CMOs & CROs and Pharma Packaging
COVID-19 has significantly impacted the business of CDMOs and CROs: Manufacture of potentially protective vaccines and antiviral antibody sera for treatment and passive immunisation as well as stratification of hundreds of thousands of healthy volunteers are challenging the industry, while development and production of biologics for chronic indication must go on. From preclinical development to market approval, the trend to outsource clinical development, biomanufacturing, and packaging remains unbroken: from hits to leads and POC and from DoE, QbD over scaleable process development to customised and even continuous USP, DSP, polishing, sterile filling including serialisation. However, as novel formats for biologics and biosimilars emerge, diversi cation through special know-how is key to market success. New formulations, delivery forms, trial formats and patient enrolment strategies also challenge the growing industry.
Focus: CROs & CMOs and Pharma Packaging
- Pandemic impact on contract research and biomanufacturing
- Interview: High need for antiviral mAbs
- BREXIT: EU clinical trials post-2020