Also in This Issue

M&A Activity

M&A Activity in a Fragmented CDMO Market

While there has been a slowdown in M&A in the pharmaceutical industry, the contract services market remains highly fragmented and players large and small continue to enhance their competitiveness through inorganic growth.

Laboratory Testing

Creating Comprehensive Solutions through Laboratory Testing

Lack of effective management of the outbound distribution of clinical trial materials can negatively impact study outcomes.

Artificial Intelligence

Artificial Intelligence in Biopharmaceutical Manufacturing

Artificial Intelligence (AI) has significant potential to change the healthcare industry, from the way patients receive treatments to the ways in which drugs are discovered and manufactured.

Viral Vector

Ensuring Confidence in Viral Vector Manufacturing

Cell and gene therapies are rapidly advancing to late-stage clinical trials and commercialization.

Parenterals

Expanding U.S. Supply Options for Large-Volume Parenterals

With limited numbers of producers supplying large-volume parenterals (LVPs) to the US market, shortages can result when natural disasters or manufacturing problems interrupt production operations.

Supply Chain

Overcoming Challenges in the Complex Market for Clinical Trials and Clinical Logistics

Increasing complexity, evolving treatment strategies, advancing technologies, data security challenges and the growing focus on patient centricity are all impacting the way in which clinical trials are conducted.

Serialization

Facilitating Implementation and Customer Service with Offline Serialization

Even though the FDA has extended the deadline for compliance with unit serialization requirements, UPM Pharmaceuticals serialized its first commercial product in May 2017, well ahead of time.

Strategic Collaboration

Driving Change in the Pharma Industry and Biotech One Relationship at a Time

Although small and medium-sized pharma and biotech companies are driving the growth of the industry, they often don’t receive the attention and assistance that are essential to their success.

Industry

Why Business Continuity Management is Important for CDMOs

Members of the pharmaceutical industry have a responsibility to guarantee both the supply of high-quality medicines and the safety of their personnel.

Discovery

A New Landscape: M&A in the Discovery & Research Sector

The CRO market is condensing while experiencing rapid growth.

Fill/Finish

Getting to the Finish Line

The industry’s accelerating development of biopharmaceuticals has put pressure on the supply chain to improve and modernize fill/finish operations.

Sponsor

What’s Driving M&A Among Pharma Sponsors?

Companies are seeking access to new technologies, looking to expand their pipelines and therapeutic expertise and reach both new patient populations and geographies.

Capsules

Overcoming Formulation Challenges with Liquid-fill Capsules

Liquid-filled hard-shell capsules enable formulators to overcome issues with complex APIs, while also achieving improved efficacy and safety.

Pharmageddon

Uniting the Industry for the Prevention of “Pharmageddon”

Revolutionary change is occurring in the pharmaceutical industry.

Equipment

Microbial and Biological Decontamination of Equipment Brings Peace of Mind

The ramifications of an adverse biological occurrence are higher in the pharmaceutical industry than in any other.

Formulation

Investing in New Technologies for Innovative Functional Solutions

Following a reorganization and finalization of its new growth strategy, SPI is re-engaging in innovation.

Drug Delivery

Supporting Parenteral Development and Manufacturing with End-to-End Services

The manufacture of biologic drug products, particularly those that require aseptic processing, is quite complex and requires specialized expertise.

Death to Cleanrooms in Biopharmaceutical Manufacturing

Recently, advances in the design, form, function and operation of bioprocessing equipment has made it possible to close — or functionally close — biological active ingredient (API) manufacturing operations.

Injectables

Meet Chemo CMO: Preferred Partner for Injectables Manufacturing

API sterilization is a unique capability, and particularly important for products formulated as suspensions.

Biologics

Fully Supporting Customer Needs for Biologics Development and Manufacturing

Over the past seven years, Samsung BioLogics has constructed three state-of-the-art production facilities offering end-to-end integrated services to support the rapidly expanding clinical and commercial needs of customers.

API Manufacturing

Meeting the Need for Small-Volume API Manufacturing

As the pharmaceutical industry shifts its focus from blockbusters to targeted therapies, the demand for active pharmaceutical ingredient (API) manufacturing capabilities at the kilogram scale is increasing.

Fermentation

Focused on Fermentation

Microbial fermentation continues to be an important upstream bioprocess for the production of conventional and next-generation biologics

Lyophilization

Leveraging Lyophilization Development Expertise for Clinical Manufacturing

Biopharmaceutical companies are increasingly relying on contract service providers with specialized lyophilization expertise and equipment.

Q: What Role has M&A Played in your Company’s Growth?

How mergers and acquistions have made an impact.

Roundtable

Q: How do you Address Operational Excellence as an Institution?

Planning for growth and flexibility at the operational level.

Issue Q3 2019

The Networking Issue

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Issue #3 | Volume #5 | Q3 2019
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