New GMP and licensing laws will reshape biopharma contracting in China. But exactly what the sector will look like will depend on how they are implemented and enforced by the country’s regulator, says an expert. The Chinese National People’s Congress passed final amendments to the country’s Drug Administration Law (DAL) on August 26. The law introduces a suite of measures, including a marketing authorisation holder (MAH) system similar to those in place in the US and EU. It also reforms…
Korean CDMO Samsung BioLogics will open labs in either the Boston or San Francisco area early 2020 on the back of demand for its development services. In 2017, Samsung BioLogics added the ‘D’ to its contract development and manufacturing organization (CDMO) credentials by announcing plans to offer customers cell line and process development (PD) services on top of its well-established clinical and commercial production services. In the 18 months since launching these services, the South Korean firm has undertaken 33…
Industry has convened in Boston this week to celebrate the success of biotech and discuss the bioprocesses of the future. Bioprocess Insider brings together the best of social media as Bioprocess International, Biopharm America and the Cell & Gene Therapy congress combine for #BiotechWeekBoston.
Berkeley Lights has opened an office in Shanghai to expand the reach of its automated biological workflow platform for cell line development and antibody discovery. The office, located in Pudong, Shanghai, will provide Berkeley Lights regional marketing and pre-sales service in China and the Asia Pacific (APAC) region. The decision to open an office in the region reflects the importance of the Chinese market for the bioprocessing space, said Yue Geng, head of Asia Pacific at Berkeley Lights. “China represents…
Novartis division Sandoz has teamed with Polpharma for the commercialization rights to a Phase III biosimilar of Biogen’s multiple sclerosis monoclonal antibody Tysabri (natalizumab). The deal sees Sandoz enter into an agreement with Polpharma Biologics to commercialize and distribute worldwide the Polish biopharma firm’s natalizumab program, currently in Phase III trials. The molecule is being developed as a biosimilar of the relapsing-remitting multiple sclerosis (RRMS) monoclonal antibody Tysabri, which pulled in $1.86 billion (€1.7 billion) for Biogen in 2018. “Polpharma…
Supply of drug substance from Lonza’s stainless-steel facility in Singapore will complement production of Remsima (infliximab) within its own network, Celltrion says. Remsima is Celltrion’s biosimilar of J&J’s autoimmune best-seller Remicade (infliximab), approved by the EMA in 2013 and by the US FDA in 2016. It became the first biosimilar monoclonal antibody to be launched in Europe in 2015 and according to the Korean drugmaker it captured over 50% of the EU infliximab market by the third quarter 2018. While…
Smallpox vaccine developer Bavarian Nordic says it will expand its infectious disease and cancer pipeline and grow its manufacturing network, possibly through M&A. Danish vaccine maker Bavarian Nordic laid out its growth vision during it second quarter 2019 financial call, and said it hopes to be a leading and profitable biotech company by 2023. To do this, the firm will look to its smallpox vaccine business as a starting point. Bavarian Nordic has a long-term contract for the manufacturing and…
The Health and Human Services (HHS) funding will support continued development of V920, a live viral vectored vaccine designed to protect against Zaire Ebola virus, says Merck. Merck & Co. began developing a vaccine to protect against the Ebola virus following the 2014-2016 Ebola outbreak in West Africa. In 2017, the firm received a definitive contract funded by the Office of the Assistant Secretary for Preparedness and Response of the HHS, originally worth $126 million (€114 million), to aid development…
Zealand Pharma has taken its first steps to build US commercial operations with an aim to launch four peptides over the next five years. According to Zealand Pharma CEO Emmanuel Dulac, the Danish biotech has “one of the most predictive and promising platforms†in the therapeutic peptide space, and 20 years of discovery and R&D are rapidly approaching fruition. “We have proven that we can take multiple programs through the clinics and execute on them according to industry benchmarks. To…
With potentially three acquisitions within nine months, Agilent Technologies has rapidly grown its presence in the cell analysis space and says it aspires to grow further. Technology and services firm Agilent entered the bioanalysis space in 2015 when it acquired manufacturer of instruments and assay kits Seahorse Bioscience. Over the past nine months, Agilent has upped its position in the sector through the purchase of ACEA Biosciences, swiftly followed by the acquisition of Luxcel Biosciences , and just last month…