Manufacturing

The House Energy and Commerce Committee approved a legislative amendment that would give 12-years data exclusivity to innovator biologics. The amendment was introduced by Reps. Anna Eshoo (D-CA) and Jay Inslee (D-DC).

Single-use technologies can be configured and installed fairly quickly, but are they ready to handle the urgency and scale of a pandemic?

Enabling site-wide process efficiency.

The Senate?s Health, Education, Labor, and Pensions Committee yesterday passed The Affordable Health Choices Act, the committee?s healthcare reform legislation that gives 12 years of data exclusivity to innovator biologics. The committee had adopted the 12-year data protection amendment to the healthcare legislation on Monday.

In advance of the Senate Health, Education, Labor, and Pensions Committee?s meeting to be held on Friday to consider amendments to the healthcare reform bill, including several amendments related to biosimilars, Biotechnology Industry Organization?s (BIO) President and CEO Jim Greenwood reaffirmed BIO?s support for a 12-year data exclusivity period for biologics.

Method for integration of transgenes.

The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.

By following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing

A new report by FTC, entitled ?Follow-on Biologic Drug Competition,? examines whether the price of biologics is likely to be reduced by competition from FOBs.

By considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.

Microbial systems such as E. Coli and yeasts are most effective for producing antibody fragments.

How to maintain product stability and prevent particulates.

What end users think about single-use systems.

Members of the pharmaceutical and biotech industries have formed a new industry coalition, called "Rx-360," with the goal of improving supply chain safety.

This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm.

Effective tech transfer can save time and effort in later manufacturing processes.

Biodefense start-up companies have an abundance of options when seeking funding.

Can increase in ionic strength result in higher viscosity?

Cost modeling provides valuable insights to support strategic decision-making when implementing disposable technologies.

The future of therapeutic MAbs lies in the development of economically feasible downstream processes.

Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.

A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.

In three non-affinity purification processes based on cation exchange capture with high binding capacity, applying a host cell protein exclusion strategy enabled robust scale up and better economics.

New techniques can greatly improve the MAb purification process.

The future of therapeutic MAbs lies in the development of economically feasible downstream processes.

A close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland.

With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the US Pharmacopeial (USP, Rockville, MD) Convention announced on February 4, new standards for two widely used drug products that have been involved in episodes of adulteration resulting in patient deaths.

The US Food and Drug Administration has launched a voluntary pilot program that will help promote the safety of drugs and active drug ingredients produced outside the United States.

How to choose a disposable mixing system that fits your particular needs.