FDA Cracks Down on StemGenex for a Myriad of Issues

The San Diego-based biologic company was marketing an unapproved stem cell product manufactured in a questionable facility.

Nov 19th, 2018

StemGenex Facility / Image: StemGenex

StemGenex Facility / Image: StemGenex

A recent FDA News Release brought to light some issues associated with San Diego’s StemGenex Biologic Laboratories LLC. Apparently the company was marketing an unapproved stem cell product and was in violation of good manufacturing practices. Investigators revealed 11 different violations at the firm’s facility including failures to follow procedures for preventing microbiological contamination of drug products purporting to be sterile.

StemGenex was also cited for not having a quality control unit since the beginning of 2012, and improper procedures for managing written and oral complaints. This is just the latest in the agency’s ongoing effort to crack down on producers of unapproved stem cell products.

Companies in the life sciences industry need a granular view of the flow of products traveling through the supply chain, from the initial supplier to the patient.

Consequences of Supply Chain Blind Spots and Solutions in New Survey

Companies lose millions due to spoilage; improved tracking methods increase end-to-end visibility and mitigate loss.

Honeywell’s services will reduce total cost of ownership, increase production rates, extend the life and performance of its systems and improve response to changing business demands.

Remote Control System Migration Completed Successfully

Remote migration of process control system using limited onsite staffing and resources used comprehensive services to reduce time and effort to modernize control hardware and software and improve overall migration experience.

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Pharmaceutical & Medical Devices | Webinar | Dec. 9

3 out of 4 pharmaceutical and medical devices companies predict spending more on capital equipment in the next 12-24 months. Learn more about PMMI Business Intelligence findings for this market.

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Pharma and Medical Device Capital Equipment Investments to Grow

PMMI Business Intelligence research shows 3 out of 4 companies interviewed plan to spend more on capital equipment in the next 12-24 months.

The company plans to continue its expansion through investments in product innovation and industrial automation and digitalization in order to increase its pharmaceutical and nutraceutical packaging range.

Bormioli Pharma Acquires German Company ISO GmbH

Acquisition increases production capacity for packaging for parenteral drugs and further consolidates company’s growth and expansion plan that began in 2019.

Hygienic Design Standard Parts for Medical Applications

Hygienic Design Standard Parts for Medical Applications

Standard Parts in Hygienic Design are optimized for minimal contamination and easy cleaning. JW Winco decided to develop a special series of Standard Parts that meet the high requirements. Learn more at jwwinco.com

From top: Jeff Tucker, Tucker Company Worldwide; Kevin Lynch, Q Products and Services; Luiz Barberini, Bayer

Four Tips for Collaborating with Contract Organizations for Increased Efficiency

A Bayer supply chain expert discusses the personal side of managing CMO relationships.

Fewer Ampoule Rejects with Automated Inspection

Pharmaceutical manufacturer CDM Lavoisier decided to fully automate its inspection process for injectable glass ampoules, using the new AIM 3000 from Syntegon Technology.

The labeling and serialization equipment segment is expected to witness the fastest growth during the forecast period.

Growth of Pharmaceutical Packaging Equipment Market Driven by OTCs, Generics, and More

The global pharmaceutical packaging equipment market size is projected to increase at a CAGR of 7.4% from $7.3 billion in 2020 to $10.4 billion by 2025.

Aphena Pharma Completes $7M Expansion

Three new state-of-the-art pharmaceutical blending suites are ready for new products.

LKH Prime 10 UltraPure pump

Advancing Competitive Edge for Biotech and Pharma

Hygienic, sustainable systems that conserve energy for efficiency, productivity and end-user quality.

Hygienic Design Standard Parts for Medical Applications

Hygienic Design Standard Parts for Medical Applications

Standard Parts in Hygienic Design are optimized for minimal contamination and easy cleaning. JW Winco decided to develop a special series of Standard Parts that meet the high requirements. Learn more at jwwinco.com

Pharma Packaging Trends Webinar (1)

Pharma Packaging Innovations

New webinar covers several unique packaging innovations to overcome challenges such as child resistance/senior friendly, on-the-go convenience, anti-counterfeiting and improved packaging functionality.

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CPhI Festival of Pharma 2020 in October

Former FDA commissioner Dr. Scott Gottlieb to address industry on sustainable innovation at the two-week long event. Sessions will cover affordable medicines, supply change resiliency, AI, Vaccine production, and more.

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Liveo Research Announces Capacity Expansion

Liveo Research announces 20,000 ton capacity expansion for coated barrier films to significantly expand pharma packaging business.

Monique Sprueill of Johnson & Johnson addresses supply chain management for ATMPs.

Innovative Therapies Demand Data and Risk Management in Supply Chain

Gene and cell therapies delivered to patients struggling for their lives further complicate an already complicated supply chain. Data and analytics throughout the process are essential to maintaining the integrity needed.

HDA Celebrates Manufacturers With 2020 DIANA Awards

Climate Change Interest Isn’t Ideology, It’s Economics

Economics is the new driver of climate change initiatives, according to Reusable Packaging Association. Attention to packaging selection and management can not only help reduce negative sustainability impacts, but also create new value streams.

Bormioli Pharma Invests in Type I Glass Vial Production for Injectable Medicines and Vaccines

Recent investments will allow Bormioli Pharma to better support pharmaceutical industry demand, especially during such unprecedented, challenging times.

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Collaboration Key to Tackling Drug Development Complexity

Rentschler Biopharma and Vetter team up with joint goal to simplify processes and optimize time-to-market.

More in Pharmaceutical

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Covectra Enhances Drug Supply Chain Security

Automates management of resalable returns & DSCSA product verification compliance to protect consumers from counterfeit, contaminates or stolen drugs.

Labs 131 Instron

Ready-to-Use and Development Services Grow with Injectables Market

Challenges around injectable products include regulatory requirements, pricing pressures, and an increasingly complex industry landscape.

A wide variety of process steps are required for the filling of vaccines – from washing and sterilizing the vials to filling and closing. All system components are tested and accepted as part of the CSPE approach at Optima in Schwaebisch Hall.

OPTIMA Supporting Catalent with New High-Speed Vial Filling Line for COVID-19 Vaccine Program

Fast track delivery of a complete filling solution under isolator

The GKF 2600, which was developed for the high-performance range, achieves an output of more than 110,000 capsules per hour with capsule size 00.

Pharma Contract Manufacturer Expands Large Batch Production to 110,000 Capsules Per Hour

Wiewelhove expands capsule filling line, enabling the company to fill pellets into capsules with the GKF 2600 from Syntegon Technology. Collaboration on special requests led to a smooth implementation.

Gregor Anderson, MD of Pharmacentric Solutions

Pharmapack Expert Recommends Holistic Approach to Sustainability

Encouragingly, the industry might be 30% along its sustainability journey, but greater interoperability is needed from materials to devices for next stage of development.

Peter Buczynsky, Vice President & General Manager of Pharmaworks blister packaging machinery with PPE face shield.

Packaging Industry fights Covid-19

ProMach company launches collaborative packaging industry effort to donate protective face shields

ACG has received a certification of compliance from Clean Label ProjectTM for its ACGcapsTM H+.

ACG Receives Certification for its ‘Clean Label’ Capsules

ACG is the first and the only capsule manufacturer at this time to receive the certification.

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Healthcare Market Equipment Investments Poised for Growth in 2021

Personal care and pharmaceuticals /medical devices are two markets that, not surprisingly, are holding their own and even expecting growth during COVID-19.

Syntegon Virtuelle Messe

Syntegon Unveils Sustainable, Intelligent Machine Design

Following a major corporate rebranding, the food and pharma packaging OEM launches its first virtual show as a platform to introduce new products and interact with customers.

Midol Before After[1]

Redesign Reverses Course to Reflect Modern Women

Midol®, the venerable OTC menstrual relief brand from Bayer, underwent a striking packaging redesign, reversing course on existing iconography, typography, and messaging.

The coronavirus pandemic is also set to boost the geriatric medicines market.

COVID-19 to Boost Market Prospects for the Global Geriatric Medicines Market

Report foresees positive growth in the geriatric medicines market at a CAGR of 6% from 2020 through 2026.

The state-of-the-art coating line has increased kp’s local South American coating capacity by over 30%

Klӧckner Pentaplast Completes Major Pharma Capacity Expansion in Cotia, Brazil

Expansion provides additional coating capacity and reduces the site’s carbon footprint and overall energy consumption.