Issue | Pharma's Almanac

Current Issue: Q2 2017

Innovative & Expert Partners

Also In This Issue

Optimizing API Production as a True Manufacturing Partner

The required attributes of a good API — namely quality, safety and effectiveness — stem from good manufacturing processes. With an ever-expanding global patient population and the increased requirement for outsourcing, carefully selecting the right facilities and, ultimately, the right contract development and manufacturing organization (CDMO), has never been more important. With an established track […]

Biologics

Biologics: Driving Force in Pharma

These are exciting times in biologics. While the pharmaceutical market is still dominated in terms of numbers and total revenues by small molecules, 2014-2016 saw record levels of 11, 12 and eight Biologics License Approvals (BLAs), respectively, being issued, after over 20 years of the total never topping six. Meanwhile, new molecular entity (NME) approvals […]

Process Analytical Technology

Making Real-Time Process Analytical Technology In Biomanufacturing A Reality

Automated, aseptic sampling and analysis is a prerequisite for making real-time Process Analytical Technology (PAT) in biomanufacturing a commercial reality. Developed in collaboration with several leading pharmaceutical companies over an extensive development program, the Modular Automated Sampling Technology (MAST) platform from Capsugel/Bend Research allows direct transfer of aseptically collected bioreactor samples to analytical devices, providing […]

Drug Discovery

Disease-In-A-Dish: Leveraging in vitro Human Models to Advance Drug Discovery

Treatment of diseases, especially rare diseases, is very complex due to specific changes in the genetic makeup of the individual patient. As such, a more personalized approach to the generation of therapeutics is gaining greater traction not only with medical personnel, but also with the patient. The term “personalized medicine” relates to the dedication of […]

Quality by Design

Speeding Development and Reducing Costs with Analytical Quality by Design

Applying Quality by Design (QbD) principles to analytical method development leads to many benefits, such as a more efficient method development process, more robust and reliable analytical methods, and compliance with increasing regulatory requirements, including those pertaining to method lifecycle management. Well-Known Concept Quality by Design (QbD) is defined in ICH Q81 and ICH Q112 […]

Regulatory

Implications of Serialization for the U.S. Pharma Industry

New requirements under the U.S. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. Some of these requirements began in 2014; additional requirements will be phased in until 2023. The next deadline — November 2017 — applies to manufacturers. Compliance is challenging, but noncompliance […]

Regulation

Serialization: The First Steps In Sales Unit Traceability and Data Management

Increasing numbers of countries around the world are requiring some level of unit traceability in the pharmaceutical industry. While initially driven by regulations, the impacts of serialization will be far-reaching. Early adopters that implement a strategy that goes beyond compliance to leverage the vast quantities of newly generated data will be well positioned for success […]

CDMO

Supporting the Tech Transfer Continuum for Cell & Gene Therapies

As growing numbers of biopharmaceutical companies experience clinical success with new cell and gene therapies, they are satisfying their development and manufacturing needs in collaboration with contract service providers. Those organizations that can support the continuum of tech transfer projects from preclinical to commercial manufacturing will be best positioned to meet the expanding needs of […]

Past Issues

View all Past Issues

The Growing Role of Innovative Technologies

View Issue »

Issue #1 | Volume #1 | Q4 2015

The Executive Issue

View Issue »

Issue #1 | Volume #4 | Q1 2018

Market Landscape

View Issue »

Issue #1 | Volume #3 | Q1 2017

Future Pharma Partner Models

View Issue »

Issue #3 | Volume #3 | Q3 2017