Facilities & Capacity

CEO changing, but Avid continues its versatile CDMO strategy

Having relaunched itself in 2018, Avid Bioservices says it is going from strength-to-strength in the contract manufacturing space and its strategy will continue with a new CEO. Avid Bioservices emerged from drug developer Peregrine Pharmaceuticals in January 2018 as a pureplay contract development and manufacturing organization (CDMO). “While we were a product development organization, we also had manufacturing facilities to support the manufacturing of our pipeline. While we were focused on developing products, we were also offering our services for…

Catalent to invest up to $10m into ex-BMS fill/finish site

Catalent will retain all 700 staff and invest up to $10 million into a site in Italy it is acquiring from Bristol-Myers Squibb. The deal, announced this week, will see the contract development and manufacturing organization expand its biologics network outside of the US through the addition of a sterile product manufacturing and packaging facility in Anagni, Italy. Financial details regarding Catalent’s first biologics manufacturing facility in Europe have not been divulged, but a spokesperson told this publication the CDMO…

Lonza building capacity for Gamida’s bone marrow transplant

Lonza will construct suites at its site in The Netherlands dedicated to producing Phase III and commercial supply of Gamida’s bone marrow transplant cell therapy omidubicel. Lonza has produced clinical supply of omidubicel for Gamida but the strategic deal announced today will see the Swiss contract development and manufacturing organization (CDMO) fulfil the future commercial supply from its site in Geleen, The Netherlands. Formerly known as NiCord, omidubicel is the Massachusetts-based cell therapy firm’s lead candidate, currently in Phase III…

Middle class: Lonza on the flexibility of midscale biomanufacturing

With construction of a 6,000 L scale hybrid plant underway, CDMO Lonza says there is high demand among its customers for midscale biomanufacturing. In this industry, companies and commentators like talking about extremes: either small-scale single-use or large-scale stainless steel. But speaking at the BPI Theater at BIO in Philadelphia earlier this month, Stéphane Varray, commercial development for midscale at Lonza Pharma and Biotech said midscale options provide firms with flexibility across numerous modalities. “When we look at midscale we’re…

Fujifilm tackles buffer bottleneck at $10m continuous processing plant

Fujifilm Diosynth Biotechnologies says it can overcome the burden of large buffer volumes associated with continuous purification as part of a new UK processing facility. The facility in Billingham, UK will include a 500 L single-use perfusion bioreactor and 7 downstream processing units and is expected to begin offering process development later this year. The plant represents a $10 million (€8.9 million) investment by the contract development and manufacturing organization (CDMO) and is the culmination of three years of in-house…

Hitachi supplying gene therapy Zynteglo for bluebird in EU

bluebird bio will use Hitachi Chemical subsidiary apceth Biopharma to commercially manufacture its recently EU approved gene therapy Zynteglo. Earlier this month, the European Medicines Agency (EMA) approved orphan drug Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – previously known as LentiGlobin – as a one-off treatment for beta-thalassaemia. Zynteglo uses a lentiviral viral vector to add functional copies of a modified β-globin gene into a patient’s own stem cells, addressing the underlying genetic cause of patients for whom a…

Californian sun and $1.5m investment help ATUM go green

Switching to renewable energy sources reduces the biomanufacturing industry’s contribution to global warming, saves money and is relatively easy to do, says ATUM. Life sciences services firm ATUM has completed the installation of 26,000 square feet of solar paneling at its production site in Newark, California. The $1.5 million (€1.3 million) project give the site the ability to run on 100% solar power. The decision to go green plays into the founders’ ethos to build a company with a long…

Inside Jefferson: $7m bioprocess training institute opens in PA

The Jefferson Institute for Bioprocessing (JIB) has opened its doors in Pennsylvania. Bioprocess Insider visited to find out how the site, supported by Ireland’s NIBRT and GE Healthcare, will aid the bioprocess industry. In June 2018, plans were laid down for a site in Pennsylvania for an education and training institute to support the staffing gaps in the bioprocessing space. A year on, the Jefferson Institute for Bioprocessing (JIB) has opened, with help from a $7 million (€6.2 million) investment…

Bavarian Nordic considers turning CMO as it builds out network

“Having manufacturing capabilities is both a blessing and a noose around your neck,” says Bavarian Nordic as it considers CMO opportunities. Bavarian Nordic has expanded its manufacturing footprint over the past few years, including expanding its bulk vaccine capabilities and adding a fill/finish facility in Kvistgaard, Denmark. The $75 million fill/finish plant is on track to be finalized by the end of the year, with production expected to begin in 2021. The growth of its manufacturing network will support its…

REGENXBIO building Maryland AAV plant to support gene therapies

REGENXBIO will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform. The good manufacturing practice (GMP) plant will be integrated into REGENXBIO’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021. “The creation of this additional manufacturing capacity using our platform suspension cell culture process will allow us to more efficiently…