Pharmaceutical Technology-03-02-2020

Pharmaceutical Technology

Embracing Change Management

March 02, 2020

Ask the Expert

44

3

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Double Planetary Mixer

March 02, 2020

Product Spotlight

44

3

The Double Planetary Mixer from Ross is scalable through 1000-gallon production models and is offered in a sanitary turnkey configuration that features a stainless-steel workbench for the mixer and discharge system.

Isolator Head for Microbial Air Sampling

March 02, 2020

Product Spotlight

44

3

The SAS Tri-Clover Isolator Head from Cherwell Laboratories allows for precise and flexible monitoring of isolator cabinets and filling lines in cleanroom, isolator, and other controlled areas.

Compressor-Free Plate Sealer

March 02, 2020

Product Spotlight

44

3

Thermo Fisher Scientific launched the ALPS 5000 Plate Sealer to simplify the plate sealing process and provide enhanced dependability and productivity for stand-alone and integrated robotic projects.

Double Clamshell Barrel Continuous Processor

March 02, 2020

Product Spotlight

44

3

Readco Kurimoto introduced a continuous processor with a double clamshell barrel design that provides full access to the paddle and screw assembly to enable thorough cleaning and inspection processes while allowing for easy adjustments to the configuration.

Noteworthy Historical Cases of Adverse Drug Reactions

March 02, 2020

Development

44

3

A brief overview of three notable cases of adverse drug reactions.

Study Finds Dose-Dependent Persistent Visual Side Effects with Sildenafil

March 02, 2020

Development

44

3

A study finds a potential risk of persistent visual side-effects in male patients taking the highest recommended dose of sildenafil.

The High Price of R&D

March 02, 2020

From the Editor

44

3

Despite increasing R&D budgets by bio/pharma companies, returns on this investment are reducing and the cost of bringing an asset to market is increasing.

Playing Catch Up with Big Data in Europe

March 02, 2020

Regulatory Watch

44

3

EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.

Navigating GMPs for Gene Therapies

March 02, 2020

Quality/Regulations

44

3

While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.

Industry pushes forward with cell and gene therapies

March 02, 2020

Cover Story: Cell and Gene Therapies

44

3

The last year has seen intense investment activity into raising cell and gene therapy manufacturing capacity.

Pharmaceutical Technology North America, March 2020 (PDF)

March 02, 2020

Issue PDF

44

3

Click the title above to open the Pharmaceutical Technology March 2020 issue in an interactive PDF format.