2 Day Course: The A to Z’s of Microbial Control, Monitoring and Validation of Water Systems (San Francisco, CA – August 23-24, 2018) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “The
A to Z’s of Microbial Control, Monitoring and Validation of Water
Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and
Personal Care Products” conference has been added to ResearchAndMarkets.com’s
offering.

This course is designed to provide a microbiology-focused education
about all aspects of water systems and how biofilm manages to thrive
there.

Prior microbiological education or training, though a plus, is not a
requirement, since this training is for everyone involved with water
systems, from the lab to utility room operations. The instructor will
provide the necessary background needed to understand this very
important subject matter.

This understanding is essential for the proper design, validation,
operation, monitoring, and maintenance of a high purity water system.
Without this understanding, water system control and monitoring consists
of a set of rules that often don’t work or result in erroneous
monitoring data and can cause everything from very costly and
unnecessary system downtime to patient injury and product recalls.

Agenda

Day 1 (8:30 AM – 4:30 PM)

• Basics of Water System Biofilm Control by Design & Operation
• Successful Water System Sanitization
• Common Sense Water System Validation
• Understanding and Controlling Endotoxin
• Harmonizing vs. Optimizing Water Microbial Testing for System Quality
  Control

Day 2 (8:30 AM – 4:30 PM)

• Microbial Enumeration Issues with High Purity Water Systems
• Reducing Water Microbial Excursions & Improving Investigations
• Water System Investigation “How-To’s” and Example Case Studies
• Leadership in MFG Contamination Control: The Microbiology Lab
• USP Chapter: What USP Says about PW, WFI, Pure Steam & Micro Issues
• Guarding Against Common Pharmaceutical Water System Inspection Pitfalls

For more information about this conference visit https://ift.tt/2FdWvyu

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Tetra Bio-Pharma Signs Landmark Commercialization Term Sheet for its Lead Pharmaceutical Product, PPP001, in Israel

OTTAWA, ONTARIO–(Marketwired – April 24, 2018) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP) (OTCQB:TBPMF), announced today that the Company has signed a first binding term sheet for the marketing and distribution of PPP001 in Israel with Kamada Ltd., a leading pharmaceutical company. The signing of a Definitive Distribution Agreement is expected to follow shortly. PPP001 is being developed to be the first smokable cannabis product for advanced cancer pain available under prescription.

This first international market commercialization agreement represents a significant milestone and a validation of Tetra Bio-Pharma’s business model with a leading Israel-based pharmaceutical company. Israel, like Canada, is considered one of the world leaders in the production and development of cannabinoid-based products. Kamada is a company with two FDA-approved products and an Israeli-based distribution segment that has demonstrated continued growth. Tetra Bio-Pharma intends to work closely with Kamada as PPP001 advances towards regulatory approval and commercial launch in Israel.

Under the terms of the anticipated final agreement, Kamada will be responsible for registering the product, as well as all marketing and distribution, in Israel. Tetra will be eligible to receive certain milestone payments and an undisclosed percentage of the sales of PPP001 generated by Kamada in Israel.

About PPP001

On April 4, 2018, Tetra Bio-Pharma officially started the Phase 3 trial for PPP001 indicated for terminal stage cancer patients with a goal to improving the quality of life of these patients as well as minimizing their pain. PPP001 is being developed to be the first smokable cannabis product for advanced cancer pain available under prescription.

About Tetra Bio-Pharma: Tetra Bio-Pharma (TSX VENTURE:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products. Tetra Bio-Pharma is currently developing a pipeline of five cannabinoid-based products using different delivery systems such as smokable pellets, oral tablets, eye drops and topical ointments. More information at: www.tetrabiopharma.com

Source: Tetra Bio-Pharma

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

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LSNE Announces Acquisition Of PSC Biotech’s Parenteral Manufacturing Facility

LSNE-Madison is a 37,000 square foot multi-product facility that will be used for the manufacturing of final drug products for pre-clinical to Phase III/commercial use.  The facility currently includes a high speed, automated aseptic fill line and a 144-square foot lyophilizer with existing space for additional equipment and the ability to expand to over 100,000 square feet of production space over time. 

The facility will complement LSNE’s existing full-service parenteral manufacturing capabilities, which include vial filling, lyophilization, process development, QC analytical, secondary packaging, stability studies and regulatory support for clinical and commercial products at its three other FDA-inspected manufacturing sites.  This new facility will also increase LSNE’s capabilities to include the terminal sterilization of final product and additional quality control services. 

“This acquisition is a key part of our strategic growth plan to increase our operations and capacity and better serve our customers,” said Matthew Halvorsen, Chief Executive Officer at LSNE.  “We have experienced strong growth and increased demand over the last few years, and as the market continues to expand, we know it is imperative to be able to offer increased scheduling flexibility to existing and new clients. With the support of the Permira Funds, we are increasing our capacity to provide our clients with additional manufacturing redundancy backed by the outstanding level of service that LSNE is known for.”   

“With this acquisition, we are gaining strong talent that complements LSNE’s experienced and successful teams,” says Shawn Cain, Chief Operation Officer at LSNE.  “We look forward to working with the staff to build LSNE-Madison into a world class aseptic fill/finish facility focused on the manufacturing of lyophilized and liquid drug products. “

LSNE anticipates full manufacturing activities to commence later this year, following a short period of renovation and validation of the facility.  Additional information regarding the acquisition and capabilities will be available on LSNE’s website.

About LSNE

LSNE is a privately held company with four GMP facilities – three located in New England and one in Madison, WI.  LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including cycle development, cGMP fill finish, and lyophilization.  Through the thoughtful integration of four processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.

About PSC Biotech

PSC Biotech is global life sciences technology company serving customers in North America, Europe, Asia, South America and the Middle East.  PSC Biotech provides professional technical services such as commissioning, qualification, validation project management, regulatory affairs, quality, compliance, conceptual engineering, Information Technology, metrology services, computerized system validation, etc., to life science, pharmaceutical and software companies.  It also provides world class enterprise quality management software solutions – Adaptive Compliance Engine (ACE) and AuditUtopia.

Media Contact
Christine Palus
Vice President of Sales & Marketing
(603) 668-5763
info@lyophilization.com
www.lyophilization.com

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SOURCE Lyophilization Services of New England

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