Poor aseptic practices can rapidly ruin market supply of products outsourced for production. This year, Celltrion came under fire from FDA inspectors. At the end of January, the producer received a warning letter affecting the production of Inflectra biosimilar infliximab-dyyb (CT- P13) co-marketed with Pfizer. In mid-February, the FDA added a warning concerning rituximab and trastuzumab biosimilars produced for Teva, as well as for its fast-track migraine mAb fremanezumab.
Rutger Oudejans, Brand Director at bioLIVE, postulates that the bio supply chain could learn some lessons from the small molecules sector. The bio industry continues to expand at rates above the traditional NCE (New Chemical Entity) sector, yet for the supply chain there are vital synergies that could help further accelerate developments.
While bio-based polymers have been a hot topic for some years now, its grown increasingly clear that where plastics end up is at least as important as how theyre made. Current recycling technologies are limited, bringing either low-quality recyclates or high processing costs. But enzymes now offer a glimmer of hope. Working with the common plastic PET, a French firm is trying to prove biotech approaches can close the loop in the materials life cycle. They hope theyll soon be able to recycle the plastic endlessly and affordably.
At the 11th Berlin Conference, Novo Holdings outlined details of a new €135m investment fund launched to push the development of new drug classes urgently needed to fight antimicrobial resistance. European Biotechnology editors were the first to talk with Aleks Engel, Partner at Novo Holdings, and George Griffin, Chair of the Repair Impact Funds Scientific Advisory Board, about the construction and the goal of the fund.
The adage you are what you eat is more than folk wisdom. Evidence that the food you ingest has a major impact on your health grows by the day. Its now clear the bacteria that colonise the skin and gut from birth on are key sensors for environmental triggers in chronic diseases of civilisation. Ever since research showed that restoring microbiome balance cures 90% of all Clostridium difficile infections, food manufacturers, pharma companies and independent teams have been tracking it in other indications – including multiple sclerosis.
Personalised medicines, intelligent packaging and FDA deadlines seen as major trends for pharma packaging in 2018.
Since the earliest attempts at genetic engineering, scientists have sought to influence cell behaviour and development through the introduction of foreign genetic material. Synthetic biologists are now taking the idea to a whole new plane with app-like DNA-based software programs that turn cells into diagnostic sensors, therapeutic entities or tissue generators.
For decades, researchers have searched without success for a strategy to prevent malaria. Now, two teams of researchers present a solution that circumvents the problem of surface antigen hypervariability of Plasmodium. Their drug candidate blocks the pathogens release from blood cells, resulting in prevention of the life-threatening hot stages.
Spanish biotech sector:?European investors more and more often take a look at Southern European biotech companies. Spain, in particular, is now harvesting the fruits of long-term public support started a decade ago, which stimulated the establishment of a dynamic ecosystem. Today, foreign investments are at an all-time high and start-ups find a well-prepared basis for growth.
A complaint against the EMAs handling of a referral procedure related to potential side effects of Sanofi/MSDs HPV vaccine Gardasil and GSKs HPV jab Cervarix, filed by the Nordic Cochrane Centre and physicians, has been rejected by the European Ombudsman.