Regulations Archives - Page 13 of 27 - BioProcess InternationalBioProcess International

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

by Gareth Macdonald

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…

CDMO and COVID delays push back Vaxcyte’ pneumococcal vaccine IND

by Gareth Macdonald

Vaxcyte will file VAX-24 pneumococcal conjugate vaccine later than planned citing capacity constraints at CDMO Lonza and the COVID-19 pandemic. The California biotech had intended to file the vaccine for US FDA review early this year, however, according to its Q4 results presentation, submission is now planned during the first half of 2022. Vaxcyte said it expects to submit an IND application “between January and June 2022 and plans to announce top-line data from the ensuing Phase I/II clinical study…

BIO: Sputnik V should be judged on same data as other COVID jabs

by Gareth Macdonald

Russia’s Sputnik V COVID-19 vaccine should be judged by the same safety and efficacy standards applied to jabs made by Moderna, Pfizer, AstraZeneca, and J&J according to industry group BIO. The Amsterdam-based EMA began reviewing the vaccine – also called Gam-COVID-Vac – last week after R-Pharm Germany GmbH submitted an approval application. A spokeswoman told us “The CHMP’s decision to start the rolling review of the Sputnik V COVID-19 vaccine is based on results from laboratory studies and clinical studies…

Busulfan not likely cause of Bluebird Bio trial SAEs says CRISPR Therapeutics

by Gareth Macdonald

CRISPR Therapeutics says the conditioning agent busulfan is unlikely to be the cause of adverse events that prompted Bluebird Bio to halt LentiGlobin trials. As a medicine busulfan is used to treat chronic myelogenous leukemia. It works by slowing or stopping the growth of cancerous cells. It is also used in cell and gene therapy as a conditioning agent to destroy bone marrow to prepare patients for transplant. Busulfan hit the headlines this month after Bluebird Bio started investigating it as…

Busulfan role in Bluebird’s woes could impact gene therapy sector

by Gareth Macdonald

Cell and gene therapy developers will have a close eye on cancer cases linked to Bluebird Bio’s LentiGlobin, say analysts. Earlier this month Bluebird halted two trials of LentiGlobin in sickle cell disease – specifically HGB 206 NCT02140554 and HGB 210 NCT04293185. It said the decision was prompted by a case of acute myeloid leukemia (AML) in a patient in group A of the Phase I/II HGB-206 study and a case of myelodysplastic syndrome (MDS) in a patient in Group C of the…

COVID-19 MAbs should be made with combination in mind says US FDA

by Gareth Macdonald

Monoclonal antibody (mAb) manufacturers aiming for an EUA should prepare for their SARS-CoV-2 therapies to be combined with others, according to the US FDA. The US regulator issued the advice in guidance this week in which it also urged developers to collaborate and share data. The FDA said, “Strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes to minimize the…

Bluebird Bio investigating potential vector role in AML and MDS cases

by Gareth Macdonald

Bluebird Bio’s suspension of trials of its sickle cell gene therapy LentiGlobin has put the vector used to make it in the spotlight. The US biotech announced the temporary suspension of two LentiGlobin trials – specifically HGB 206 NCT02140554 and HGB 210 NCT04293185 – this week. It said the measure was prompted by reports a patient in group A of the Phase I/II HGB-206 study treated with the therapy five years ago had developed acute myeloid leukemia (AML). Bluebird also…

BMS gearing up to make Breyanzi at Bothell cell therapy plant

by Gareth Macdonald

Bristol Myers-Squibb (BMS) has set a 24-day production target for Breyanzi and set up a digital platform to let physicians and patients track manufacture of the lymphoma cell therapy in real-time. The US Food and Drug Administration (FDA) cleared Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma this month. A BMS spokeswoman told us “BMS plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facilities, initially…

Podcast: Systemic racism in the biomanufacturing space

by Dan Stanton

Black and minority workers are consistently overlooked in the biomanufacturing industry due to unconscious – or perhaps conscious – racism, LucasPye Bio CEO Tia Lyles-Williams explains in The BioProcess Insider Expression System podcast. In the first episode of this new podcast series, Tia-Lyles Williams, CEO of LucasPye Bio, talks about diversity in the biopharma workplace and the hurdles that continue to hold back black and minority workers. Tia now leads a Philadelphia-based CDMO that recently raised $50 million in funding…