Author Archives: Dan Stanton

Catalent clears up FDA 483 concerns at Indiana plant

by

The plant in Bloomington received a Form 483 with five observations in May, but Catalent says a second US FDA inspection shows issues have been resolved. The US Food and Drug Administration (FDA) recently published a Form 483 it issued to Catalent’s biomanufacturing facility in Bloomington, Indiana following an inspection in April and May this year. The Agency made five observations at the 875,000ft2 production and fill/finish facility, which the contract development and manufacturing organization (CDMO) gained as part of…

September 14, 2018

Biocad teams with SPH to build Chinese biomanufacturing plant

by

Russian drugmaker Biocad and Shanghai Pharmaceuticals Holding (SPH) have formed two joint ventures to develop and make originator and biosimilar antibodies in China. At the Eastern Economic Forum (EEF), a memorandum of understanding has been signed between the two companies, establishing two joint ventures aimed at developing and manufacturing several monoclonal antibodies intended for the Chinese market. “The project itself is focused on four molecules and two original products,†Biocad spokesperson Irina Kenyukhova told BioProcess Insider. “Due to the fact…

September 13, 2018

Exclusive: Samsung BioLogics poised to enter cell therapy space

by

After building three large-scale biomanufacturing plants, CDMO Samsung BioLogics has told BioProcess Insider it is adding single-use capacity and is considering expanding into stem cell therapy services. It has been nine years since Samsung BioLogics entered the third-party biologics space, in which time it has brought two commercial biomanufacturing facilities online with a third expected to be fully validated by the end of this year. When operational, the firm’s site in Incheon, South Korea will boast a total of 362,000…

September 12, 2018

Sanofi deal shows demand for CHO alternatives, says Dyadic

by

Sanofi-Aventis Deutschland has teamed with Dyadic to test the potential of the C1 fungus-based expression system for the manufacture of biologics and vaccines. The fully funded proof of concept research deal will see Sanofi-Aventis use Dyadic International’s C1 platform to overcome specific gene expression challenges across some of its vaccine and protein-based biologics “Sanofi sees huge value in C1 and the future of bioprocessing and biomanufacturing efficiencies with such a power horse and we are excited for the collaboration as…

September 12, 2018

Thermo Fisher back on the M&A train through BD buy

by

The addition of BD’s Advanced Bioprocessing business will boost Thermo Fisher Scientific’s cell culture media formulations offering. At the BioProcess International Conference in Boston, Massachusetts last week, news broke that equipment and reagent supplier Thermo Fisher agreed to buy the Advanced Bioprocessing business of medtech firm Becton, Dickinson and Company (BD). The business, which clocks in around $100 million (€86 million) annually, will add several peptones that enhance cell culture media formulations, aimed at improving yield and reduce variability in…

September 11, 2018

Sanofi prepped for production after EU Nanobody success

by

Ten weeks after acquiring Ablynx, Sanofi has received European approval for lead Nanobody-based drug Cablivi (caplacizumab). In June this year, Sanofi acquired Belgian biotech Ablynx for €3.9 billion ($3.5 billion), adding the firm’s pipeline of biotherapeutics based on the small-sized antibody, or Nanobody, technology. Now the French biopharma firm is set to commercialize lead product caplacizumab (anti-vWF Nanobody) in Europe under the brand name Cablivi after the European Commission granted it marketing authorization for the treatment of rare blood-clotting disorder…

September 10, 2018

BioMarin building $50m Irish fill/finish plant for orphan enzymes

by

The drug product plant in County Cork will support the fill and finish of BioMarin’s rare disease drugs Vimizim (elsulfase alfa) and Brineura (cerliponase alfa). The filling facility at BioMarin’s site in Shanbally, County Cork represents an investment of €43 million ($50 million) and will create 51 additional jobs. “We regularly evaluate our manufacturing capabilities and which capabilities we do ourselves and which make sense to outsource,†BioMarin spokesperson Debra Charlesworth told BioProcess Insider. “Based on our current business needs…

September 10, 2018

Vendors ‘awakening’ to the needs of cell and gene therapy makers

by

Equipment suppliers are vying to fill gaps in processing say cell and gene therapy experts, but understanding what end-users need will be central for success. In 2017, the US FDA approved two chimeric antigen receptor T (CAR-T) cell therapies. Since then there have been several other cell and gene therapies approved across several markets, including Europe’s first allogeneic stem cell in the form of Takeda’s Alofisel (darvadstrocel). And with several hundred cell and gene candidates moving through the clinical stages…

September 6, 2018

Sartorius combination tech deal a ‘win-win,’ says Repligen

by

Bioprocessing vendors Sartorius Stedim Biotech and Repligen Corporation have combined their bioreactor technologies to offer control integrated bioreactors for perfusion. Announced at the BioProcess International Conference in Boston this week, Sartorius and Repligen have inked a deal to integrate their respective technologies into a combined offering for biomanufacturers. Under terms of the deal, Repligen’s XCell ATF cell retention control technology will be combined into Sartorius’ BIOSTAT STR large-scale single-use bioreactors offering customers bioreactors used in perfusion cell culture applications between 50…

September 5, 2018

False biosimilar communications: Originators rebuff Pfizer’s claims

by

Pfizer has accused Amgen, J&J and Roche of sending misleading communications about biosimilars in a Citizen Petition asking the US FDA to issue guidance on such behavior. In a Citizen Petition published on August 22, Pfizer said communication tools intended to incentivize the adoption of and switching of biosimilars have led to a robust uptake of biosimilars in Europe, but in the US “payer reimbursement policies are in fact impeding adoption of biosimilars.†The firm continued: “Dissemination of false or misleading…

September 4, 2018