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Astellas invests $256m in Japanese and US antibody and cell therapy sites

Astellas says it is responding to the supply needs of future pipeline by constructing two multi-modality Japanese sites and relocating a regenerative medicine plant in Massachusetts. Both R&D and manufacturing are being looked at through the expansion of sites in Toyama and Tsukuba, Japan, and Massachusetts, US to progress the development and commercialization of Astellas’ portfolio. “Astellas is responding to the progress being made in the development and launch of new drugs from its existing portfolio and pipeline,” a spokesperson…

GSK to ramp-up Shingrix vaccine as demand outstrips supply

by Dan Stanton

GSK says it is pleased with the launch of its shingles vaccine Shingrix but supply going forward is limited by a lack of manufacturing capacity. In October 2017, GlaxoSmithKline received approval from the US Food and Drug Administration (FDA) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted), its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). A year on, the Big Pharma firm announced Shingrix sales of £286 million ($372 million) for its third quarter, helping to boost its…

Q3 saw $1.5bn in biotech IPOs, and no slowdown in sight

by Dan Stanton

The biotech sector saw the largest capital investment over the past quarter and life sciences’ momentum has far from peaked, says accounting firm CohnReznick. In the past financial quarter, life sciences and biotech initial public offerings (IPOs) pulled in $1.5 billion (€1.3 billion) in capital investment. According to national professional services and accounting firm CohnReznick, the sector was the number one industry for IPOs, with 20 deals taking place in the quarter, representing 30-35% of all deals. “There has been…

Biocon investing $200m into second MAb plant in India

by Dan Stanton

Construction is under way on a hybrid biomanufacturing plant at a site in Bangalore, set to support Biocon’s growing monoclonal antibody (MAb) portfolio. Indian drugmaker Biocon has a growing pipeline of biological products, including Ogivri, the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved by the US Food and Drug Administration (FDA) last December, and Fulphila, the first US biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), approved in June. Both are marketed by Mylan, but including products developed in…

Samsung Bioepis riding the biosimilar third wave

by Dan Stanton

Samsung Bioepis has beefed up its biosimilar pipeline with versions of Lucentis (ranbizumab) and Soliris (eculizumab) under development. In Europe, South Korean biopharma firm has achieved commercial success with four biosimilar products. In the US – through commercialization partner Merck & Co. – it has launched one and has two other biosimilars under review. When looking at the market and large pharma biosimilar makers such as Pfizer and Sandoz “we are up to par with the ‘big boys’ in terms…

Avid to triple process dev capacity on early-stage demand

by Dan Stanton

Since becoming a pure-play CDMO, Avid Bioservices says it is experiencing growing demand for process development services and has begun expanding capabilities at its site in California. At the turn of the year, Avid Bioservices became a pure contract development and manufacturing organization (CDMO) by selling off its internal monoclonal antibody programs to Oncologie and dropping its Peregrine Pharmaceuticals nametag. To grow the business further, Avid has begun a project to expand its process development services by adding 6,000 square feet…

Turning of the tide: High potential for oligos, says survey

by Dan Stanton

Within the tides space, oligonucleotides hold the most opportunity for commercial success and growth say respondents of a KNect365 survey. The oligonucleotide therapeutic market could be viewed as having suffered a false start. The potential of antisense oligonucleotides to silence specific genes was jumped upon in the 1980s with numerous companies investing heavily in the field and commencing hundreds of clinical trials. However, the unexpected complexity of oligonucleotide pharmacology somewhat dampened the sector. And though the US Food and Drug…

Merck & Co. pumping up to $16bn into biomanufacturing

by Dan Stanton

Merck & Co. has upped its capital expenditure plans through 2022 to increase manufacturing capacity in areas including oncology and vaccines. At the beginning of the year, tax changes in the US led to a wealth of potential investment promises by Big Pharma looking to benefit from lower corporate rates and to repatriate cash from overseas. Merck & Co. (known as MSD outside North America) was one such firm, and in its February earnings call it announced plans to invest…

Janssen closing in on ‘holy grail’ through $82m HIV vaccine plant

by Dan Stanton

Janssen has opened a single-use manufacturing facility in Leiden, the Netherlands to support the commercialization of its preventative HIV vaccine candidate. Commissioned in 2014, the multipurpose vaccine production facility is being inaugurated today (Thursday October 25) in Leiden, the Netherlands and will initially be used to manufacture the firm’s investigational mosaic HIV-1 preventive vaccine. The facility represents an investment of €72 million ($82 million). The facility came about following the 2014 Ebola outbreak in West Africa, Dirk Redlich, VP of…

Novartis growing CAR-T network amid slow Kymriah sales

by Dan Stanton

Novartis says it remains confident Kymriah will pull in $200 million in 2019 through the remediation and ramp-up of its CAR-T manufacturing network. For the third quarter 2018, Kymriah (tisagenlecleucel) netted Novartis $20 million (€17.4 million), making a total of $48 million for the first nine months of the year. The product became the first chimeric antigen receptor (CAR) T-cell to be approved in August 2017. Elizabeth Barrett, chief executive officer of oncology at Novartis, said the sales figures were…