PCI Pharma Services is your bridge between life-changing therapies and patients. We offer unparalleled expertise and experience in each stage of the product lifecycle, including drug development, clinical trial supply, commercial launch and ongoing commercial supply, supporting lifesaving medicines to more than 100 countries around the world.
Technological advancements, global market dynamics, and patient-centric approaches are all factors driving the transformation of the parenteral drug market.
Will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased, with approximately 200,000 doses expected to ship 3Q21.
The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.
Garrett Perry, Technical Services Specialists at Teknova09.14.21
Alex Garner will work to further expand and strengthen Avomeen’s formulation and clinical trial manufacturing capabilities to support biopharmaceutical clients.
Emerging innovations and non-antibiotic approaches to address urgent need to control infectious diseases, including multiple-drug resistant ‘super-bugs’
Anshul Gupte will be responsible for technical and scientific oversight of client projects, reporting to John Ross, President of Metrics Contract Services.
Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.
Veklury (remdesivir) with sales of $829 million offsets loss of exclusivity of Truvada and Atripla in the U.S. with sales down 72% and 42%, respectively.
Market estimated to grow at CAGR of 20% from 2021 to 2028 due to an exponential rise in clinical pipeline along with rising number of regulatory approvals.
State-of-the-art R&D lab at Florence, KY site expands technical feasibility capabilities for long-acting delivery of small molecules, biologics and nucleotides.
Aims to address growing demand for scientific and technology solutions for remote data capture, hybrid virtual studies and decentralized clinical trials.
Designed to provide a fast, sensitive range of trace element analysis solutions capable of capturing the complete spectrum of high matrix samples in single run.
Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network.
Initial phase includes installation of two 2,000-liter single-use bioreactors and associated investments to support early-and late-phase clinical development.
Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location
Brings together THREAD's digital platform and Marken's clinical trial logistics services to create a single seamless workflow for clients and patients.
Acquisition is part of the cigarette maker’s ‘Beyond Nicotine’ strategy and expands its product pipeline development capabilities in inhaled therapeutics.
Will leverage integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, designed to detect, target and attack tumor cells.
New product, Corning Valor RTU Vials with SG EZ-fill Technology, offers a unique combination of Corning Valor Glass vial attributes with SG EZ-fill integration.
Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
CDMOs have been some of the biggest winners from COVID contracts and will see benefits for several more years to come. A Q&A with GlobalData’s Peter Shapiro.
Lonza’s Robert Beland discusses best practices for manufacturers to shorten development timelines, as well as some of the capabilities at the CDMO's Tampa site.
Increases capabilities and capacity to provide anti-infective testing, assay development and biomaterial production services for highly infectious pathogens.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
Catalent to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs.
New site in Haimen, Jiangsu province has been established following an invitation to participate in the Yangtze Delta Advanced Drug Development platform.
Lonza exits both softgels and liquid-filled hard capsules and NextPharma plans to broaden its technology offering into lipid based finished dosage forms.
Recognizes manufacturing facility and processes are in compliance with GMP requirements and readiness to provide commercial aseptic fill/finish services.
Exclusive license agreement to incorporate Ajinomoto Co.’s AJICAP site-specific bioconjugation technology for the development of Bright Peak Immunocytokines.
Jointly develop systemic lupus erythematosus assessment review process to enhance data quality and research site personnel experiences and efficiencies.
35-year pharmaceutical industry veteran brings deep industry expertise and a track record of building successful, client-centric, growth organizations.
Will increase 7000L drug substance capacity (MFG21) and drug product capacity (DP11) for liquid and lyophilization within its global manufacturing network.
Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
Treatment could be used for people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease, complementing the vaccine.
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups01.05.21
With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP12.11.20
From discovery to intermediates, APIs & drug products, a CDMO needs expertise across multiple elements of the pharma process to deliver an integrated experience
Large shipping system capable of carrying thousands of doses of vaccines that may require temperatures as low as -80° C using liquid nitrogen technology.
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.
Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA11.13.20
Single-dose intranasal vaccine for COVID-19 designed to generate a broad immune response with nasal mucosal immunity to prevent infection and transmission.
As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.
Leverages Fusion's Targeted Alpha Therapies platform and radiopharmaceuticals expertise and AstraZeneca's portfolio of antibodies and cancer therapies.
Offering now includes Clinical Site-to-Patient, Pharmacy-to-Patient and Depot-to-Patient services to enable medication delivery directly to patients' homes.
ProBioGen is conducting cell line development, process development and GMP manufacturing of the mAb intermediates of Heidelberg’s ATAC molecules for cancer.
Karen will work to further expand the company's contract manufacturing business, which delivers GMP materials to third parties developing COVID-19 vaccines.
Patch could administer vaccines without traditional needles reducing the need for refrigeration in transport and storage, and possibly self-administration.
Fran L. DeGrazio of West discusses why and how vaccine development is different than drug development and the impacts of COVID-19 on vaccine development.
Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.
Adds 258,000 sq.-ft. to current Cookeville footprint and represents expansion into biologics, cold chain storage and third-party logistics distribution.
LAU-7b has shown potent antiviral effects against SARS-CoV-2 and MERS-CoV coronaviruses, and is also being developed for its anti-inflammatory properties.
Kodak Pharmaceuticals will produce critical pharmaceutical components that have been identified as essential but have lapsed into chronic national shortage.
Dr. Ural of Ernst & Young LLP discusses market dynamics, enduring therapeutic areas, near term M&A, and how industry can use this time for transformation
Aji Bio-Pharma provides drug product aseptic fill finish services for CytoDyn's Leronlimab, currently being used in clinical trials for COVID-19 patients
Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.
JoyL Silva of Pfizer CentreOne discusses global market and regulatory changes driving drug development strategies and the evolution of CDMO services and ops.
A look at landmark changes in the management of data in the life sciences over the last 20 years and how the industry has addressed the challenges these develop
As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challenge
Ryan Carpentier, Executive Director of Business Development, Cryoport09.23.19
Vicki Barbur of Battelle discusses real-time microbiology, critical factors determining the rapid method of choice, and accessibility to new technologies
Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standards
The chief executive talks industry trends, challenges and what’s in store for PCI Pharma Services as it continues its rapid growth and global expansion strategy
The use of electronic tongue technology helps firms reduce development times and costs by overcoming challenges associated with traditional testing panels.
Detlev Haack & Martin Koeberle, Hermes Pharma03.06.19
IDDI, BMS Consortium aims to establish that the GPC statistical method can complement the design, analysis and interpretation of clinical trial results
To drive patient enrollment in CBT’s ongoing Phase 1/2 trial of CBT-101 in patients with c-Met dysregulated malignancies including non-small cell lung cancer
The Almac Group has completed a 67,000-sq.-ft. expansion to its facility in Durham, NC, which now houses the company’s Clinical Services and Diagnostics Divisions.