Newsletter | August 8, 2019

08.08.19 -- Is Continuous Manufacturing A Good Fit For Generic Drug Products?

Featured Editorial
Is Continuous Manufacturing A Good Fit For Generic Drug Products?
By Ajay Pazhayattil, et al

Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector.

3 Surefire Approaches To SOP Harmonization
By Penelope Przekop

We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

Industry Insights
Improving Compliance And Manufacturing Efficiency In Life Sciences
White Paper | By Dan Jacob, Dassault Systemes Americas

Current market conditions, such as regulations and mergers or acquisitions, make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. 

Key Concepts Driving The Future Of Single-Use In Biopharma Production
White Paper | By Matthew Olsen, Sartorius Stedim Biotech

This article discusses four topics related to single-use bioprocessing that are commonly cited by end users as amenable to future development. 

Meeting Regulatory Requirements With A Trusted Equipment Partner
White Paper | By Adam Covitt, Federal Equipment Company

Pharmaceutical suppliers are tasked with responding to ever-evolving changes in regulatory requirements, which impact everything within an organization — from operations to the way trials are conducted.

Choose The Right Inline High-Shear Mixer For Your Process
White Paper | By Christine Banaszek, Charles Ross and Son Company

This white paper presents some ideas for selecting the right inline high-shear mixer for your process based on a company’s collective experience as a mixing equipment provider to process industries.

The Transparent CDMO: Maintain Autonomy In Biomanufacturing Partnership
Article | By Patrick Guertin, GE Healthcare Life Sciences

Complete transparency and open communication are both critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?

Prefilled Syringe Leak Detection With Vacuum Decay vs. HVLD Test Methods
Case Study | By Oliver Stauffer, PTI Packaging and Inspection Systems

The study addresses the common concern that vacuum decay is not a suitable test solution for detecting microleaks in parenteral containers if the product contains large molecule or proteinaceous liquids.

Cultural Audits: What Are They And Why Are They Essential?
Article | B. Braun OEM Division

The medical device industry is familiar with quality audits but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table.

Inspecting On The Edge: Understanding Punch Tip Wear
White Paper | Natoli Engineering Company, Inc.

Avoid production quality-related issues by understanding and knowing how to identify the most common causes of punch tip edge wear.

Fentanyl Exposure: Will Your Containment System Keep You Safe?
Infographic | Flow Sciences Inc.

Fentanyl is one of the strongest and most deadly drugs to reach the public for illegal drug use. This has reached the lab safety industry and forced users to ask if their containment system will keep them safe?

Key Considerations For A Successful EU Orphan Drug Launch
Webinar | Almac Group

During this interactive webinar, the speakers involved will utilize their experience to guide you through the EU product launch process, from submitting your marketing application (MA) to final distribution of drug product to the end user.

  PDA Regulatory Training Course Series

September 20, 2019 | Washington, DC


Following the 2019 PDA/FDA Joint Regulatory Conference, dive into the regulatory details with your choice of seven training courses! Choose from training courses on CMC regulatory requirements in drug applications, sterile manufacturing, root cause investigations, quality and compliance management for virtual companies, cybersecurity risk management, and change management.

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