Top

Category: Manufacturing


FDA, Manufacturing, Regulations, Research and Development

Lannett Expands Liquid Drug Manufacturing Capabilities

October 31, 2022

Via: Contract Pharma

Lannett Company, Inc. has received approval from the US Food and Drug Administration (FDA) to manufacture Numbrino, the company’s branded topical anesthetic product, at its main plant in Seymour, IN. The company previously manufactured Numbrino and other liquid drug products […]


Manufacturing, Research and Development

Advanced Biopharma Manufacturing Key to White House Cancer Moonshot

September 16, 2022

Via: Biopharm International

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials. An important component of the White House initiative to speed the development of innovative cancer therapies and other critical treatments for […]


Manufacturing, Research and Development

Novartis funnels $300M into early biologic drug manufacturing

September 12, 2022

Via: Biopharma Dive

Novartis will spend $300 million to bolster its development and production capabilities for biologic medicines, which make up an increasing share of its drug pipeline. The Swiss drugmaker will invest $110 million in clinical manufacturing capacity in Mengeš, Slovenia and […]


Manufacturing, Research and Development

Charles River, Cure AP-4 Enter Manufacturing Pact for Gene Therapy

September 6, 2022

Via: Contract Pharma

Charles River Laboratories International, Inc. and Cure AP-4, a non-profit foundation dedicated to raising funds and awareness about Adapter-Protein 4 Hereditary Spastic Paraplegia (AP-4 HSP), have entered a manufacturing collaboration. Charles River, a contract research and development manufacturing organization (CRO/CDMO), […]


Manufacturing, Research and Development

Hovione Expands its Continuous Manufacturing Offering and Services

September 6, 2022

Via: Biopharm International

Hovione announced on September 6, 2022 that it has expanded its continuous manufacturing offering and services with a new manufacturing line, team, and facility. The new continuous manufacturing facility is coming online at the Loures site in Portugal. Hovione is […]


Manufacturing, Research and Development

Streamlining Bulk mAb Manufacturing

September 2, 2022

Via: Biopharm International

With biosimilars entering the market, and more expected to reach the market in the near future, the need for good manufacturing practice (GMP) compliance is growing more crucial for bulk monoclonal antibody (mAb) manufacturing. Beyond innovator biologics, biosimilars are expected […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Forecyte Bio and Cytiva to Collaborate on Cell and Gene Therapy Manufacturing and Development

August 31, 2022

Via: Biopharm International

Cytiva and Forecyte Bio announced on August 25, 2022 that they will collaborate to accelerate the manufacturing and development of the cell and gene therapy industry in China and the United States. The companies will utilize Cytiva’s Fast Trak center […]


Manufacturing, Research and Development

ADHD Drug Adderall in Short Supply

August 29, 2022

Via: Drugs.com

Labor shortages at Teva Pharmaceuticals have made Adderall, a widely used attention-deficit/hyperactivity disorder (ADHD) drug, hard to find in some drugstores. But the U.S. Food and Drug Administration noted that there’s no overall shortage of ADHD medications. Only Teva is […]


Manufacturing, Mergers and Acquisitions, Research and Development

ElevateBio and the Univ. of Pittsburgh Enter Biomanufacturing Partnership

August 26, 2022

Via: Contract Pharma

ElevateBio and the University of Pittsburgh have entered into a long-term partnership to accelerate the development of cell and gene therapies. Through this agreement, ElevateBio will locate one of its next BaseCamp process development and Good Manufacturing Practice (GMP) manufacturing […]


Manufacturing, Research and Development

Fuelling the efficiency of drug development through sensor data integration

August 19, 2022

Via: Pharmaphorum

Connected sensor technologies and tools, from wearables, smart speakers, and bed mats to ingestible sensing capsules and implantables, are capturing unprecedented flows of data with the potential to transform our clinical decision making. Since DiMe’s launch in October 2019, there […]


Manufacturing, Research and Development

Pfizer bid for sickle cell drug developer GBT said to be imminent

August 8, 2022

Via: Pharmaphorum

A deal could be announced as early as today, when GBT is scheduled to report its second quarter results, according to a Wall Street Journal report citing people familiar with the matter. Neither GBT nor Pfizer has commented on the […]


Manufacturing, Research and Development

How Belite Bio, a small, under-the-radar drugmaker, emerged as one of biotech’s best performing IPOs

August 2, 2022

Via: Biopharma Dive

Biotechnology startups are under pressure. After years of plentiful funding, few young drug companies are going public, and those that do are struggling to hold onto their value in a market downturn that’s forcing biotech executives and their venture backers […]


Manufacturing, Research and Development

Cytiva Acquires Chromatography Resins Manufacturing Facility in Muskegon, Michigan

July 19, 2022

Via: Biopharm International

Cytiva has acquired a new chromatography resins manufacturing site in the United States as part of its $1.5 billion capacity expansion investment. Cytiva announced on July 13, 2022 that it had acquired a new manufacturing facility in Muskegon, MI. The […]


Manufacturing, Research and Development

MilliporeSigma to Supply Lotte Biologics with Biologics Manufacturing Capabilities in US

June 29, 2022

Via: Biopharm International

On June 29, 2022, MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced it has signed a non-binding memorandum of understanding (MoU) with the Lotte Group. Under the MoU, MilliporeSigma will collaborate with the new […]


Manufacturing, Research and Development

FDA issues innovative proposal to increase nonprescription drug access

June 28, 2022

Via: PMLiVE

Nonprescription drug treatments are used by consumers without the supervision of a healthcare professional (HCP). When using these treatments, it is up to the consumers to decide if the drug is the correct one for their condition and to ensure […]


Industry, Manufacturing, Research and Development, Vaccines

EU governments pressure manufacturers to renegotiate contracts for COVID-19 vaccines

June 15, 2022

Via: PMLiVE

When vaccines became available earlier in the COVID-19 pandemic, countries vied for supply contracts. However, as the need for vaccines begins to slow in Europe, some countries want to amend their contracts to reduce spending and to prevent receiving more […]


Manufacturing, Research and Development

Alnylam wins FDA approval of rare disease drug in step toward profitability

June 14, 2022

Via: Biopharma Dive

Alnylam, a pioneer in the drugmaking method known as RNA interference, has climbed the biotech industry ranks over the last two decades. After solving challenges associated with delivering these treatments into the body, Alnylam has become one of the sector’s […]


Manufacturing, Research and Development

Resilience, a well-funded manufacturing startup, joins with the Parker Institute to make cancer drugs

June 9, 2022

Via: Biopharma Dive

While recent years have seen scientists make major advances in cutting-edge treatments such as gene and cell therapies, manufacturing remains a significant hurdle. The complex, multi-step processes required are beyond the capabilities of a traditional pharmaceutical plant. That’s where Resilience […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Regenxbio Opens Gene Therapy Manufacturing Facility

June 9, 2022

Via: Contract Pharma

Regenxbio recently celebrated the opening of its new Manufacturing Innovation Center gene therapy manufacturing facility. “Launching operations at our Manufacturing Innovation Center is an important milestone in the evolution of REGENXBIO,” said Kenneth T. Mills, president and CEO of REGENXBIO. […]


Manufacturing, Research and Development

Sana Biotechnology ditches California manufacturing plans in bid to save $100M

June 2, 2022

Via: FiercePharma

Sana Biotechnology, which raised a whopping $588 million in its initial public offering last year, has inked a deal for new manufacturing space. The preclinical-stage biotech is ditching plans to run its manufacturing operations in Fremont, California, and instead plans […]