09.21.22 -- 5-Year Biotech Lookback & What It Bodes For Tomorrow

A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.

Read how new membrane-based protein A affinity chromatography technology can greatly shorten the time it takes to get to IND while also making the process less expensive and more adaptable.

How do you get to IND/IMPD without sacrificing quality and future commercialization goals? Experts share considerations for accelerating and optimizing your early development process.

The market for biological drugs continues to grow at an impressive pace. Explore three key trends that will underpin the sustainable growth of biopharma beyond COVID-19.

See how osmotic pressure is necessary in ensuring patient safety, with the sensitivity of an osmometer reading ensuring a robust measurement of solute concentration.

The size and surface charge of liposomes—spherical engineered particles made of phospholipids—are important characteristics that require measurement and monitoring in biopharmaceutical applications. 

Drug developers must successfully navigate the path to market, under the growing pressure of regulation and competition, while carefully managing technical and financial risk.

The species contained in the human gut microbiota encode more than 3.3 million distinct genes, creating almost endless research possibilities for live biotherapeutic products (LBPs).

Follow a compound through a full cycle of IND development, from modifications to the synthetic route to formulation development and API manufacturing.

Find out more about the current trends shaping the future of raw materials characterization in bioprocessing, and how you can take advantage of them.

Explore how to meet the unique challenges of assembling and expressing bispecific antibodies to advance them for first-in-human trials. 

Read on for a closer look at the findings in ISR’s Cell & Gene Therapies Market Outlook report, which offers some insight into the growing cell and gene therapy field for innovators and manufactures alike.

Supplying into European countries requires planning, regulatory experience, GxP-compliant facilities, robust processes, and, critically, a qualified person (QP) named on the license.

Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.

Principles and methods for biopharma development and manufacturing are well established, but increased molecular diversity and a drive for higher productivity bring new challenges to process developers.

A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.