Also in This Issue

CDMO

Biopharmaceutical Manufacturing Goes Mainstream

With biologics, the maxim is “process is the product,” and suppliers are meeting the technologies demanded by developers with an equal amount of innovation.

Biologics

The Road to Biologics’ Continued Success

In a short period of time, biopharmaceuticals have had a tremendous impact on both the pharma industry and the lives of countless patients.

Biologics

Biologics: Driving Force in Pharma

Biologics actually accounted for six of the top eight drugs by revenues in 2016.

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.

Drug Discovery

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

A personalized approach to the generation of therapeutics is gaining greater traction not only with medical personnel, but also with the patient.

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.

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.

Regulation

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

While initially driven by regulations, the impacts of serialization will be far-reaching.

CDMO

Supporting the Tech Transfer Continuum for Cell & Gene Therapies

Organizations that can support the continuum of tech transfer projects will be best positioned to meet the expanding needs of the marketplace.

Biologics

Propagating a Full Spectrum of Services for ADC Development and Manufacture

The development and manufacture of antibody-drug conjugates (ADCs) requires expertise in both biological drug substance and API technologies.

Regulatory

Moving Quality to the Forefront Brings Measurable Results

Quality initiatives are imperative in the pharmaceutical industry, but not all quality systems are equal.

Biologics

Making Strides: Biologics Push Forward

Biologics are no longer seen as the ‘next big thing’ in drug development; they are now a mainstay in many pipelines.

Clinical Trials Find a Device for Growth

Technology developments and a growing population are driving growth in the clinical trials market.

The Search for Alternative Delivery Methods Continues

While biologic drugs offer numerous advantages, the need to administer them parenterally is a significant limitation.

Innovation

From Blobs to Hearts: Understanding the 3D Bioprinting Revolution

Additive manufacturing (AM), commonly referred to as ‘3D printing,’ is a revolutionary technology that seems to bleed across disciplines.

API

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.

API

Small Molecule Injectable Manufacturing: Challenges and Complexities

Despite the growth of biologic drugs, medicines based on small molecules remain important in the treatment of all types of diseases.

CDMO

Building a One-Stop Shop CDMO for Biopharmaceuticals

There are few true one-stop shop organizations providing support to pharma companies developing biosimilars and branded biologics.

Drug Delivery

The People’s Choice: Premeasured Single Dosage Forms

Taking medication as intended is an issue for many patients — single unit packaging is a solution for better FDA and patient compliance.

Equipment

Design of Complex Biopharmaceutical Facilities: Considering Options and Alternatives

The movement of next-generation drug products toward commercialization is driving the need for new and different technologies and facilities.

Innovation

Designing Flexibility for Added Value

Biopharmaceutical facilities today rely on a wide range of equipment and processes that require a high level of flexibility.

Equipment

Fit Biopharmaceutical Facilities: A Predictive Maintenance Approach

It is essential that both mature and newer existing facilities manage the aging process.

Oral Solid Dosage

Nice Symposium Oral Solid Dose 2017: Bringing the Supply Chain Together to Tackle Development Challenges

The first-ever “Nice Symposium,” hosted by That’s Nice, brought together a diverse range of service and technology providers and their customers.

Biologic

Q: If You Could Have One Piece of Biologic Manufacturing Equipment Improved, What Would It Be and Why?

Improving bioreactor and cell retention setup used in perfusion processes could be a major improvement area for biologic manufacturers.

Roundtable

Q: How is Growth in the Biosimilars Market Impacting the Development of New Biologics Manufacturing Equipment Technologies?

Biosimilar market growth is heightening the pressure to improve cost and quality.

Roundtable

Q: Has Downstream Processing Technology Caught up with the Significantly Higher Titers Coming Out of the Current Upstream Process? If No, What Issues Remain?

Yes, downstream technology development is advancing to accommodate higher titers via multiple chromatography approaches.

Roundtable

Q: What is the Most Significant Recent Advancement in Downstream Bioprocessing Technology? Why is it so Important?

Recent advancements in continuous chromatography and SPTFF are all contributing to significant improvements across the complete process.

Issue Q1 2019

The Business Development Issue

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Issue #1 | Volume #5 | Q1 2019
Issue Q4 2018

The Innovation Issue

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Issue #4 | Volume #4 | Q4 2018
Issue Q3 2018

The Outsourcing Issue

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Issue #3 | Volume #4 | Q3 2018
Issue Q2 2018

The Next-Generation Issue

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Issue #2 | Volume #4 | Q2 2018