Drug delivery is advancing into a digital future. Information technology is changing aspects of every operation in the biopharmaceutical industry. Meanwhile, machine learning and cloud computing are not only finding their way into drug development, manufacturing, and distribution, but also into drug-product delivery devices themselves. As a result, many biopharmaceutical companies are seeking medical device expertise through strategic alliances and contract services. New delivery devices can help big companies extend patent protection on established marketed products, for example, and provide…
Tuesday, November 24, 2020 Daily Archives
eBook: Drug Delivery —
Your Guide to Efficiently Develop Antibody-Based Therapeutics
This eBook presents various techniques used to measure the stability of antibody-based biotherapeutics. The authors address the ins-and-outs of monoclonal antibody (MAb) formulation, cover Investigational New Drug (IND) and New Drug Application (NDA) filing timelines, and explain how storage conditions affect MAb stability. Monoclonal antibodies have been used in therapeutics for more than 30 years. Efforts to further develop and optimize better MAb-based biotherapeutics are increasing as they have become increasingly popular for the treatment and prevention of many diseases…
Roche licenses cell line-based AAV vector tech from CEVEC
Roche will access an adeno-associated virus (AAV) vector manufacturing platform for its gene therapy portfolio in a deal CEVEC says validates its ELEVECTA technology. The deal, financials of which have not been disclosed, will see Swiss pharma giant Roche use CEVEC’s ELEVECTA Technology for AAV vector manufacturing across its gene therapy portfolio, including products being developed by its acquisition Spark therapeutics. ELEVECTA, launched in April this year, is a platform that allows for the large-scale production of AAV vectors from…
Pharming doubling downstream capacity for commercial HAE therapy
Pharming Group will build a facility at its site in Oss, the Netherlands to increase downstream manufacturing capacity for Ruconest, a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with hereditary angioedema (HAE). Dutch pharma firm Pharming is building a new facility to expand downstream processing capacity at its site in Pivot Park, Oss. Once operational, the facility will carry out the purification, filtration and concentration of the starting material for lead product Ruconest…
Rubius touts shelf life of cancer therapy, citing manufacturing process
Rubius Therapeutics has shared details of the manufacturing process for RTX-321, a candidate cell therapy for HPV positive cancers that it says is a “truly†off the shelf product. The US biotech made the claim in an IND filed with the FDA earlier this month. It said the “filing for RTX-321 included, for the first time, frozen drug substance as part of the manufacturing process, resulting in a truly off-the-shelf cellular therapy with a potential shelf life of up to…