Also in This Issue

Research Database Recommendations

That's Nice recommends a list of databases that will aid CDMOs and CROs in becoming industry leaders.

Quality Culture Wins Over Compliance

Quality has evolved from focusing on the what (defining the product) to the how (improving how it is produced) over the past years.

Process Safety Evaluations Crucial to Successful CDMO Operations

The first step in establishing an effective process safety strategy is determining the company’s capabilities & limitations—with respect to process hazards.

Mergers and Acquisitions: Protecting The Core and Maximizing Value

Most research indicates that only 40% to 60% of mergers succeed — and just 30% are cross-border mergers (Association for Corporate Growth).

Investment Recovery for Pharma Equipment – Part 1

An effective capital equipment investment recovery strategy can turn idled equipment into money-making assets, and network redeployments that save money.

Establishing Specialized CDMO Capabilities for the Production of Advanced Therapies

A commitment to transparency, open communication, and a genuine respect for the needs of each client’s individual projects are essential for CDMOs to succeed.

Enabling Right-First-Time Tech Transfer with Effective Scale-Down Modeling

Biopharmaceutical CDMOs must have extensive knowledge about the impact of process conditions on product characteristics.

Dose and Form Matter: Future of Care Demands Optimal Drug Delivery

Results observed in clinical trials do not always translate into what is being experienced by consumers in the marketplace, key reason - non-adherence.

Biopharma’s Ascendant Supply Chain Reveals its Present Potential & Future Promise

According to the 2016 Nice Insight CDMO Outsourcing Survey, about two-thirds of companies are developing large-molecule products as new biological entities (NBEs).

Bioavailability: What Are Your Thoughts On Enhancing Bioavailability With Novel Technologies?

Innovators with new molecules are looking for their supply chain partners to deliver innovative technologies to make chemicals more soluble.

Antibody-Drug Conjugate: Do We Understand The Capital Investment In Our Staff?

ADCs are a huge challenge in terms of manufacturing and capital investment because a company needs to build both biologic and chemical synthesis capabilities.

A Holistic Interpretation of Commitment to Quality

Demand for injectable drug products is increasing, due to growth of the biologics market & injectable formulations offering a mechanism for increased efficacy.

Nice Insight Pharmaceutical Equipment 2016 Annual Study

The 2016 Nice Insight Pharmaceutical Equipment Survey was deployed to around 489 industry professionals worldwide.

From Qualified to Ideal: The Importance of Partnership

According to the 2016 Nice Insight CDMO Survey, nearly 70% of outsourced projects were sent to a combination of preferred providers & strategic partners.

Accelerating Drug Development and Manufacturing with Engineered Enzymes

Earlier held misconceptions about biocatalysis such as yield, reliability, scalability are now readily addressable by enzyme engineering & process development.

Alcami: Connected at Every Level

"Connected at Every Level" communicates integration through science and philosophy.

Single-Use Equipment Proving Useful Managing Biomanufacturing Costs

With options for both upstream and downstream processes, the flexible factory concept is becoming the model for cost-effective, aseptic production.

Scale-Down Models: An Indispensable Tool to Biopharmaceutical Process Development

Scale-down models are increasingly adopted by the industry & serve as an indispensable tool for process development, characterisation & validation.

Rigorous Integration in a Scalable Development and Manufacturing Enterprise to Support Continued Growth of Biopharmaceuticals

To attract and keep customers, competitive CDMOs are bolstering their offerings by expanding areas of expertise through forming strategic partnerships.

Integrating Drug Discovery and Development to Improve Efficiency and Candidate Success

To speed up drug development, organisations are integrating discovery & development by conducting interdisciplinary studies in formulation development & DMPK.

Innovation at the Heart of Biopharmaceutical Industry Growth

The global biopharmaceuticals market valued at $162 billion in 2014, is predicted to grow at a compound annual growth rate of 9.4% from 2014 to 2020.

Biosimilars: Are We on the Edge of a New Era of Biologics?

Much of biosimilars’ market potential will depend on insurers' willingness to pay for these medications & pricing will be similar to current biologics pricing.

Achieving Large-Scale Cell and Gene Therapy Manufacturing

A rich pipeline of over 500 cell and gene therapy products currently in the clinical trials, will drive significant capacity needs in the future.

Brammer Bio: Manufacturing Personalized

Brammer's brand identity was created with a visual allusion to cells.

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