Facilities & Capacity Archives - Page 32 of 73 - BioProcess InternationalBioProcess International

Politics and COVID driving manufacturing back to the US, says Avid

“Southern California is not a bad place to be right now,” says CDMO Avid Bioservices as it discusses how politics and COVID-19 have made localized manufacturing more appealing. Contract development and manufacturing organization (CDMO) Avid Bioservices’s Myford and Franklin facilities are in California. Meanwhile, a third plant is in the works at the Myford site. But speaking last week to discuss its FY2021 Q2 results, CEO Nick Green did not dismiss the idea of expanding its capabilities further afield. “We…

KBI adds $150m commercial facility alongside pharma partner

by Ben Hargreaves

KBI Biopharma will establish a commercial manufacturing facility in North Carolina with a co-investor, due to be operational Q1 2022. The contract development and manufacturing organization (CDMO) is developing the facility alongside an unnamed pharmaceutical partner to support the manufacture of the latter’s therapeutic protein programs. KBI will provide current good manufacturing practice (cGMP) biologics manufacturing for the partner, with a spokesperson for KBI Biopharma confirming that this would represent a “significant amount of [total] capacity.” However, the site will…

Lonza building dedicated conjugation suites for ADC client

by Dan Stanton

The two dedicated suites in Visp, Switzerland will support commercialized antibody-drug candidates (ADCs) products for an undisclosed biopharma customer. Contract development and manufacturing organization (CDMO) Lonza has announced 1500 m2 of active manufacturing space will be dedicated to the biopharma customer, in addition to established quality control (QC) labs, logistics and other central services, to Charles Christy, head of Commercial Solutions Ibex Dedicate, Lonza, told us the customer has asked for confidentiality and so details are scarce, but the firm…

Germany’s Merck teams with Siemens to ‘digitalize’ production

by Dan Stanton

Merck KGaA will construct a €10 million ($12 million) modular plant at its site in Darmstadt, Germany as part of a collaboration with Siemens for the digitalization of production. The partnership aims to advance the development of a process control system for the manufacture of Merck’s products – including biopharmaceuticals and life science tools – by using Siemens’ tech platforms for the joint development of an overall system for automating the modular production. “We are able to setup any kind…

AGC Biologics doubling Danish capacity in $192m expansion

by Dan Stanton

Construction of a 19,000m2 facility at its site in Copenhagen is the latest example of the CDMO’s growth strategy. In February 2017, Japan’s AGC Asahi Glass (AGC) acquired CMC Biologics, a contract development and manufacturing organization (CDMO) with facilities in Seattle, Washington, and Copenhagen, Denmark. Later that year, the firm rolled out an expansion at the Danish site adding five 2,000 L single-use bioreactors to be run in single unit operations or in unison. In 2018, the CDMO – now…

mRNA vaccine: Pfizer’s inhouse approach vs Moderna’s use of third parties

by Dan Stanton

Though not heavily reliant on external suppliers, Pfizer is taking a higher distribution risk than Moderna and CureVac due to making its mRNA vaccine inhouse, says research firm Third Bridge. Earlier this month, both Pfizer and Moderna reported Phase III trial data showing their respective messenger RNA (mRNA) vaccines were above 90% effective against COVID-19. Pfizer submitted an Emergency Use Authorization (EUA) application with the US Food and Drug Administration (FDA) earlier this month, and Moderna is doing so today.…

Mustang expands ‘bubble boy’ gene therapy footprint with European CDMO

by Dan Stanton

Mustang Bio has established a European manufacturing base for its lentiviral gene therapy candidate MB-107 through a deal with cell and gene therapy CDMO Minaris. Developed with St. Jude Children’s Research Hospital, MB-107 is Mustang Bio’s lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. The candidate, which received US FDA Orphan Drug Designation in September, is manufactured from a facility in Worcester, Massachusetts but the firm is now looking outside…

Pharming doubling downstream capacity for commercial HAE therapy

by Dan Stanton

Pharming Group will build a facility at its site in Oss, the Netherlands to increase downstream manufacturing capacity for Ruconest, a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with hereditary angioedema (HAE). Dutch pharma firm Pharming is building a new facility to expand downstream processing capacity at its site in Pivot Park, Oss. Once operational, the facility will carry out the purification, filtration and concentration of the starting material for lead product Ruconest…

Samsung Bio in $150m deal to make COVID antibodies for Lilly

by Dan Stanton

Korean CDMO Samsung Biologics will produce COVID-19 antibody therapies for Eli Lilly as it signs another multi-hundred-million-dollar contract with a Big Pharma firm. Eli Lilly originally approached contract development and manufacturing organization (CDMO) Samsung Biologics in May as it looked to secure capacity for its range of potential COVID-19 treatments. Samsung was able to manufacture and deliver an initial supply of Active Pharmaceutical Ingredients (API) within five months, and as such the CDMO has become a strategic partner for Eli…

Iovance plant on track for 2022 and lifileucel BLA set for next year

by Gareth Macdonald

Iovance Biotherapeutics says its new cell therapy plant in Philadelphia is on track to begin commercial production in 2022. The firm updated on development of the facility at the Navy Yard complex in Philadelphia during its Q3 earnings call, telling analysts clean rooms are due to be operational for clinical trial supply production in 2021. Iovance announced plans for the $125 million Philadelphia facility in May last year, explaining it would be used to make autologous TIL products including lifileucel…