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.

Syntegon Enters Into Strategic Partnership with Bayer

The partnership will expand the development of new continuous manufacturing processes for oral solid dosage (OSD) forms.

The Alliance to Zero is an important step on the road to net-zero emissions in the pharmaceutical supply chain.

For a Sustainable Pharma Supply Chain: Schreiner MediPharm Among Founding Members of “Alliance to Zero”

Non-profit partnership seeks sustainability for the pharmaceutical industry.

Pharmaworks Jeff Miller

Jeff Miller Appointed Regional Sales Manager, Central United States and Central Canada for Pharmaworks

Miller will be responsible for bringing Pharmaworks’ blister machines, cartoners, and other packaging systems to pharmaceutical, nutraceutical, medical device and consumer goods manufacturers and contract packers throughout these regions.

Catalent’s OptiDose Design Solution uses a design approach, combining data-driven scientific tools with development expertise.

Catalent: Dose Form Decision Platform

Catalent launches its OptiDose Design Solution to help create differentiated treatments that are successful for innovators, patients, and health care professionals.

'Now more than ever the need for collaboration and communication across stakeholders throughout the product journey is key.”

Cold Chain Logistics: Poised for Growth with Lessons Learned from the Pandemic

As more complex, innovative specialty pharmaceutical products reach the market, including cell and gene therapies, there will be a growing demand for cold chain storage, transport, and distribution solutions.

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Summer Reading Series: Automation and Digital Transformation — Life Sciences

Skipping vacation this week? Using your free time to brush up on what you missed? From reshoring and machine safety to robotics and optimizing inspection with AI, here are seven articles and podcasts highlighting what's new.

Half-stoppered vials, ready to be lyophilized

Shilpa Medicare Expands Oncology Drug Production with Robotic Pilot Line

Robotics increase the flexibility of the machine, allowing for processing of vials, pre-filled syringes (PFS), and cartridges with minimal format changes and a small footprint.

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How and Why Pharmaceutical Manufacturers Are Applying Artificial Intelligence

From early identification of process degradation to quality inspection optimization, artificial intelligence can make a dramatic impact on a company’s competitive advantage, as evidenced by pharma industry applications.

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Human Factored Design Influences the Healthcare Industry

Anticipating end-user needs has become commonplace in packaging and product design.

In addition to PlasmaPatch, Patch-Safe (above right), the display protection film (below right) and the adhesive moped plate (below left) won recognition in the FINAT Awards competition.

PlasmaPatch for Wound Healing Wins Innovation Award at 2021 FINAT Awards

Schreiner Group celebrated an outstanding success in as many as four different categories. The prestigious Innovation Award went to PlasmaPatch from Schreiner ProTech using printed electronics for wound healing.

Digital Transformation Breakdown at the 2021 PDA Annual Meeting

The benefits of data collection, management techniques, and practices took center stage in a number of sessions at the 2021 Parenteral Drug Administration Annual Meeting. Learn about the latest developments from PDA's meeting in this Take Five video.

Your CDMO Partner for Finished Products

Your CDMO Partner for Finished Products

When your development, manufacturing, packaging, quality, and delivery needs call for an all-inclusive partner, Sovereign Pharmaceuticals is here. We offer the highest quality contract manufacturing solutions.

Pro Mach Pharma Adam Rosenthal

ProMach Appoints Director of Pharma Marketing

Adam Rosenthal was appointed to the new position of Director of Marketing, Pharma business line for ProMach.

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Civica to Build an Essential Medicines Manufacturing Facility in Virginia

The new facility, part of a partnership with Virginia-based Phlow Corp., will employ more than 180 people and will help ensure a safe, stable, and affordable supply of essential generic medicines for U.S. patients.

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.

The 600 square meter building is set up for formulation, development, and production of the company’s oral solid dosage (OSD) forms–from cleanrooms and assembly areas to offices, meeting, and training rooms.

Syntegon Opens OSD Customer Center in Waiblingen

From development to production of oral solid dosage forms, the center is outfitted with pharmacists, chemists, engineers and process specialists.

More in Pharmaceutical

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.

The combination of Flexi-Cap and Booklet-Label blinds the vial and offers ample space for product information in several languages.

CSL Behring Uses Specialty Label System to Blind Vials for Clinical Trials

There are visible differences between the candidate and the placebo in this international Phase III trial. The blinding system combines a cap system that completely covers the vial with a booklet label for multilingual product information.

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.