologics increased capacity at its Bloomington, IN Facility.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.

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

Lubrizol Life Science Health adopts new name and opens commercial manufacturing facility.

The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.

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