Author Archives: Dan Stanton

Bayer launches CGT unit on back of Bluerock and AskBio acquisitions

Having closed its $2 billion acquisition of Asklepios BioPharmaceutical (AskBio), Bayer has established a cell and gene therapy platform. The Cell and Gene Therapy (C&GT) Platform within Bayer’s Pharmaceuticals division aims to bring various acquisitions, capabilities, and assets together. According to the firm, the unit “will provide an innovation ecosystem within which the different participating partners, whether they be independent companies or strategic collaborators, can operate most effectively. They keep and further develop their passion and biotech spirit, scientific leadership…

Lonza building dedicated conjugation suites for ADC client

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

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

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

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

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…

Roche licenses cell line-based AAV vector tech from CEVEC

Roche will access an adeno-associated virus (AAV) vector manufacturing platform for its gene therapy portfolio in a deal CEVEC says validates its ELEVECTA technology. The deal, financials of which have not been disclosed, will see Swiss pharma giant Roche use CEVEC’s ELEVECTA Technology for AAV vector manufacturing across its gene therapy portfolio, including products being developed by its acquisition Spark therapeutics. ELEVECTA, launched in April this year, is a platform that allows for the large-scale production of AAV vectors from…

Pharming doubling downstream capacity for commercial HAE therapy

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

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…

Pfizer looks to freezer farms and thermal shippers to make COVID vaccine distribution ‘doable’

Pfizer says it is prepped to overcome the logistical challenges of distributing its mRNA vaccine against COVID-19 as it submits an Emergency Use Authorization (EUA) to the US FDA. Today, Pfizer submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of BNT162b2, an mRNA vaccine candidate codeveloped with Germany’s BioNTech, against SARS-CoV-2. The news follows Phase III trial data showing the vaccine has an efficacy rate of 95% and marks a major milestone…