SQA 2024 -- When it is time to write up an audit observation, it can be difficult to find the right words. There are dos and don'ts to writing audit findings. It is important to stay objective, state the facts and connect the finding to a regulation, standard or SOP. Also important is to know what to avoid when writing observations.

AACR 2024 -- Chimeric Antigen Receptor T (CAR-T) cell therapy has emerged as a promising approach for treating hematological malignancies, particularly B-cell acute lymphoblastic leukemia (B-ALL).

AACR 2024 -- Monoclonal antibodies (mAbs) that target tumor antigen have transformed cancer immunotherapy. Antibody-dependent cellular cytotoxicity (ADCC) is an indispensable therapeutic mechanism for mAbs, including antibody-drug conjugates, because they trigger immune-mediated antitumor activity in vivo.

AACR 2024 -- Immunotherapy aims to bolster the immune response within the tumor microenvironment (TME). However, checkpoint inhibitors utilized in the treatment of colon carcinoma have demonstrated efficacy only in certain patients.

AACR 2024 -- Traditional cancer cell lines used as surrogate models in vitro and in vivo have made significant contributions to cancer research and drug discovery.

AACR 2024 -- The failure of murine tumor models to adequately simulate the native biological milieu and tissue architecture of human malignancies, has fomented much discourse surrounding the exigencies of bench to bedside translation.

AACR 2024 -- The tumor microenvironment consists of various components such as cancer-associated fibroblasts, immune cells, blood vessels and extracellular matrix elements, all of which have the potential to interact with cancer cells.

Antibody-drug conjugates (ADCs) are formed by antibodies targeting a specific antigen or antibody fragment covalently attached to payloads (such as small molecule cytotoxic drugs) via a linker.

A global biopharmaceutical client developing a pipeline of complex antibody-drug conjugates (ADCs) needed a reliable global lab partner.

CASSS Bioassays 2024 -- ICH Q14 is a new guideline on analytical procedure development that will come into effect on 14 June 2024, and compliments a revision update (R2) of ICH Q2 Validation of Analytical Procedures - Scientific Guideline.