Therapeutic Class Archives - Page 34 of 53 - BioProcess InternationalBioProcess International

FDA issues draft guidance on biosimilar analytical studies

The draft guidance advises industry to minimize differences between a biosimilar and its reference biologic including in the choice of expression system and manufacturing process. The US Food and Drug Administration (FDA) has been active in encouraging biosimilar development of late, publishing its long-awaited interchangeability guidance earlier this month. In its latest push the Agency has issued draft guidance entitled: ‘Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry.’ The document makes recommendations on…

Off-the-shelf CAR-T a ‘gamechanger’ for multiple myeloma, says Allogene

by Dan Stanton

Allogene expects manufacturing specifications to be a focus of IND reviews as it looks to bring an off-the-shelf CAR-T therapy for multiple myeloma through the clinic. Chimeric antigen receptor (CAR) T-cell therapies have been described as “one of the newest, emerging weapons in the fight” against multiple myeloma, a cancer affecting around 300,000 Americans every year. Some of the candidates in the clinic for multiple myeloma include Bluebird and Celgene’s BB21217, Celgene’s JCARH125 and Janssen/Legend Biotech’s LCAR-B38M, but these –…

Cryoport acquires Cryogene for $20.5m, adds Texas biostorage site

by Dan Stanton

The combination of cold-chain logistics and biostorage places Cryoport in good stead for the arrival of allogeneic cell therapies, an analyst says. Cryogene’s proximity to Lonza’s Houston site is also a boon. Cryoport, a provider of temperature-controlled logistics solutions specifically in the cell and gene therapy space, paid $20.5 million (€18.3 million) in cash for Houston, Texas-based biostorage and biobanking firm Cryogene. Cryogene brings a 21,000 square-foot biostorage facility – which specializes storing biological specimens, materials and samples – to…

ElevateBio proposes centralized model for cell & gene startups

by Dan Stanton

Neither a CDMO nor an end-user, ElevateBio is looking to change the paradigm in cell and gene therapy development through it’s a centralized R&D and manufacturing model. Recently launched through a $150 million (€134 million) Series A financing, ElevateBio intends to create and grow a portfolio of cell and gene therapy companies using shared expertise and facilities through its R&D, process development and cGMP manufacturing subsidiary Basecamp. “BaseCamp is not a CDMO [contract development and manufacturing organization],” ElevateBio’s CEO David…

MilliporeSigma and Thermo contribute to Biolife’s ‘blowout’ Q1

by Dan Stanton

Distributors STEMCELL Technologies and VWR also cited as sales of Biolife Solutions’s bio-preservation media and automated thawing products increased 51% year-on-year. For the first quarter 2019, Biolife, which makes and supplies biopreservation media and automated cell thawing media devices for cell and gene therapies, reported record revenues of $5.8 million (€5.2 million). “Dead cells don’t cure cancer, and the combined therapeutic, and economic risks our customers are facing should broaden use of our products as a best practice in the…

Pfenex ready to play in next wave smaller biologics

by Dan Stanton

As industry looks to smaller sized proteins and engineered scaffolds, Pfenex believes its expression technology will make it a significant player in the space. For its first quarter 2019, Pfenex reported a 177% jump in revenues year-on-year to $10.4 million (€9.2 million), attributed to milestone payments and recognition of deferred revenues from its PF708 partners, and increased sales of its CRM197 product. Lead program PF708 is a recombinant protein form of parathyroid hormone with a PDUFA date of October 7.…

Alnylam: ‘Onpattro will springboard us into a global biopharma firm’

by Dan Stanton

Alnylam says it is on course to becoming “a global multiproduct commercial biopharma company” by 2020 as sales of its messenger RNA interference therapeutic Onpattro (patisiran) begin to ramp-up. Alnylam Pharmaceuticals made history in August 2018 when Onpattro (patisiran), its product for the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis, became the first small interfering ribonucleic acid (siRNA) treatment to be approved by the US Food and Drug Administration (FDA). Reporting its first quarter 2019 financials, the firm described the milestone…

Buoyed by CGT growth, Bio-Techne plans plant to supply $200m of reagents

by Dan Stanton

Bio-Techne will invest $40 million to construct a GMP facility in Minneapolis expected to feed the growing demand for reagents in the cell and gene therapy space. The life sciences services and consumables firm reported a 12% growth in sales year-on-year in its third quarter FY2019 within its Protein Sciences segment. The segment – which supplies proteins such as cytokines and growth factors, immunoassays, antibodies and reagents to the biopharma industry – pulled in $138 million in the quarter. Its…

Gilead lets Kite fly solo to compete in competitive CAR-T space

by Dan Stanton

Giving cell therapy unit Kite autonomy will “foster agility, innovation and entrepreneurialism,” says recently appointed Gilead CEO Daniel O’Day. Gilead Sciences entered into the advanced therapy space in August 2017 through the $11.9 billion (€10.6 billion) acquisition of Kite. Just weeks later, the firm saw regulatory success with Yescarta (axicabtagene ciloleucel), which became the second chimeric antigen receptor (CAR) T-cell therapy to be commercialized in the US. Close to two years on, the firm has announced it intends to run…

Breathing space: Inhalable biologics interest prompts Intertek expansion

by Gareth Macdonald

Interest in inhaled biologics is increasing says Intertek, which has announced plans to expand its testing facility in Melbourn, near Cambridge. Intertek will double capacity with a new 20,000 square-foot lab kitted out with technologies use to assess inhaled and nasal formulations of large molecule drugs. It also plans to hire 100 employees over the next four years. “As companies are increasingly looking at biologics for non-invasive delivery platforms like inhaled and nasal, there is expected to be an increased…