Ramarketing news round-up
In this week’s news, drugs made 24/7 win approval faster, US FDA clarifies supply chain rules with CDMOs in mind, and more.
Continuous manufacturing speeds approval says FDA study
Drug companies that used continuous manufacturing (CM) technology market waited less time before approval after submission compared to batch manufacturing products, according to a new FDA audit.
The study – published in the International Journal of Pharmaceuticals – examined approval timelines and found drug companies that used 24/7 production tended to gain approval faster.
According to the authors “There were no substantial regulatory barriers identified for CM applications related to manufacturing process changes or pre-approval inspections”.
CM applicants had shorter times to approval compared to similar batch applications – 3 to 8 months on average – and commercialization was also faster – 4 to 12 months on average according to the authors.
The authors discussed their findings in an FDA podcast.
US FDA clarifies supply chain rules with two new guidance documents
Drug firms and CDMOs have a clearer idea of the US FDA’s supply chain management expectations thanks to two guidance documents published this week.
The guidelines – which cover standards and the involvement of trading partners respectively – “are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on November 27, 2023” according to the agency.
Also in the news
Some developments of note in the contracting sector:
Boehringer Ingelheim, Evotec, and bioMérieux have formed a joint venture to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance (AMR).
KBI Biopharma SA (KBI) and Selexis SA held a joint ribbon-cutting ceremony at their new facility in Geneva, Switzerland. The firms cited increased demand for biomanufacturing and cell line development.
TCG Lifesciences has inaugurated a new R&D facility in Pune, India as part of a major manufacturing capacity expansion.
Fujifilm is investing $1.6 Billion to enhance and expand the cell culture manufacturing services at its contract manufacturing unit, Fujifilm Diosynth Biotechnologies. This investment will enhance the CDMO’s sites in Hillerød, Denmark, and Texas in the US.
Bayer has opened a new R&D center at its campus in Kendall Square in Boston-Cambridge, Massachusetts.
Wuxi STA has opened another high-potency active pharmaceutical ingredient (HPAPI) production facility at its campus in Changzhou site in Jiangsu, China,
Batavia Biosciences will extend its CDMO services portfolio to include commercial manufacturing services. The company has finalized the design plans of its new 12.000 square meter building to be realized at the Bioscience Park in Leiden, The Netherlands.
More in the news:
Sharp expands clinical services operations at its Heerenveen facility – adding labeling and secondary packaging services to support open and randomized clinical trials.
Pfizer gets access to Touchlight’s ‘doggybone DNA’ tech to make vaccines, gene therapies, and more.
The BBC published an article on a breast cancer drug trial: Woman given months to live gets the all-clear.
According to drug target review human urine-derived stem cells have robust regenerative potential. A new study provides the possibility to evaluate the capacity of telomerase-positive human urine-derived stem cells to become a wide variety of other cell types.