Charkit Names New President; Thermo Fisher Scientific Pharma Services Expands

The latest news from CDMOs, CMOS, and other suppliers featuring news from Charkit, Thermo Fisher Scientific Pharma Services, MilliporeSigma, Charles Rivers, Ompi, and LabVantage.

Chemicals/Chemical API Manufacturing

Charkit Chemical Names New President

Charles Hinnant, CEO of LBB Specialties, a subsidiary of LeBaronBrown Industries, has announced that effective immediately (as of February 5, 2019), Jay Lang has accepted the role of President, Charkit Chemical Company a specialty chemical and ingredients distributor headquartered in Norwalk, Connecticut, and a subsidiary of LBB Specialties.

Mr. Lang succeeds Mr. Hinnant, the company’s Founder, as Charkit’s President. In this role, Mr. Lang will lead all aspects of the Charkit organization, including the sales, marketing, operations, regulatory, and administration functions. He will be tasked with driving revenue and gross profit growth, managing Charkit’s operating functions and improving the efficiency of working capital. He will report directly to Mr. Hinnant.

Mr. Lang has more than two decades of experience at Charkit with roles ranging from key account management to marketing strategy to raw materials management. Most recently, he served as Executive Vice President and a member of the company’s Senior Management Team.

Source: Charkit

Formulation Development/Drug Product Manufacturing

Thermo Fisher and Pacira Expand Manufacturing Capacity

Pacira Pharmaceuticals, a specialty pharmaceutical company based in Parsippany, New Jersey, has initiated commercial production of Exparel (bupivacaine liposome injectable suspension), indicated for postsurgical analgesia, at a custom suite in Swindon, UK, created under the company’s partnership with Thermo Fisher Scientific Pharma Services.

This first suite was designed to mirror the company’s existing facility at the Pacira Science Center Campus in San Diego, California, and is expected to double the company’s manufacturing capacity. Through the partnership, the companies are developing a second dedicated suite that is expected to enable another doubling of Exparel manufacturing capacity in approximately two years. Pacira says the expansion will meet growing customer demand in the US and support expansion into new global markets, such as Europe and Asia.

Exparel is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

Source: Pacira Pharmaceuticals


Ompi, SiO2 Medical Products Enter Packaging Collaboration Agreement

Stevanato Group, a producer of glass parenteral packaging for pharmaceuticals, headquartered in Padua, Italy, through Ompi, its specialist in glass primary packaging, and SiO2 Medical Products, a packaging manufacturer headquartered in Auburn, Alabama, have formed a collaboration agreement. The collaboration will enable pharmaceutical and biologics customers, contract filling organizations, and research laboratories to receive SMP’s proprietary primary containers in Ompi’s EZ-fill packaging configurations in trays and nest & tubs.

Source: Stevanato Group

Haselmeier Acquires Drug-Manufacturing License for Self-Injection Systems

Haselmeier, a developer and manufacturer of self-injection devices, based in Switzerland, acquired a drug-manufacturing license in December 2018 to permit the manufacturing of pharmaceuticals in accordance with German and European Union regulatory requirements (§13 of the Medicines Act (Arzneimittelgesetz – AMG and Art. 40 of Directive 2001/83/EC) and now provides assembly, labelling and packaging services to pharmaceutical and biotechnology companies.

Haselmeier partners with pharmaceutical and biotechnology companies to develop and produce customized self-injection systems. It assembles the cartridges supplied by customers for the respective therapies with the injection pens as well as labels and packages the combination products. This service also includes the manufacture of batches for stability testing.

The Haselmeier products are manufactured in production facilities in Buchen, Odenwald, Germany, Dnešice, Czech Republic, and Bengaluru, India. The company employs around 200 people worldwide.

Source: Haselmeier


MilliporeSigma Receives Its First US Patent for CRISPR Genome-Editing

MilliporeSigma reports that the US Patent and Trademark Office has issued a formal notice allowing MilliporeSigma’s patent application directed to its proxy-CRISPR (clusters of regularly interspaced short palindromic repeats) technology.

MilliporeSigma’s proxy-CRISPR is a new genome-editing technique that the company says makes CRISPR more efficient, flexible, and specific by opening the genome for modification of DNA. It says the technology can help scientists modify regions of the genome that are difficult to access, thereby increasing increasing genome coverage

To deploy the proxy-CRISPR method, two CRISPR systems are designed to target the genome in proximity to each other and work together, according to information from the company. One CRISPR system opens a regional “door,” pushing away blocking chromatin proteins while the other walks through it to find the exact location for modification. Since the resulting modification requires two CRISPR-binding events, the proxy-CRISPR method can enable twice the specificity of individual CRISPR systems, according to the company.

This US patent allowance marks MilliporeSigma’s 13th CRISPR patent worldwide. MilliporeSigma’s CRISPR patent portfolio includes granted patents in Australia, Canada, Europe, Singapore, China, Israel and South Korea. Those patents are for CRISPR-related technologies covering foundational and alternative genome-editing methods.

Source: MilliporeSigma

Charles River Laboratories to Acquire Citoxlab for $510 Million

Charles River Laboratories International, a provider of research tools and support services for drug discovery and development, headquartered in Wilmington, Massachusetts, has signed a binding offer to acquire Citoxlab, a non-clinical contract research organization (CRO) based in Evreux, France for EUR 448 million ($510 million).

Citoxlab specializes in regulated safety-assessment services, non-regulated discovery services, and medical-device testing, with operations in Europe and North America. The proposed acquisition is expected to add $115 million to $130 million to Charles River’s 2019 consolidated revenue based on the anticipated 2Q close, and approximately $200 million to 2020 consolidated revenue.

The proposed transaction is expected to close in the second quarter of 2019, subject to labor consultations, regulatory requirements, and customary closing conditions. Upon completion of the labor consultations, Citoxlab’s shareholders are expected to enter into a definitive purchase agreement.

Marken to Expand Philadelphia Clinical Logistics Facilities

Marken, a supply-chain organization for the pharmaceutical and life-sciences industries and a wholly owned subsidiary of UPS, will expand its facilities in Philadelphia to include more space for logistics operations as well as a new GMP-compliant storage and distribution center. The facility is for clinical drug handling.

Source: Marken

LabVantage Solutions Launches Laboratory Informatics Software

LabVantage Solutions, a provider of laboratory informatics solutions and services headquartered in Somerset, New Jersey, has launched LabVantage 8.4, the latest version of its laboratory informatics software. LabVantage 8.4 incorporates advanced work and resource planning functions that allows enhanced efficiency for the laboratory manager. Updates include features for work planning and managing resource capacity and availability as well as enhanced capabilities to ensure data privacy.

Source: LabVantage

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