Newsletter | June 15, 2022

06.15.22 -- Breaking Down The CDMO Size Barrier

From The Editor
Featured Editorial
Industry Insights
Expanding The Boundaries Of Subcutaneous Injections

As the field of biologics increases its focus on identifying new diseases to target and novel constructs to treat them, innovative administration devices are once again in the spotlight.

Which Testing Does An Effective Certificate Of Analysis Include?

Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

Oral Solutions And Suspensions: The Art Of Pharmacy

Despite advantages, there are challenges associated with liquid dosage, such as stability and palatability, parameters that need to be considered in the design.

Small Molecule Orphan Drugs: Balancing Financial Incentives, Complex Challenges

Changing the lives of patients living with rare diseases requires collaboration, communication, and careful planning that incorporates regulatory, clinical, scientific, and commercial strategy. It also requires a commitment to advancing science to speed solutions.

Top Four Considerations For Tech Transfer Performance

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.

Gap Analysis: How Objective Review Benefits Biopharma Clinical Quality Systems

A comprehensive gap analysis examines documented procedures, SOPs, and QMS processes, but also includes discussions with key personnel and scrutinizes outputs derived from those SOPs and processes. Learn about the “report card” — an independent key deliverable that helps the organization identify, prioritize, and remediate potentially problematic areas.

Current And New Technologies To Characterize Advanced Therapies: Making The Right Decisions Upstream To Ensure Downstream Success

Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.

Performance Of Novapure Plungers For Syringes In Autoinjector Systems

When moving from vial systems to prefilled syringes and autoinjector systems, factors to consider include patient and caregiver needs, drug product requirements, system components, and performance.

Curing Your Complex Oral Solid Dose Challenges

Oral solid dose experts Amy Trotch and Kieran Coffey offer insight into OSD coating techniques and technologies, and how to effectively scale and transfer them for commercial manufacturing. 

Clinical Manufacturing: What It Is And How It Works

Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for use in clinical research. How does it work and how is it different from commercial manufacturing?

Building A Bridge Of Equivalence To Facilitate And Implement Rapid Process Changes In Gene Therapy Manufacturing

A clear path for establishing equivalency is needed to facilitate more rapid advances in the gene therapy field and ultimately to enable lower-cost gene therapies that reach patients faster than ever.

Lyophilized Products Are On The Rise: What You Need To Know

There is increased demand for lyophilization services in the manufacturing of new biologic drugs and injectable formulations as well as in change of formulation presentation.

Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval?

Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future filled with uncertainty and disruption.

The Advantages And Challenges Of Fixed-Dose Combination Products

Understanding the significant competitive advantages of FDC products and the difficulties and potential pitfalls associated with their development and manufacturing in oral solid dosage forms is critical.

Business Continuity Program: Maintain Operations During Crises

Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations through a crisis situation.

Post-Discovery Priorities: Streamlining Your Molecule’s Route To IND

Four experts in post-discovery strategy share insights into methodologies, robust platform process design, high-throughput automation technologies, optimized workflows, and life cycle approaches.

Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies

Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologic drug product tech transfer.

New Podcast Episode
Upcoming Industry Webinars
Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

June 22, 2022 | 11:00 a.m. Eastern Daylight Time

Dr. Kimberly Shepard, a principal R&D engineer at Lonza, will offer insights on recent innovations pioneered in spray drying. Shepard will also discuss spray-drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.

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