Resources and Industry Insights

Life Sciences Resources for Drug, Biologic, and Combination Product Development

Explore articles, webinars, videos, courses, and technical resources from Pharmatech Associates.

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Developing a Biosimilar Candidate

Developing a Biosimilar Candidate

Biosimilar development hinges on one central challenge: demonstrating that a proposed biosimilar is highly similar…
Digital illustration of a pharmaceutical capsule and molecular data
What the Biosimilars Industry Is Really Saying Right Now

What the Biosimilars Industry Is Really Saying Right Now

Insights from the Access AAM Panel: Portfolio Strategy, Policy Shifts, and the Road Ahead The…
Vaccine manufacturing line
Cell and Gene Therapy: Opportunities and Risks for Manufacturers

Cell and Gene Therapy: Opportunities and Risks for Manufacturers

Cell and gene therapies (CGTs) are among the world’s most expensive therapies to develop, manufacture,…
Professional reviewing documents and regulatory information
Navigating Regulatory Considerations for Pharma Startups

Navigating Regulatory Considerations for Pharma Startups

On average, it takes 10-15 years — and costs between $43.4 million and $4.2 billion…
Scientist reviewing quality control data on a computer
Quality vs. Compliance in Pharma: Understanding the Difference

Quality vs. Compliance in Pharma: Understanding the Difference

Pharmaceutical and biotech companies struggle with the difference between quality and compliance. It’s understandable. They’re…
Digital illustration of pharmaceutical capsules and data
How to Craft and Maintain a Robust Data Integrity Program

How to Craft and Maintain a Robust Data Integrity Program

With increasingly digital supply chains, the amount of global data is rapidly increasing. For pharma…
Scientist reviewing pharmaceutical manufacturing data on computer screens
Optimizing Your mAb Program: Proven Strategies for Success

Optimizing Your mAb Program: Proven Strategies for Success

Monoclonal antibodies (mAbs) have become a major class of therapeutic agents on the market and represent…
Pharmaceutical quality professionals reviewing documents in a Scientists working together in a laboratory
Mastering Quality – Building a Strong Foundation for Your Pharma Startup

Mastering Quality – Building a Strong Foundation for Your Pharma Startup

Quality, with its checks and balances, is the foundation and a key to success for…
Professionals reviewing pharmaceutical documents together
How to Increase Efficiency in Cell & Gene Therapy Research

How to Increase Efficiency in Cell & Gene Therapy Research

Cell and gene therapy (CGT) drug sponsors make important program and business decisions every day…
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Is Your Quality Management System (QMS) Keeping Up?

Is Your Quality Management System (QMS) Keeping Up?

Your ability to thrive in a quality-centric culture hinges on having a robust Quality Management…
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Quality Considerations for Aseptic Processing

Quality Considerations for Aseptic Processing

Aseptic manufacturing for medicines has been specified and standardized. Pharmaceutical and biopharmaceutical companies have invested…
Pharmaceutical vials and manufacturing equipment in a laboratory
Applying Process Analytical Technology (PAT) to Support Real Time Release (RTR)

Applying Process Analytical Technology (PAT) to Support Real Time Release (RTR)

PAT supports quality by design (QbD) principles, with opportunities to integrate real-time process analytics into…

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60% More Yield From the Same Purification Train

60% More Yield From the Same Purification Train

A biologics purification train (Protein A capture through final concentration) had to be optimized end-to-end…
Pharmaceutical manufacturing equipment in an industrial facility
A 200,000× Leap With No Room for Error

A 200,000× Leap With No Room for Error

A monoclonal antibody process had to move from a 0.1-liter lab vessel to a 20,000-liter…
Pharmaceutical manufacturing equipment in a cleanroom
Comprehensive Assessment Leads to FDA Alignment

Comprehensive Assessment Leads to FDA Alignment

A biosimilar sponsor engaged Pharmatech for process development and validation planning. We aligned their cell…
Scientists reviewing digital pharmaceutical research data
Redevelopment Success Without FDA Findings

Redevelopment Success Without FDA Findings

A biologics client needed to transition five therapies from PHSA Section 351 to Section 361.…
Pharmaceutical scientists reviewing data in a laboratory
Eight Programs Transferred Without Delay

Eight Programs Transferred Without Delay

A cell and gene therapy CDMO engaged Pharmatech to relocate manufacturing and analytical processes for…
Woman using an autoinjector in her arm
Dual Pathway Strategy Shortens Approval Timeline by Six Months

Dual Pathway Strategy Shortens Approval Timeline by Six Months

A biologic developer with an autoinjector needed clarity across CDER and CDRH. Pharmatech resolved classification…
Scientist working in a pharmaceutical laboratory
Approval Accelerated by 3 to 6 Months Through Smarter CMC Strategy

Approval Accelerated by 3 to 6 Months Through Smarter CMC Strategy

A client with strong Phase I results sought fast-track designation, where every month of review…
Scientists discussing pharmaceutical research in a laboratory
Six Months to Fast-Track Approval Through Risk-Based CMC

Six Months to Fast-Track Approval Through Risk-Based CMC

A biologics client needed to reach the market quickly on a fast-track candidate. Working together,…
Pharmaceutical scientist working with a colleague
Ending 18 Months Off Market

Ending 18 Months Off Market

A multinational client faced dissolution failures in a spray-dried modified release capsule, losing 10 percent…
Pharmaceutical professional working in a pharmacy
Faster Market Entry Through Smarter Strategy

Faster Market Entry Through Smarter Strategy

A client's new chemical entity showed potential for breakthrough status. Working together, we amended their…
Scientist examining pharmaceutical research equipment
Quality System Remediation Drives Combination Product Readiness

Quality System Remediation Drives Combination Product Readiness

A mid-sized biopharma company engaged Pharmatech to remediate an acquired Quality Management System after a…
Pharmaceutical professionals discussing research in a laboratory
Closing CMC Gaps to Keep a BLA on Schedule

Closing CMC Gaps to Keep a BLA on Schedule

A client’s BLA was exposed by a complex glycan profile and unresolved CMC gaps that…

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Quality Management Systems: FDA Instructor-Led TrainingQuality & ComplianceRemediation & GMP ReadinessTechnology Transfer & Capability BuildingUpcoming WebinarsWebinars

Quality Management Systems: FDA Instructor-Led Training

Learn the fundamentals of establishing and maintaining an effective quality management system in a compounding…
September 28–29, 2026 | Seattle, Washington
Capsule with a digital DNA illustration representing pharmaceutical data integrity
Data Integrity: FDA Instructor-Led TrainingQuality & ComplianceRemediation & GMP ReadinessTechnology Transfer & Capability BuildingUpcoming WebinarsWebinars

Data Integrity: FDA Instructor-Led Training

Learn practical tools and processes for protecting data integrity within compounding operations, from data collection…
September 30–October 1, 2026 | Seattle, Washington
Digital illustration of a checklist representing FDA compliance
Biosimilars: Meeting the FDA with Your Biosimilar ProductCGT & Biologics ReadinessCMC & Regulatory Risk ReductionU.S. Market EntryWebinars

Biosimilars: Meeting the FDA with Your Biosimilar Product

Gain practical insights into FDA expectations for biosimilar development and approval. This webinar explores regulatory…
Scientist analyzing pharmaceutical research data
Model-Informed CMC Development of Amorphous Solid Dispersions Using Continuous Melt ExtrusionCMC & Regulatory Risk ReductionTechnology Transfer & Capability BuildingWebinars

Model-Informed CMC Development of Amorphous Solid Dispersions Using Continuous Melt Extrusion

This webinar explores how model-informed CMC development can improve the design and manufacturing of amorphous…
Doctor reviewing digital data and pharmaceutical information
From Experiment to Accepted: How In-Silico is Redefining CMC with Regulatory ConfidenceCMC & Regulatory Risk ReductionWebinars

From Experiment to Accepted: How In-Silico is Redefining CMC with Regulatory Confidence

This webinar explores how in-silico modeling and digital tools are transforming Chemistry, Manufacturing, and Controls…
Pharmaceutical vials moving through a manufacturing line
Solving CGT Manufacturing: Control Strategy as the KeyCGT & Biologics ReadinessCMC & Regulatory Risk ReductionWebinars

Solving CGT Manufacturing: Control Strategy as the Key

This webinar discusses the evolving landscape of cell and gene therapy manufacturing and quality, highlighting…
Digital DNA illustration representing secure and reliable data
Quality Considerations for a Robust Data Integrity ProgramQuality & ComplianceRemediation & GMP ReadinessWebinars

Quality Considerations for a Robust Data Integrity Program

Quality, with its checks and balances, is the foundation and a key to success for…
Pharmaceutical manufacturing equipment in a cleanroom
Entering the U.S. Market: What Does it Take?U.S. Market EntryWebinars

Entering the U.S. Market: What Does it Take?

As the U.S. market, the largest commercial market for pharmaceutical and biologic drugs, focuses on…
Scientist examining a laboratory sample under a microscope
mAbs: Biosimilars from Lab to ClinicalCGT & Biologics ReadinessTechnology Transfer & Capability BuildingWebinars

mAbs: Biosimilars from Lab to Clinical

This session explores the development pathway for biosimilar monoclonal antibodies (mAbs), including regulatory requirements, pharmacokinetic…
Pharmaceutical quality professionals reviewing documents in a Scientists working together in a laboratory
Mastering Quality – Building a Strong Foundation for Your Pharma StartupQuality & ComplianceTechnology Transfer & Capability BuildingWebinars

Mastering Quality – Building a Strong Foundation for Your Pharma Startup

Quality, with its checks and balances, is the foundation and a key to success for…
Gloved scientist handling pharmaceutical vials in a laboratory
Modern Approaches to mRNA ManufacturingCGT & Biologics ReadinessTechnology Transfer & Capability BuildingWebinars

Modern Approaches to mRNA Manufacturing

mRNA market in 2021 grew exponentially due to the success of COVID-19 vaccines by BioNTech,…
Scientist reviewing data on a tablet in a laboratory
Modern Quality Techniques: Patient Centric Processes, Integrated QMS, Regulatory IntelligenceCMC & Regulatory Risk ReductionQuality & ComplianceWebinars

Modern Quality Techniques: Patient Centric Processes, Integrated QMS, Regulatory Intelligence

For an organization to move to and thrive in a culture of quality involves having…
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