Global Markets Archives - Page 30 of 41 - BioProcess InternationalBioProcess International

Genentech on tech transfer: ‘Small volumes are all a bit new to us’

Genentech says it is looking to disruptive technologies for a fast and agile response to capacity demands as its portfolio evolves away from large volume biologics. At BPI West in Santa Clara last week, Eric Fallon, senior director of Pharma Technical Innovation of Technology & MSAT at Genentech, spoke about the difficulties in driving performance and carrying out tech transfers within its large global manufacturing network. “Our manufacturing infrastructure is built around large, economies of scale, facilities. They can be…

Access to smart money a key life science growth driver, Dynamk

by Dan Stanton

Bioprocess executives moving to the financial sector shows a strong desire for continued investment in the life sciences space, says Daniella Kranjac from VC firm Dynamk. Reinhard Vogt joined venture capital (VC) firm Dynamk Capital as a new general partner and managing director earlier this year, following an illustrious career in bioprocessing. Bioprocess Insider recently spoke with Vogt about major investment opportunities, but in this follow-up Q&A, Daniella Kranjac, co-founder and managing partner at Dynamk, explains how his expertise strengthens…

We are in the ‘golden age for the CDMO space,’ says Thermo Fisher

by Dan Stanton

With over 75% of new molecules coming from small and emerging biotech, opportunities for third-party manufacturers have never been so large says Thermo Fisher CEO Marc Casper. Thermo Fisher jumped into the third-party biomanufacturing space in August 2017 through its acquisition of contract development and manufacturing organization (CDMO) Patheon for around $7.2 billion (€6.4 billion). The firm has also had capabilities in the CDMO since the early 2000s through its clinical trials’ service offerings. Speaking at the 2019 Barclays Global Healthcare Conference,…

Pfizer’s trastuzumab becomes US biosimilar number 18

by Dan Stanton

The US Food and Drug Administration (FDA) has approved Trazimera, Pfizer’s version of Roche cancer drug Herceptin (trastuzumab). Trazimera has been approved as a biosimilar version of Herceptin to treat human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fourth version of the Roche bestselling monoclonal antibody (MAb) to receive the regulatory thumbs up in the US. Mylan’s Ogiviri received approval in December 2017 and in the past…

Celltrion injects $51m to get under the skin of infliximab competitors

by Dan Stanton

Celltrion Pharm has pledged KRW 58.2 billion won ($51 million) to establish a production site for Remsima SC, a subcutaneous version of its Remicade biosimilar. Korean drugmaker Celltrion has achieved regulatory success for its biosimilar of J&J’s Remicade (infliximab) across several key markets and is now looking to receive approval and launch a subcutaneous version of the immunosuppressive monoclonal antibody. To prepare for launch, the firm has committed KRW 58.2 billion won ($51 million) to its site in Cheongju, South…

Fresenius awaiting success before investing further in biosimilars

by Dan Stanton

Having acquired a portfolio of biosimilar candidates in 2017, Fresenius Kabi says it needs “to earn the right to spend” further in the space through commercial sales. Fresenius Kabi entered the biosimilar space in 2017 through the €656 million ($645 million) acquisition of Merck KGaA’s pipeline and Swiss-based R&D staff. The total number of molecules in development have not been divulged, but Fresenius has said it is in the high single-digits and includes versions of AbbVie’s Humira (adalimumab), Amgen’s Neulasta…

From Sartorius to VC, Dynamk’s new MD talks life science investment

by Dan Stanton

AI, regenerative medicine enabling technologies, and clinical diagnostics are major investment opportunities, says life science executive Reinhard Vogt who has joined Dynamk Capital. Reinhard Vogt served as an executive at Sartorius AG for over 35 years. During his tenure, he was responsible for the strategic development of the firm’s Bioprocess Division that grew from around $30 Million to around $1.2 billion today, reached through a combination of strong organic growth and a strong focus on M&A and the integration of…

Charles River CRO to continue to expand biomanufacturing support biz

by Dan Stanton

Following a strong year for its manufacturing services division, Charles River Laboratories intends to invest further to benefit from the high growth in biologics. Contract Research Organization (CRO) Charles River reported full year 2018 revenues of $430 million (€381 million) within its manufacturing support division, up 11.9% on the previous year. The unit provides manufacturing services for drug developers, including cell line characterization, lot release testing and stability studies. Increasingly, the business has focused on biologics, reflecting industry’s shifting pipelines,…

Samsung Bioepis inks biosimilar deals to enter China

by Dan Stanton

Samsung Bioepis has teamed with C-Bridge Capital to bring its third-wave biosimilars to the Chinese market. C-Bridge will establish a new company, AffaMed Therapeutics, under terms of the deal, and will license multiple biosimilar candidates from Samsung Bioepis to commercialize in China. These include the third-wave biosimilar candidates SB11 and SB12 – versions of Roche/Novartis’ Lucentis (ranibizumab) and Alexion’s Soliris (eculizumab) – and SB3, a biosimilar of Roche’s Herceptin (trastuzumab). The deal comes weeks after a partnership deal with 3SBio…

VBAs and marketing campaign to aid RNAi Onpattro ramp up, says Alnylam

by BPI Staff

Around 200 patients have so far been treated with Onpattro (patisiran), the first approved RNA interference (RNAi) drug, bringing in $12.5 million for Alnylam. In August 2018, the US Food and Drug Administration (FDA) and the European Commission (EC) approved Alnylam Pharmaceuticals’ Onpattro for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The approvals heralded in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. Onpattro works by silencing a portion of RNA involved…