NEWS
Recipharm adds development tools
Swedish-based CDMO Recipharm announced at CPHI that it is “ expanding its pharmaceutical development capabilities through targeted investments and the integration of cutting-edge technologies ”. This , the firm said , will bolster services at both early- and late-stage development , giving it fully integrated services that cover the whole life cycle of a molecule . These additions comprise :
• A new lab for sterile product development at the centre of excellence for NCE and generic small molecules at Bengaluru , India , which is also home to the extractables and leachables , nitrosamines and elemental impurities laboratories
• Advanced material characterisation equipment , a compression and compaction simulator , a Mini-Pactor for dry granulation , a pilot-scale capsule filler and a small-scale tablet press at both Bengaluru and the pilot-scale development centre in Zwickau , Germany Recipharm has also added preclinical , clinical and pilot-scale sterile development capabilities for both small and large molecules at two more sites in Germay . These include a GMP VarioSys line for vials and pre-filled syringes at Wasserburg and GMP LAB + equipment at Kaysersberg . It has other sites in France , India , Israel , Italy , Portugal , Spain , Sweden and the US .
Sterling to use flow on hypericin compound
CDMO Sterling Pharma Solutions is to manufacture a synthetic hypericin developed by late-stage biopharmaceutical company Soligenix for use in clinical trials for its HyBryte oncology drug . Process development is under way at Sterling ’ s Germantown , Wisconsin , facility ahead of clinical-scale GMP manufacturing , which is expected to occur in late 2024 .
The synthesis involves a specialised photocatalysed intramolecular cyclisation , for which the two firms have designed a customised flow reactor ( pictured ). This “ has the potential to not only accelerate the manufacturing process , but also improve scale-up to support the commercialisation of HyBryte ”, Sterling said .
Fabricated by German firm Peschl Ultraviolet , the “ efficient , scalable and flexible ” reactor contains six interchangeable flow cell chambers , which can be run in series or parallel , with independent temperature controls . It also includes multi-channel valves to enable in-line process analytical testing and oscillating cleaning cycles , and it will be further integrated with continuous distillation capabilities to isolate the product post-reaction .
14 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981