CencoraBest PracticeMitigating regulatory risk with holistic CMC strategiesAs advanced therapeutic medicinal products (ATMPs) and other next-generation biologics move toward approval, Chemistry, Manufacturing and Controls (CMC) continues to be the most frequent source of regulatory … more ➔
Boehmert & BoehmertIntellectual PropertyIs the Unified Patent Court affordable for small biotechs?The Unified Patent Court and the unitary patent were established to make patent litigation in Europe easier, faster and more affordable. It has been particularly emphasized that the new system was designed … more ➔
Alexander Sievert Photography Cell TherapyPL BioScience: Pioneering the Future of Cell CultureWith the promise of transformative treatments, cell therapies are rising across oncology, regenerative medicine, and stem cell applications. PL BioScience supports this evolution with Human Platelet … more ➔
Bayer Co.LabIncubatorBerlin: Why Start-ups Choose Bayer Co.LabOne year after the inauguration of Bayer Co.Lab — the open workspace for start-ups in Berlin — it is time to take stock. European Biotechnology News Magazine spoke with tenants and with Dr Ruth … more ➔
Yumab GmbHADCAntibodies: Cornerstone of ADC precision and efficacyAntibody-drug conjugates (ADCs) hinge on the antibody, not merely the payload or linker. Antibody precision defines efficacy, safety and therapeutic window. Emerging antibody formats – bispecifics, … more ➔
Concept Heidelberg GmbHBioanalyticsFrom method validation to the life-cycleEarlier guidelines such as ICH Q2(R1) and USP , , and viewed analytical method validation as a discrete activity focused primarily on chromatographic procedures. With ICH Q14, ICH Q2(R2), and USP , … more ➔
TenthpinTransformationCDMO: An SAP S/4HANA transformation in In Life Sciences, SAP transformations for midsize CDMOs are nothing short of complex. But integrating a newly acquired site into an existing SAP landscape is a different matter entirely. At Tenthpin, … more ➔
X-act Cologne Clinical Research GmbHClinical researchData-driven excellence: the cornerstone of clinical researchEssential areas such as study planning, interpretation, regulatory guidance, and key study design decisions remain human responsibilities, although AI increasingly supports routine tasks. X-act gets … more ➔
Die Hoffotografen GmbHCell therapySolid tumours meet their matchSolid tumours pose major obstacles for cell therapies, but German-American biotech T-knife is tackling them head-on. CEO Tom Soloway and CTO Elisa Kieback share how their “supercharged” TCR-Ts are … more ➔
Boehmert & BoehmertRegulationUS-policy-made challenges for the bio-pharma sectorNew developments under the current U.S. administration may be a challenge for the pharma/biotech industry: the Inflation Reduction Act, Orange Book Challenges, Most Favored Nation Policy, and the new … more ➔