Newsletter | September 21, 2022

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

Featured Editorial
Industry Insights
Is Your API Ready For Scale-Up? What To Demand From Your CDMO

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.

A Faster And More Economical Path To Investigational New Drug Applications

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.

Five Ways To Get To IND/IMPD Faster

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.

Seizing Opportunity: Disruptive Forces In Advanced Cell Culture Tech

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.

Using Osmolality Measurement For Drug Formulation Development

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

Liposome Testing: Accurate Measurement Of The Size And Charge

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

Challenges Of Moving A Bioconjugate Candidate From Clinic To Market

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

Live Biotherapeutic Manufacturing Helps Make Research A Reality

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).

Full IND Program: Exceeding Requirements For Submission

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

Trends In Raw Materials Characterization In Bioprocessing

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

De-Risk Development And Manufacture Of Bispecific Antibodies With Lonza

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

Cell And Gene Market Outlook

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.

QP Release: Clinical, Commercial Expectations And Responsibilities

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

Data Utilization For Advanced Analytics And Near Real-Time Monitoring

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.

Raw Material Variability: The Need For Deeper Process Understanding

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.

FDA Guidance: Inspection Of Injectable Products For Visible Particulate

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.

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