Author Archives: Dan Stanton

Trouble choosing? BrevisRefero launches CDMO proposal platform

BrevisRefero has launched a Request For Proposal (RFP) platform aimed at helping biopharma better select its third-party manufacturing partners. The pharma world has for years relied on outsourcing partners. Contract research organizations (CROs) are used to carry out clinical trials, third parties manage transport and logistics, and of course contract development and manufacturing organizations (CDMOs) support production of nearly every component of the drug production process. Now the biopharma space can outsource the outsourcing process itself, through an online RFP…

Vaccines, plasma and stem cells: How industry hopes to take on COVID-19

The biopharma space has stepped up its efforts to both prevent and treat the coronavirus (SARS-CoV-2) that is threatening to bring the world to its knees. A month is a very long time when it comes to infectious diseases. The first cases and deaths from the novel coronavirus (COVID-19) led to a response to contain the virus, but the difficulties of containment and the nature of international travel means cases and deaths have become global. The latest statistics place the…

Coherus eyes ophthalmology biosimilars prize

In-licensing a Lucentis biosimilar goes “hand-in-hand” with its internally developed Eylea biosimilar, says Coherus BioSciences. Californian biosimilar developer Coherus acquired the US commercial rights in November to commercialize a version of Lucentis (ranibizumab) from Bioeq, a joint venture between Polpharma Group and Strüngmann Group. The ophthalmic monoclonal antibody pulled in US sales of CHF 1.83 billion ($1.9 billion) for Roche/Genentech in 2019. Concurrently, Coherus has a biosimilar candidate looking to take on Regeneron’s Eylea (aflibercept) in the form of CHS-2020.…

Halozyme eyes major drivers in Roche and Janssen subcutaneous approvals

Potential upcoming approvals and launches of subcutaneous formulations of monoclonal antibodies could prove a boon for Halozyme, which licenses its Enhanze technology to Janssen and Roche, among others. In 2019, Halozyme Therapeutics announced its pancreatic cancer drug candidate PEGPH20 did not meet a Phase 3 study’s main goal of improving how long patients lived. As such, the firm laid plans to restructure, ending its R&D oncology operations in favor of growing its formulation platform offering, Enhanze. The technology consists of…

Fujifilm breaks ground at $54m NC biologics plant expansion

The expansion at a cell culture facility in Research Triangle Park will feed the demand for growing biologics pipelines, says CDMO Fujifilm Diosynth Biotechnologies. Contract development and manufacturing organization (CDMO) Fujifilm broke ground on a 31,778 square-foot extension at its site in Research Triangle Park, Morrisville, North Carolina, which will add recovery and purification suites to support biomanufacturing. The firm says it will increase its cell culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50% when the…

Repligen up on OPUS and gene therapy demand

Repligen says it will continue to expand capacity to feed demand for its OPUS range of prepacked chromatography columns. For the full year 2019, revenues at bioprocess vendor Repligen Corporation came in at $270 million (€250 million), up from $194 million in 2018. Revenues grew across all the firm’s divisions, with organic growth of 20%, 30% and 40% for Repligen’s proteins, filtration and chromatography franchises, respectively. And within the chromatography franchise, the firm’s OPUS range of prepacked chromatography columns stood…

AveXis ‘flexible’ NC plant a step closer to fully internal gene therapy network

AveXis has opened a gene therapy plant in Durham it says will be able to produce up to seven products simultaneously. President Dave Lennon talks timelines, capacity, and taking production inhouse. AveXis and its owner Novartis have invested a total of $115 million (€106 million) into a site in Durham, North Carolina to support the production of US Food and Drug Administration (FDA) approved product Zolgensma (onasemnogene abeparvovec) and its pipeline of gene therapy candidates. With the doors opening last…

Another WuXi Vaccines deal? No, just a repurposed press release

Contrary to some reports, WuXi Biologics is not building a second facility for its recently formed vaccines joint venture but has merely secured the $3 billion contract announced last May. Nine months ago, WuXi Biologics and Shanghai-based Hile Bio-Technology formed WuXi Vaccines, a contract development and manufacturing organization (CDMO) to service a Letter of Intent (LOI) inked with an undisclosed multinational vaccine company. In November, plans were laid to build a $240 million (€222 million) three-story dedicated manufacturing facility in…

KKR pumps €50m into Univercells through Gamma funding platform

Over a quarter of Gamma Bioscience’s $200 million funding for next-generation bioprocessing technologies will be used to support Univercells’ biomanufacturing tech platforms. In January, global investment firm KKR launched Gamma Bioscience, a portfolio of life sciences tools subsidiaries. The first company to fall under the umbrella was Astrea Bioseparations, a ligand discovery and adsorbent development services firm, previously known as Prometic Bioseparations, acquired by KKR for around $100 million (€93 million) in November 2019. Now KKR and co-investors have committed…

Audentes $109m NC expansion boon for Astellas gene therapy plans

Astellas acquisition Audentes has laid plans to build a 135,000 square-foot gene therapy manufacturing plant in Sanford, North Carolina. The $109 million (€100 million) plant is expected to be operational in 2021 and will support Audentes’ gene therapy portfolio. The firm’s lead product is AT132, a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM), though the firm is also developing gene therapies for Pompe disease and Duchenne Muscular Dystrophy (DMD). “Our investment in large-scale manufacturing has always been…