Regulations

Biogen Alzheimer’s mAb approval to be a boon for bioprocess space

The approval of Aduhelm (aducanumab) will have a significant knock-on effect for the bioproduction services space, increasing the annual growth rate several percentage points. Yesterday, the US Food and Drug Administration approved Aduhelm ending years of regulatory turbulence for Biogen. The drug, a monoclonal antibody that breaks down amyloid plaque buildup that is thought to worsen Alzheimer’s disease, marks a turning point in Biogen’s fortunes. The firm has seen falling revenues as competition challenges its lead products – Tecfidera (dimethyl…

Alvotech latest to challenge AbbVie on US Humira exclusivity

AbbVie is confident that no biosimilar will challenge Humira sales in the US until 2023 despite a legal challenge from Alvotech seeking to end the monopoly. Humira (adalimumab) is the world’s top selling drug, pulling in $19.8 billion in revenues for AbbVie in 2020. Of this, $16.1 billion was from the US, a region currently protected from adalimumab competition due to AbbVie’s web of patents and legal agreements with numerous biosimilar makers. But while the likes of Amgen, Samsung Bioepis,…

Biogen Swiss site GMP ready for aducanumab launch

Biogen has received GMP certification at its Solothurn, Switzerland facility ahead of a regulatory decision for potential Alzheimer’s drug aducanumab. Biogen commissioned the CHF 1 billion ($1 billion) monoclonal antibody production facility in Luterbach, Solothurn, in 2015, stating at the time it would offer 144,000 L of stainless-steel capacity, comprising of eight 18,000 L bioreactors with an output of 10 metric tons. Last week, Swiss Agency for Therapeutic Products (SWISSMEDIC) granted the facility a Good Manufacturing Practice (GMP) multi-product license,…

Bluebird welcomes CHMP nod for CALD gene therapy

Bluebird Bio says Skysona – a treatment for the neurological disease CALD – is a step closer after a thumbs-up from EMA reviewers. The European Medecines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the therapy and issued an approval recommendation last week. The CHMP said the advice was based on a study in which Skysona (elivaldogene autotemcel, formerly Lenti-D) preserved motor function and communication ability and improved survival in 90% of patients…

GMP deficiencies disrupt production of ERC’s cell-based vaccine

European regulators have suspended the distribution of autologous and allogeneic cell-based vaccine candidate Gliovac following an inspection at ERC’s site in The Netherlands. The inspection took place on February 25 at the Schaijk facility, located about 75 miles southeast from Amsterdam, and resulted in a statement of non-compliance with good manufacturing practice (GMP) being issued. “ERC The Netherlands B.V. showed a lack of ability to adhere to the principles of Good Manufacturing Practice for ATMPs [advanced therapy medicinal products],” the…

Emergent recognized cross contamination risk at Bayview plant hit with 483

Emergent BioSolutions has defended the manufacture of two different viral products from its Bayview facility as part of the “Herculean task” of tackling the coronavirus pandemic. The Bayview, Maryland drug substance facility has been on the forefront of the fight against COVID-19, with Emergent BioSolutions contracted to make millions of doses of Johnson & Johnson and AstraZeneca’s respective vaccines from the plant. But an ingredient mix up reported in March rendered 15 million doses unusable, and Emergent has now halted…

Lonza’s alleged need for Nestlé staff highlights shortage in biopharma talent

Neither company will confirm reports that NestlĂ© staff have been commandeered to help Lonza service its Moderna contract but the story highlights biomanufacturing staffing issues. A report by Reuters this week claims contract development and manufacturing organization (CDMO) Lonza is adding staff from fellow Swiss firm NestlĂ© in order to service a deal to produce drug substance for hundreds of millions of doses of Moderna’s COVID-19 vaccine. The “call for volunteers” following an intervention by the Swiss government aims at…

ADC Therapeutics joins conjugate elite with Zynlonta FDA approval

The US FDA has approved Zynlonta (loncastuximab tesirine), the eleventh antibody-drug conjugate and the first for ADC Therapeutics. Zynlonta received the thumbs up from the US Food and Drug Administration (FDA) last week for the treatment of patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The antibody-drug conjugate (ADC) is composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD)-based cytotoxic warhead. PBDs are a class of compounds…

Emergent issues: FDA orders production halt at Bayview plant

COVID-19 vaccine contract manufacturer Emergent BioSolutions has stopped production at its beleaguered Bayview, Maryland plant following a US FDA inspection that led to a Form 483 with nine observations. The US Food and Drug Administration (FDA) began an inspection at the Bayview site in Baltimore, Maryland on April 12 and, according to Emergent, four days later requested a manufacturing hold. “On April 16, 2021, at the request of the FDA, Emergent agreed not to initiate the manufacturing of any new…

BARDA to give Emergent another $23m for tech after J&J jab mix-up

BARDA to give Emergent Biosolutions an extra $23 million for new tech after plant mix up ruined millions of doses of J&J’s single-shot COVID vaccine. The facility in question is Emergent’s plant in Baltimore, Maryland which made the news after it emerged the contract development and manufacturing organization (CDMO) had mistakenly mixed ingredients of the J&J jab with those of the AstraZeneca shot, rendering 15 million doses unusable. The incident prompted the Biden administration to place Johnson & Johnson in…