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Avid Bioservices to Report Financial Results for Third Quarter of Fiscal Year 2021 After Market Close on March 8, 2021

Retrieved on:

Monday, March 1, 2021

Members of Avid's senior management will discuss financial results for the third quarter and review recent corporate developments.

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Members of Avid's senior management will discuss financial results for the third quarter and review recent corporate developments.
To listen to the live webcast, or access the archived webcast, please visit: http://ir.avidbio.com/investor-events .
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.
The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.

Cascade Chemistry Initiates $14 Million Expansion of cGMP Pharmaceutical Manufacturing Capacity

Retrieved on:

Thursday, February 18, 2021

Cascade Chemistry, a leading pharmaceutical contract development and manufacturing organization, today announced initiation of construction of new facilities designed to increase the companys capacity to manufacture APIs (active pharmaceutical ingredients) under cGMP (current Good Manufacturing Practices standards and procedures).

Key Points:

Cascade Chemistry, a leading pharmaceutical contract development and manufacturing organization, today announced initiation of construction of new facilities designed to increase the companys capacity to manufacture APIs (active pharmaceutical ingredients) under cGMP (current Good Manufacturing Practices standards and procedures).
View the full release here: https://www.businesswire.com/news/home/20210218005056/en/
Eugene, OR-based Cascade Chemistry initiated construction of a $14 million facility to significantly increase its cGMP pharmaceutical manufacturing capacity.
This $14 million expansion reflects our growing success as a reliable, experienced and flexible outsourcing partner with exceptional chemistry problem-solving expertise, said Jeremiah Marsden, PhD, President of Cascade Chemistry.
Cascade Chemistry Is Hosting a New Facility Groundbreaking:
Cascade Chemistry specializes in active pharmaceutical ingredient (API) process development, scale-up and cGMP (current Good Manufacturing Practices) manufacturing.

Century Therapeutics Significantly Expands Capabilities with New Operational, Laboratory and Manufacturing Facilities in Pennsylvania and New Jersey

Retrieved on:

Wednesday, February 17, 2021

Life sciences, Health sciences, Branches of biology, Stem cells, Fujifilm, Cell therapy, Cellular, CGMP, Therapy

Century has also signed a lease to build their ownin-house cGMP manufacturing facility in Branchburg, NJ, with the goal of being operational later this year.

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Century has also signed a lease to build their ownin-house cGMP manufacturing facility in Branchburg, NJ, with the goal of being operational later this year.
This capability will supplement existing privileged access to the Fujifilm Cellular Dynamics (FCDI) facilities and power a rapidly growing pipeline of cellular products.
"Adding in-house manufacturing capabilities will enable us to generate our pipeline with homogenous products that can be manufactured and scaled in a cost-effective manner," adds Dr. Flores.
Century Therapeutics is harnessing the power of stem cells to develop curative cell therapy products for cancer that overcome the limitations of first-generation cell therapies.

NKMax America Announces Key Leadership Appointment

Retrieved on:

Thursday, February 4, 2021

Articles, Business, Economy, Chief operating officer, Corporate governance, CGMP, Chief technology officer, COO

As our Chief Technical Officer, Stephen has been critical to establishing our cGMP-compliant manufacturing facility and is a proven and impactful leader in our dynamic organization, said Sangwoo Park, Chairman and Chief Executive Officer of NKMax America.

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As our Chief Technical Officer, Stephen has been critical to establishing our cGMP-compliant manufacturing facility and is a proven and impactful leader in our dynamic organization, said Sangwoo Park, Chairman and Chief Executive Officer of NKMax America.
In his new role as COO, Mr. Chen will be responsible for overseeing the business operations and providing strategic leadership while retaining his current responsibilities as Chief Technical Officer.
Mr. Chen has more than 16 years in operational leadership in the areas of quality assurance, quality control, laboratory operations, and GMP manufacturing.
NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity.

Humanigen and Avid Bioservices Enter into cGMP Manufacturing Agreement for COVID-19 Therapeutic Candidate Lenzilumab in Support of Potential EUA Filing

Retrieved on:

Wednesday, February 3, 2021

Pharmaceutical industry, Life sciences, Health sciences, Health, Validation, Contract manufacturing organization, CGMP, Biopharmaceutical, Good manufacturing practice, Therapure BioPharma Inc

Under the terms of this Current Good Manufacturing Practice (cGMP) agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering cGMP drug substance batches to support Humanigens regulatory and potential commercial activities.

Key Points:

Under the terms of this Current Good Manufacturing Practice (cGMP) agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering cGMP drug substance batches to support Humanigens regulatory and potential commercial activities.
At Avid, we are proud to play our part in these important efforts, saidTimothy Compton, chief commercial officer of Avid.
Lenzilumab is an exciting COVID-19 therapeutic candidate and the type of complex biologic for which Avid possesses decades of manufacturing success.
Avid Bioservicesis a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical drug substances derived from mammalian cell culture.

DGAP-News: Eckert & Ziegler to Build cGMP Facility for Radiopharmaceutical Services in USA

Retrieved on:

Thursday, January 28, 2021

CGMP

This new cGMP clean room suite will be a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility dedicated to late stage investigational and commercial stage radiopharmaceuticals.

Key Points:

This new cGMP clean room suite will be a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility dedicated to late stage investigational and commercial stage radiopharmaceuticals.
Together with our current facilities in Germany, the new U.S. based cGMP facility, will enable Eckert & Ziegler to provide radiopharmaceutical development services to companies looking for US and worldwide contract manufacturing.
"To meet the growing global demand for radiopharmaceutical services involving both imaging and therapy products, we have decided to make this investment.
"With the new cGMP facility, we offer both regional and global pharmaceutical companies a one-stop service for a variety of radio-pharmaceutical services under cGMP conditions."

Novan Provides Enrollment Update and Announces New Corporate Headquarters

Retrieved on:

Tuesday, January 19, 2021

CGMP, Molluscum contagiosum

The Company is building out the newly leased location to support various cGMP activities, including research and development and small-scale manufacturing capabilities.

Key Points:

The Company is building out the newly leased location to support various cGMP activities, including research and development and small-scale manufacturing capabilities.
We are grateful to all the investigators and staff who are driving enrollment for this important program forward, as well as the molluscum patients for their ongoing support.
If approved, we believe that SB206 would help meet the need for patient care with an at-home treatment, commented Paula Brown Stafford, President and Chief Executive Officer of Novan.
We believe these steps position us to build momentum and enter the next phase of growth for the Company.

Alcami Expands Oral Solid Capabilities with Investment in Wilmington

Retrieved on:

Thursday, January 7, 2021

Pharmaceutical industry, Contract manufacturing organization, CGMP, Wilmington, North Carolina, East Coast of the United States

WILMINGTON, N.C., Jan. 7, 2021 /PRNewswire/ -- Alcami, a leading United States-based contract development and manufacturing organization (CDMO), announced an additional $2 million investment to expand its oral solid development and manufacturing capabilities in Wilmington, NC.

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WILMINGTON, N.C., Jan. 7, 2021 /PRNewswire/ -- Alcami, a leading United States-based contract development and manufacturing organization (CDMO), announced an additional $2 million investment to expand its oral solid development and manufacturing capabilities in Wilmington, NC.
The investment will add a Gerteis Mini-Pactor roller compactor and low humidity suites to Alcami's existing 140,000 square foot campus in Wilmington, NC.
Alcami's cGMP oral solid manufacturing technologies are arranged in flexible suites designed for novel, advanced, and complex projects.
Leveraging four US-based scientific campuses, Alcami serves biologics and pharmaceutical companies of all sizes providing customizable and innovative solutions for development, clinical to commercial sterile and oral solid manufacturing, packaging, and stability services.

Taysha Gene Therapies Expands Leadership Team to Deepen Manufacturing and Communications Capabilities

Retrieved on:

Tuesday, December 29, 2020

Biotechnology, General Health, Other Health, Health, Pharmaceutical, Health sciences, Life sciences, Drug discovery, Health policy, Medicinal chemistry, Therapy, CGMP

We are excited to welcome Greg and Kim to Tayshas leadership team, said RA Session II, President, Founder and CEO of Taysha.

Key Points:

We are excited to welcome Greg and Kim to Tayshas leadership team, said RA Session II, President, Founder and CEO of Taysha.
Gregs technical expertise in AAV gene therapy manufacturing along with his proven success in constructing several cGMP gene therapy facilities and Kims deep experience across capital markets and corporate communications will add tremendous value to the team.
Mr. Gara has over 25 years of experience in designing, constructing, and starting up large- and small-scale manufacturing facilities for biotechnology companies globally.
Prior to joining Taysha, he served as Vice President of Pharmaceutical Engineering at Sarepta, where he led and managed manufacturing operations for all gene therapy products.

Passage Bio Announces Gene Therapy Manufacturing Research and Development Site

Retrieved on:

Wednesday, December 16, 2020

Catalent, Gene therapy, Life sciences, CGMP, Economy of the United States, Biotechnology

The CMC laboratory complements the recent opening of Passage Bios dedicated CGMP manufacturing suite at Catalent.

Key Points:

The CMC laboratory complements the recent opening of Passage Bios dedicated CGMP manufacturing suite at Catalent.
These investments provide the company with the foundation for an integrated manufacturing supply chain with robust capabilities to advance multiple gene therapy programs to support clinical trials worldwide.
Passage Bio has leased approximately 62,000 square feet of lab space at the Princeton West Innovation Campus which is intended to support analytics, process development, quality control and pilot manufacturing.
The 1.2 million-square-foot, multi-purpose research and development and biologic/pharmaceutical manufacturing campus also provides Passage Bio with readily available expansion opportunities for additional lab space and CGMP manufacturing operations to support long-term growth in the companys gene therapy pipeline programs.