Biomanufacturing?While the FDA and EMA have for the first time okayed the switch from batch to continuous manufacture of a pill – Janssen Cilag’s HIV protease inhibitor darunavir (Prezista) – the
industry is still waiting for such a signal in the biologics field. The FDA wants to boost adoption, and biopharma majors, such as Novartis, Amgen and Biogen, launched a pilot project to lay the groundwork for the next generation of production: continous USP and DSP, and alternatives to CHO cells.
Advanced formulations for biopharmaceuticals
BackgroundIn the past, the role of customised and tailored formulations have been largely underestimated in the field of biopharmaceutical product development. An advanced formulation strategy can strongly improve the product, leading to significant customer benefits. The growing and increasingly competitive biopharmaceutical market requires individual solutions, particularly for better product stability and prolonged shelf life.
EuropaBio names top EU biotech SMEs
Latest NewsThree innovative biotech companies have baged the prestigious EuropaBio SME Awards for their innovative business models.
Tumour-associated bacteria co-migrate to metastatic sites
Latest NewsThe same bacteria present in primary tumours of patients with colorectal cancer are also present in liver metastases, according to a new study. What’s more, presence of the bacteria was found to correlate with tumour growth.
AMR partnership gathers speed
BackgroundGARDP:?Six European states, together with the British Wellcome Trust and South Africa, have pledged €56.5m to help develop new antibiotics that break resistance. The ambitious goal of the Global Antibiotic Research and Development Partnership (GARDP) is to develop and deliver up to four new treatments that enter clinical development within the next six years.
Philips leads €6.3m EU liquid biopsy consortium
Latest NewsThe EU is investing another €6.3m into the blood diagnosis of primary breast cancer and rectal cancer. In the 4-year LIMA project, Royal Philips will lead a SME consortium that combines liquid biospy of circulating tumour cells (CTCs) with Magnetic Resonance Imaging (MRI).
Heidelberg Pharma AG raises €34.4m
Latest NewsAntibody-drug-conjugate (ADC) specialist Heidelberg Pharma AG has raised €34.4m through the issuance of 7,484,190 new shares at €2.60 and 14,968,380 convertible bonds with a nominal value of €1 each. Baader Bank AG acted as global coordinator and sole bookrunner.
Amsterdam applauded as new EMA headquarters
Latest NewsAmsterdam has beaten Milan and Copenhagen in the race to become the European Medicines Agency’s new home. Pharma and biotech stakeholders applauded the vote as Amsterdam achieved the hightest rate of acceptance of the EMA staff for relocatation, according to a survey.
Roche chemo-immunotherapy combo meet NSCLC Phase III endpoint
Latest NewsA Phase III study (IMpower150) sponsored by Roche has shown that a combo of the company’s PD-L1 blocker atezolizumab (Tecentriq) and VEGF blocking antibody bevacizumab (Avastin) plus paclitaxel + carboplatin vs Avastim plus chemotherapy significantly reduced the risk of disease progression or death in patients with advanced lung cancer.
Preparing for the next generation of biologics
BackgroundBiomanufacturing?While the FDA and EMA have for the first time okayed the switch from batch to continuous manufacture of a pill – Janssen Cilag’s HIV protease inhibitor darunavir (Prezista) – the
industry is still waiting for such a signal in the biologics field. The FDA wants to boost adoption, and biopharma majors, such as Novartis, Amgen and Biogen, launched a pilot project to lay the groundwork for the next generation of production: continous USP and DSP, and alternatives to CHO cells.
Expanding scale and reach
BackgroundFlexible and reliable contract manufacturing and development have become the key success factor in the development of biopharmaceuticals. Due to the long process time and high investment needed to build up production capacities, outsourcing of biologics manufacturing provides both access to advanced technologies and necessary capacity along with flexibility in timing and output.