CDMO Oligo Factory has increased its oligonucleotide synthesis capability 12-fold through the opening of a 13,000 square-foot facility in Holliston, Massachusetts. The facility – which opened its doors earlier this month and represents over $1 million in customized hardware and unique buildout – consists of bench space, offices, and labs for Oligo Factory’s next generation of synthesizers, and significantly ups its manufacturing capacity. Oligo Factory delivers oligos for several markets, including functional genomics, diagnostics, and therapeutics. The growing demand drove…

CDMO Lonza will integrate Simris’s antibody-drug conjugate (ADC) payload technology into its bioconjugation services. Swedish biotech Simris Biolgics, previously known as Cyano Biotech, has entered a strategic partnership to make contract development and manufacturing organization (CDMO) Lonza its preferred partner for the commercialization of its ADC payload platform. Under terms of the deal, financials of which have not been divulged, Lonza will gain the exclusive right to offer the technology to customers seeking payloads to develop into ADCs, while Simris…

RNA vaccine manufacturing has lower CAPEX but higher operational costs than AVV vaccine production, says an expert at BPI West.   Messenger (mRNA) was thrusted into the limelight through the success of Moderna and BioNTech/Pfizer’s respective COVID-19 vaccines. Their approvals have helped bring confidence to the mRNA sector and drive investment in wider RNA technology platforms.  But despite its success, the RNA space still has many challenges to overcome and comparisons to other modalities are heavily debated. Zoltan Kis, lecturer at…

Maxion Therapeutics’ $16 million Series A financing round will be used to develop biologics targeting ion channels and GPCRs via its KnotBody platform. Cambridge, UK based firm Maxion said ion channels and G-protein-coupled receptors (GPCRs) are essential cell surface proteins, which can be used to treat a range of diseases, including chronic pain and autoimmune conditions. The Series A funding round, led by LifeArc Ventures, BGF, and Monograph Capital, will support the advancement of Maxion’s KnotBody platform. To date, small…

Other hemophilia B gene therapy developers are looking to learn from CSL as it preps to launch the $3.5 million product in the US, the firm says. In December 2022, CSL Behring won US Food and Drug Administration (FDA) approval for its one-time gene therapy Hemgenix (etranacogene dezaparvovec). The single-dose therapy treats adults with hemophilia B – a rare bleeding disorder caused by a gene defect that results in insufficient production of blood clotting protein factor IX – and has…

Students in Birmingham, UK are being trained in the production and administration of cell and gene therapies (CGTs) using virtual reality software. BioProcess Insider spoke with Professor Ivan Wall, co-founder and CEO of FourPlus Immersive, to find out more. Wall’s company produces virtual reality (VR) software that students and biopharmaceutical industry professionals use to train in good manufacturing practices (GMPs), which recreates the hands-on experience of cleanroom manufacturing. Apprentices train at the National Training Centre for Advanced Therapies Manufacturing at…

Bristol Myers Squibb will continue to expand vector and drug product capacity for Abecma and Breyanzi but says manufacturing success is just as essential in ensuring supply. For the full year 2022, Bristol Myers Squibb (BMS) reported its chimeric antigen receptor (CAR) T-cell therapies Abecma (ide-cel) and Breyanzi pulled in $388 million and $182 million, respectively – up from $164 million and $87 million the year prior. While full year comparisons are slightly unfair as both drugs received approval in…

The industrial concept “continuous improvement” is helping cell therapy developers and their CDMOs make production processes more efficient. Continuous improvement emerged in the mid-1980s from the Japanese idea of Kaizen – “good change” – which is the practice of reassessing and tweaking processes on a continual basis in real time. The approach has been used in various industries to optimize complex processes with maintenance monitoring in the automotive industry being one of the most widely cited examples. Cell therapy firms…

CMC deliverables must be addressed to continue CGT momentum, but overcoming talent gaps will give firms the competitive edge, says former Spark Therapeutics CTO Cynthia Pussinen. With 10 approvals in the US and Europe last year, there is little doubt the cell and gene therapy (CGT) sector is blossoming. Consultant Cynthia Pussinen described the sector as having “lifted off and in flight” at Phacilitate’s Advanced Therapies Week earlier this month, with much progress including “truly rewriting how patients are treated…

Catalent has designed a case management service, which aims to tackle challenges associated with the safety and timeline of cell and gene therapy programs. Contract development manufacturing organization (CDMO) Catalent says the complex nature associated with delivering doses of cell and gene therapies (CGTs) means the products need to be managed correctly and efficiently to reduce the risk of production schedule disruption and administration of the therapy to the individual. The launch of the company’s case management service looks to…