Drug Target Review

OCTOBER 3, 2024

The creation of sophisticated human antibody libraries covering a vast immune repertoire through de novo synthesis, such as HuCAL (human combinatorial antibody library), 7 combined with phage display technology and optimised for in vitro expression, have revolutionised the development of recombinant monoclonal anti-idiotypic antibodies.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Premier Consulting Blog

OCTOBER 26, 2022

Development of the manufacturing process description The development of the MPD is an iterative process. The MPD is best created and controlled by a sponsor, rather than by a contract development and manufacturing organization (CDMO) assigned to perform the process and assay development.

Production 40

Production Assay Development Clinical Supply Clinical Development 40

Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials? Healthy cells may also serve as a valuable control in experiments.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40