Manufacturing Archives - Industry Standard Research

Highly Potent API Manufacturing Market Outlook: 2024 - 2029

Manufacturing

Highly Potent API Manufacturing Market Outlook: 2024 – 2029

Report Overview: ISR understands the desire for a deeper dive regarding the small and emerging biopharma landscape. The needs, practices, and perceptions of outsourcers at small and emerging sponsor organizations are not necessarily the same compared to the wider audience…

Brandon Allison

Insights into CDMO Selection from the External Manufacturing Department preview image

Manufacturing Pharmaceutical Department Structures

Insights into CDMO Selection from the External Manufacturing Department

Report Overview: ISR conducted 14 in-depth interviews with professionals who work in the External Manufacturing department at biopharmaceutical companies of various sizes (based on employee numbers and revenue) in the US and Europe. The objective of the interviews was to…

Brandon Allison

Small Molecule Drug Product CDMO Benchmarking (7th Ed.)

Manufacturing

Small Molecule Drug Product CDMO Benchmarking (7th Ed.)

Report Overview: ISR’s Small Molecule Drug Product CDMO Benchmarking (7th Edition) report brings with it a wealth of knowledge and information, created with two goals in mind: to help biopharmaceutical companies make more informed CDMO decisions, and to help CDMOs…

Brandon Allison

Small Molecule API CDMO Benchmarking (9th Ed.)

Manufacturing

Small Molecule API CDMO Benchmarking (9th Ed.)

ISR’s Small Molecule API Contract Manufacturing Quality Benchmarking (9th Edition) report contains a wealth of knowledge and information created with two goals in mind: to help biopharmaceutical companies make more informed CDMO decisions, and to help CDMOs optimize operational and…

Brandon Allison

Navigating Cell Therapy Supply Chain Challenges

Manufacturing

Navigating Cell Therapy Supply Chain Challenges

Report Overview: Various factors are contributing to the storage and distribution of clinical trial materials becoming more complex. Ironing out the complexities of clinical logistics can help bring a drug to market faster. The clinical supply process brings on a…

Brandon Allison

Biologic Drug Product CDMO Benchmarking (7th Ed.)

Manufacturing

Biologic Drug Product CDMO Benchmarking (7th Ed.)

Industry Standard Research (ISR) takes pride in our suite of Quality Benchmarking work and this study is no exception. The Biologic Drug Product CDMO Benchmarking (7th edition) has a wealth of information, created with two goals in mind: (1) Help…

Brandon Allison

Biologic API CDMO Benchmarking (9th Ed.)

Manufacturing

Biologic API CDMO Benchmarking (9th Ed.)

ISR’s Biologic API CDMO Benchmarking (9th Edition) report brings with it a wealth of knowledge and information created with two goals in mind, help biopharmaceutical companies make more informed CDMO decisions, and help CDMOs optimize operational and marketing strategies. This…

Brandon Allison

2023 Cell Therapy CDMO Benchmarking

Manufacturing

2023 Cell Therapy CDMO Benchmarking

Industry Standard Research (ISR) takes pride in our suite of Quality Benchmarking work and this study is no exception. The inaugural Cell Therapy CDMO Benchmarking has a wealth of information, created with two goals in mind: (1) Help cell therapy…

Technologies & Capabilities in Demand for Oral Dosage Forms Manufacturing

Manufacturing

Technologies & Capabilities in Demand for Oral Dosage Forms Manufacturing

Outsourced Manufacturing for Oral Dosage Forms From the commonly available tablets and capsules to more specialized forms like bi-layer and chewables, oral dosage forms remain the most popular drug products on the market. In this highly competitive and flourishing landscape,…

Brandon Allison

Gene Therapy Timelines & CDMO Selection Attributes

Manufacturing

Gene Therapy CDMO Timelines & Selection Attributes

The Long Road to Approval for Gene Therapies We’ve come a long way from the first gene therapy clinical trial in 1990, but for all the hurdles overcome and advancements made, timelines remain one of the most prominent pain points…

Brandon Allison

Manufacturing

How Do Outsourcers Feel About The CDMO Industry?

Industry Standard Research (ISR) regularly partners with The Rational Heart (TRH), a research organization focused on understanding how customers and prospects actually feel about their brand. ISR conducts this type of study for our clinical research and contract manufacturing clients…

Manufacturing

Oral Dosage Forms Market Outlook (5th Ed.)

Oral Dosage Forms Market Outlook (5th Ed.) Oral dosage forms have a long history and enjoy market dominance, making this category of drug product a strong candidate for outsourced manufacturing, including to CMOs in emerging markets. This report provides an…

2023 Gene Therapy CDMO Benchmarking Thumbnail

Manufacturing

2023 Gene Therapy CDMO Benchmarking

2023 Gene Therapy CDMO Benchmarking Industry Standard Research (ISR) takes pride in our suite of Quality Benchmarking work and this study is no exception. The inaugural Gene Therapy CDMO Benchmarking has a wealth of information, created with two goals in…

Manufacturing

Exploring the Integral Role of CMC in Small and Emerging Biopharma

The Chemistry, Manufacturing, and Controls Function In the dynamic world of biopharmaceuticals, small and emerging companies play a vital role in driving innovation and advancing groundbreaking therapies. While these companies often possess cutting-edge science and promising drug candidates, they may…

Laura McWhinney

Manufacturing Pharmaceutical Department Structures

The CMC Function at Emerging Pharma

The CMC Function at Emerging Pharma Industry Standard Research (ISR) interviewed 15 CMC professionals at pharmaceutical and biotechnology companies, eleven of whom are at small or emerging companies, to better understand the CMC role and function. CMC is integral to…

Manufacturing

Biopharma Outsourcing Trends for Sterile Injectable Manufacturing

Evolving Perceptions and Practices in Sterile Injectable Outsourcing Sterile injectable medicines provide significant advantages in terms of rapid and accurate drug delivery. Many newer medications cannot be produced as an oral dosage form for various reasons, making injectable delivery an…

Brandon Allison

Manufacturing

Which CDMO Traits Predict Sponsor Loyalty When Outsourcing Small Molecule API?

Industry Standard Research’s CDMO Benchmarking reports include loyalty scores for each of the service providers included in the research. ISR computes loyalty as an index that consists of overall satisfaction, willingness to recommend, and likelihood to use again. The loyalty…

Manufacturing

Cell & Gene Therapies Outsourcing Trends

The Growing Cell & Gene Market The outsourced cell and gene manufacturing space has experienced notable expansion and change in recent years. As the advancement of cell and gene therapies continues, drug innovator companies have come to rely heavily on…

Brandon Allison

Articles Clinical Trials Manufacturing

Performance Benchmarking Informs Service Provider Selection

Selecting a CMO or CRO is stressful, expensive, and time-consuming. The complexity of these supplier organizations makes them difficult to evaluate. Far too often, decision makers lack vital information to support selection decisions. But the consequences of selecting the wrong…

Manufacturing

Sterile Injectable Drug Product Manufacturing Market Outlook: 2023-2028

Sterile Injectable Drug Product Manufacturing Market Outlook: 2023-2028 The current landscape for sterile injectable drug product manufacturing is shaped by multiple dynamics, and when the decision has been made to outsource there is no shortage of options: niche CMOs with…

Manufacturing

Cell & Gene Therapies Manufacturing Market Outlook (2nd Edition)

Manufacturing

COVID Continues to Impact Outsourced Manufacturing and Supply Chain Security

Each of the past three years, Industry Standard Research has included questions in its annual CDMO benchmarking research to better understand whether the pandemic has affected drug innovators’ outsourced manufacturing for small molecule drug substance, small molecule drug product, biologic…

Manufacturing

CDMO Performance on Service Provider Selection Criteria

2023 is the 12th year of Life Science Leader’s annual CDMO Leadership Awards, where contract manufacturers are recognized for their ability to deliver above and beyond the expectations of their drug innovator clients. The awards are the result of sponsor…

Laura McWhinney

Manufacturing Supply Chain & Logistics

Industry Trends: Clinical Trial Logistics Outsourcing

Clinical Trial Logistics Market Dynamics Clinical trials often span numerous sites around the globe and continue to implement more and more decentralized elements, such as in-home visits by healthcare providers. Accordingly, the storage and distribution of clinical trial material has…

Manufacturing

Tracking the Evolution of CDMO Selection Criteria for Biologic Drug Substance Manufacturing

Biologic drug substance developers face an ever-evolving slate of challenges related to CDMO outsourcing. As part of ISR’s CDMO Benchmarking research, respondents are asked to review a list of 28 selection attributes and to identify the one criterion most important…

Manufacturing Supply Chain & Logistics

The Value of Strategic Outsourcing Relationships

The Evolution of Outsourcing Over the past few decades there have been considerable changes in the outsourcing environment; at the outset, pharmaceutical companies were primarily offshoring to lower-cost centers and used different contract manufacturers for different projects in a somewhat…

Manufacturing

How Industry Benchmarks Can Inform CDMO Selection

Biopharmaceutical sponsor considerations when selecting a CDMO may include timelines, cost, regulatory requirements, capacity, quality, risks, and previous experience. To help sponsors better understand and prioritize development and manufacturing elements, ISR conducts four annual, manufacturing-specific benchmark studies that ask professionals…

Laura McWhinney

Manufacturing

Biologic Drug Product CDMO Benchmarking (6th Ed.)

Manufacturing

Small Molecule Drug Product CDMO Benchmarking (6th Ed.)

Manufacturing

Biologic API CDMO Benchmarking (8th Ed.)

Small Molecule API CDMO Benchmarking

Manufacturing

Small Molecule API CDMO Benchmarking (8th Ed.)

Manufacturing

Clinical Manufacturing Market Outlook

Manufacturing

Small and Midsize Biopharma Perspective on the Highly Potent API Manufacturing Market

Clinical Trials Manufacturing

Clinical Logistics Benchmarking

Manufacturing

CDMO Outsourcing Models (4th Ed.)

Manufacturing

Bioprocessing Market Outlook: 2022-2027

Five Steps to CDMO Selection

Manufacturing

Five Steps to CDMO Selection

Sponsors will see success in their CDMO partnerships by dedicating time and effort to establish a plan that identifies outsourcing drivers, to select a model that matches company needs and resources, to establish a decision-making process and group, and to…

Manufacturing

Highly Potent API Market Outlook

Manufacturing

Biologic API CDMO Benchmarking for New & Emerging Biopharma

Manufacturing

Small Molecule Drug Product CDMO Benchmarking (5th Ed.)

Manufacturing

Small Molecule API CDMO Benchmarking (7th Ed.)

Manufacturing

Biologic API CDMO Benchmarking (7th Ed.)

Manufacturing

Biologic Drug Product CDMO Benchmarking (5th Ed.)

This report provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 23 performance attributes specific to outsourced drug product manufacturing.

Manufacturing

Commercial Bioprocessing Market Outlook

Georganne Sanders

Manufacturing

Sterile Injectable Drug Product Manufacturing Market Outlook (3rd Ed.)

Georganne Sanders

Manufacturing

Cell & Gene Therapies Market Outlook

Manufacturing

Oral Dosage Forms Market Outlook (4th Ed.)