Author Archives: Dan Stanton

Aji Bio receives FDA approval for commercial oligo process

Ajinomoto Bio-Pharma Services’ AJIPHASE Technology has received US FDA approval for an undisclosed commercial oligonucleotide, most likely NS Pharma’s Viltepso (viltolarsen). The announcement highlights Aji’s AJIPHASE synthesis technology in its potential to scale up oligonucleotide production. “AJIPHASE is used in the development and cGMP manufacture of large-scale oligonucleotides and peptides,” a spokesperson from the company told this publication. “The AJIPHASE technology employs the use of an anchor, instead of a resin, which provides a homogeneous mixture. After the reaction occurs,…

Astrea continues acquisition path picking up purification firm Nanopareil

A transformative year for Astrea Bioseparations has culminated in a second acquisition in a month. Philip Vanek, CTO of parent company Gamma Biosciences, talks to us about the deal, the company, and the changing bioprocess landscape. In November 2019, investment firm KKR announced its intentions to buy Prometic Bioseparations from Liminal BioSciences. In January, the deal closed with renamed Astrea Bioseparations becoming the first company in KKR’s $200 million Gamma Biosciences portfolio of life sciences tools subsidiaries. Since then, the firm…

Large-scale SUS ‘ideal’ to take on COVID-19 vaccine challenge, says ABEC

ABEC will supply six 4,000 L single-use bioreactors to the Serum Institute of India and says such large-scale systems can produce billions of doses of potential COVID-19 vaccines at reasonable costs. The six Custom Single Run (CSR) bioreactors will be delivered to the Serum Institute’s site in Pune, India and will be used to manufacture Phase II COVID-19 vaccine NVX‑CoV2373. The candidate has been developed by Novavax, which last month inked a deal with the Indian vaccine maker to produce…

Guangzhou campus opens doors for bioprocess training

With support from Ireland’s NIBRT and bioprocess vendor Cytiva, the Guangzhou Bioprocess Academy has begun training the next generation of biopharma talent in China. In December 2019, this publication reported that a combined $10 million investment from bioprocess vendor Cytiva (then known as GE Healthcare Life Sciences) and Guangzhou Development District government was being used to establish a biomanufacturing training center in the Guangdong province in China. Ten months on and the center, known as the Guangzhou Bioprocess Academy, has…

Novavax and J&J ink COVID-19 vaccine fill/finish deals

To support their COVID-19 vaccine candidates, Novavax has secured space at Endo’s facility and Johnson & Johnson has struck a deal with Grand River Aseptic Manufacturing (GRAM). As Novavax progresses its COVID-19 vaccine candidate through the clinic, the firm has inked numerous deals with contract development and manufacturing organizations (CDMOs) to ensure it will be ready for large-scale production. The latest focuses on the fill and finish of the Phase II candidate, NVX-CoV2373, with a deal in place with Par…

Repligen $100m+ CAPEX plan latest example of robust bioprocess sector

Repligen will spend roughly $100 million over the next five years across all its franchises to feed the continued demand for biomanufacturing services and tools. During a recent meeting with Jefferies analyst Brandon Couillard, Repligen CEO Tony Hunt and CFO Jon Sondgres spoke about the benefits of recent expansions in its bioprocess network and said it will be spending upwards of $100 million over the next five years to support its long-term capacity needs. “We shared that we are spending…

Catalent adds early-stage plant to its blooming(ton) fill/finish business

CDMO Catalent says it is looking to serve fill and finish demand for early-phase customers in its $14 million acquisition of a second facility in Bloomington, Indiana. Three years after AB BioTechnologies broke ground on a 23,000 square-foot facility, fellow contract development and manufacturing organization (CDMO) Catalent has acquired it for $14 million – $3.5 million more than the 2017 investment. The facility adds clinical and small-scale commercial manufacturing for injectable drugs to Catalent’s growing fill and finish network and…

Combined Therapeutics wins $250,000 MilliporeSigma Advance Biotech Grant

MilliporeSigma has awarded MIT spin-out Combined Therapeutics a cheque for $250,000 as the winner of its 2020 Advance Biotech Grant. Combined Therapeutics (CTx) is an early stage startup developing next generation virotherapies targeted with nucleic acids. The pre-clinical biotech aims to develop therapies to treat liver cancer using its targeted oncolytic platform. The firm – founded by MIT professors Robert Langer and Dan Anderson, along with entrepreneur Romain Micol – was the prestigious winner Thursday of the MilliporeSigma Advance Biotech…

From flu jabs, to mAbs, to COVID collabs: BioNTech nabs Novartis plant and labs

BioNTech is buying Novartis’ facility in Marburg, Germany to support the manufacture of its mRNA vaccine candidate against COVID-19. Financial details of the acquisition have not been divulged, but the GMP facility in Marburg (about 50 miles north of Frankfurt) will be used to increase manufacturing capacity for BNT162b2, a Phase III messenger RNA (mRNA) vaccine in development with Pfizer against COVID-19. The Novartis facility houses equipment to produce recombinant proteins, and cell and gene therapies – as well as…

Moderna says ‘simple’ mRNA process allowed speedy COVID vaccine scale-up

The cell-free and enzymatic nature of its mRNA technology has allowed Moderna to quickly build a relatively small network capable of supporting commercial manufacture of its COVID-19 vaccine. On Monday, President Trump named Pfizer and J&J as leading the way in bringing a coronavirus vaccine to market. But also speaking Monday, Tal Zaks, chief medical officer at Moderna Therapeutics, believes it will be his firm that will be the first to bring both a vaccine to market and “to deliver…